Cochrane

# Supplementary material 5 to:
Interventions for preventing falls in older people living in the community

Gillespie LD , Robertson MC , Gillespie WJ , Sherrington C , Gates S , Clemson L , Lamb SE
https://doi.org/10.1002/14651858.CD007146.pub3

Cochrane disclaims all liability and responsibility arising from any reliance placed on this supplementary material which has been supplied by the author(s). The above associated publication’s Author Licence will apply in respect of any supplemental materials published. How to cite the supplementary material is defined in the Cochrane policy.

# Characteristics of ongoing studies

## Table of contents

- Studies ordered by study ID
  - ACTRN012606000023550
  - ACTRN12607000017426
  - ACTRN12607000018415
  - ACTRN12607000206426
  - ACTRN12607000563460
  - ACTRN12610000576022
  - ACTRN12610000805077
  - ACTRN12610000838011
  - Ferrer 2010
  - ISRCTN10538608
  - ISRCTN11861569
  - ISRCTN43453770
  - ISRCTN48015966
  - ISRCTN57066881
  - ISRCTN60481756
  - ISRCTN68240461
  - ISRCTN71002650
  - NCT00413933
  - NCT00483275
  - NCT00934531
  - NCT00946062
  - NCT00986466
  - NCT01029171
  - NCT01032252
  - NCT01080196
  - NCT01358032
  - NCT01452243
  - NTR1593
- Footnotes
- References to studies

## Studies ordered by study ID

ACTRN012606000023550
Study name | Healthy Steps: A trial of pedometer-based Green Prescription to improve physical activity, health-related quality of life, and health and physical functioning in low-active older adults
Methods | RCT
Participants | Target sample size: 350 Inclusion criteria: aged ≥ 65; < 50 min of moderate physical activity over at least 5 days in a week; living in Auckland for next 12 months; sufficient understanding of English to permit physician and telephone counselling. Exclusion criteria: walking contraindicated due to health problem; visually impaired, i.e. unable to read step counts on a pedometer
Interventions | Intervention: pedometer-based New Zealand Green Prescription (primary care physician counselling and telephone counselling using motivational interviewing and cognitive behavioural techniques incorporating step-based physical activity goals for 3 months) Control intervention: conventional time-based Green Prescription (as above, but incorporating conventional time-based physical activity goals for 3 months)
Outcomes | Falls and injuries are secondary outcomes Cost-effectiveness analysis
Starting date | 1 March 2006
Contact information | Prof G Kolt School of Biomedical and Health Sciences University of Western Sydney Locked Bag 1797, Penrith South DC NSW 1797 Email: g.kolt@uws.edu.au
Notes |

ACTRN12607000017426
Study name | Individual nutrition therapy and exercise regime: A controlled trial of injured, vulnerable elderly (INTERACTIVE trial)
Methods | RCT
Participants | N = 460 Inclusion criteria: community-dwelling, aged > 70, in hospital after a proximal femoral fracture, MMSE ≥ 18/30, body mass index between 18.5 kg/m2 and 35 kg/m2 Exclusion criteria: pathological fracture, unable to give consent, medically unstable 14 days after surgery
Interventions | 1. Intervention: 6-month individualised exercise and nutrition programme commencing within 14 days post-surgery. Weekly home visits. 2. Attention control. Weekly social visits.
Outcomes | Falls monitored at weekly visit for 6 months. 12-month follow-up in the community
Starting date | June 2007 to September 2009
Contact information | Dr MD Miller Department of Nutrition and Dietetics Flinders University Adelaide South Australia Australia Email: michelle.miller@flinders.edu.au
Notes |

ACTRN12607000018415
Study name | An evaluation of the Accident Compensation Corporation (ACC) Tai Chi programme in older adults: does it reduce falls
Methods | RCT. Central randomisation using specialist computer program (see: http://www.randomization.com/), stratified by site and blocked to ensure balanced numbers over the 3 interventions.
Participants | Target sample size: 684 Inclusion criteria: men and women; over 65 years (55 years if Maori or Pacific Islander); history of at least 1 fall in the previous 12 months or have a falls risk factor according to the Falls Risk Assessment Tool (FRAT) Exclusion criteria: unable to walk independently (with or without walking aid), chronic medical condition that would limit participation in low-moderate exercise, severe cognitive limitations (telephone Mini Mental State Examination score < 20), currently participating in an organised exercise programme of equivalent intensity as the study intervention
Interventions | All training sessions are of 1 hour duration for a 20-week period 1. Intervention: Tai Chi training 1 x week 2. Intervention: Tai Chi training 2 x week 3. Control: flexibility training 1 x week
Outcomes | Falls at 20 wks, 6 months and 12 months
Starting date | 30 August 2006 (closed; follow-up continuing)
Contact information | Dr Denise Taylor Physical Rehabilitation Research Centre School of Physiotherapy Auckland University of Technology (AUT) Akoranga Campus Northcote Auckland Telephone: +64 9 9219680 Email: denise.taylor@aut.ac.nz
Notes |

ACTRN12607000206426
Study name | Community Care and Hospital Based collaborative Falls Prevention Project
Methods | RCT
Participants | Target sample size: 200 Inclusion criteria: male or female, aged ≥ 65, presenting to A&E or falls clinic, community-dwelling in Perth north Exclusion criteria: functional cognitive impairment, unable to speak or read English
Interventions | 1. Intervention: community follow-up by support worker (8 hours over 2 to 3 wks) to review risk factors in the home, strategies to reduce risk factors, assistance to implement Falls Action Plan provided by A&E or clinic (see ANZCTR website for further details). 2. Control: no community follow-up after discharge
Outcomes | Number of falls (falls calendar)
Starting date | April 2007
Contact information | J Johnson Perth Home Care Services 30 Hasler Road PO Box 1597 Osborne Park Western Australia 6017 Australia
Notes | Emailed author 3 August 2011 as still listed as "Not yet recruiting". Email bounced.

ACTRN12607000563460
Study name | Minimising disability and falls in older people through a post-hospital individualised exercise programme
Methods | RCT
Participants | N = 340 Sample: people recently discharged from hospital Inclusion criteria: aged > 60 Exclusion criteria: medically unfit for exercise; progressive neurological condition; cognitive impairment; nursing home resident
Interventions | 1. Home-based exercise programme: based on the Weight-bearing Exercise for Better Balance programme, 10 1-hour visits from a physiotherapist over 12 months. Individually prescribed exercises targeting postural control (balance) and lower limb muscle strength (30 min 6 times a week for 12 months). 2. Control: usual care
Outcomes | 1. Rate of falls
Starting date | 2007
Contact information | C Sherrington The George Institute for Global Health PO Box M201 Missenden Road NSW 2050 Australia
Notes | Data analysis in progress

ACTRN12610000576022
Study name | Frails' Fall Efficacy by Comparing Treatments (EFFECT)
Methods | RCT
Participants | N = 80 Sample: people recruited via SGH geriatric medicine department, SGH Lifestyle Improvement Fitness Enhancement Centre Osteoporosis and Bone Metabolism unit, SGH Physiotherapy Falls Clinic and public volunteers Inclusion criteria: aged 60 to 85; community-dwelling; ambulating independently; with fear of falling; able to commit to 12-week intervention; moderately frail (SPPB score 5 to 9): speak or understand English, Mandarin, or local dialects Exclusion criteria: cognitively impaired; untreated medical conditions; life expectancy < 1 year; unstable cerebral haemorrhage, pulmonary embolism, deep vein thrombosis or surgery in the past 3 months; a healing fracture
Interventions | 1. Intervention: Nintendo Wii Active (small group with PT supervision): 1 hr, 1 x per wk for 12 wks (10 min stretching, 20 min WiiActive game play including resistance band training, balance and co-ordination training, calisthenics, and cardiovascular training, 15 min home exercise education, 15 min participant-specific management) + home exercises 0.5 to 1 h 2 x per wk for 24 wks (progressive resistance training with exercise bands) + home safety handout and advice 2. Control: traditional exercise group: as above but 20 min cardiovascular training instead of WiiActive game + home exercises as above + home safety handout and advice as above
Outcomes | 1. Number of falls 2. Economic analysis Other outcomes not included in this review
Starting date | June 2010
Contact information | BC Kwok Block 3 Level 1 Dept of Physiotherapy Singapore General Hospital Outram Road Singapore 169608 Email: kwok.boon.chong@sgh.com.sg
Notes | Falls efficacy the primary outcome. Falls not mentioned in trial registration form. Kwok 2011 states falls monitored but no description of how they will be analysed.

ACTRN12610000805077
Study name | RESTORE: Recovery exercises and Stepping On after fracture
Methods | RCT
Participants | Target sample size: 350 Inclusion criteria: people with a fall-related lower limb or pelvic fracture who have completed active physiotherapy and/or rehabilitation and who are living at home or in a hostel Exclusion criteria: residing in nursing home; Mini Mental State Examination (MMSE) < 24; insufficient English language skills; inability to walk 10 metres despite assistance from another person or walking aid; progressive neurological disease; a medical condition precluding exercise
Interventions | 1. Home visits from a physiotherapist to prescribe an individualised exercise programme and use motivational interviewing and goal setting to encourage behaviour change with regard to exercise, also offered the Stepping On programme as implemented by the NSW Department of Health: weekly 2-hour group discussion sessions for 7 weeks plus an additional booster session at 3 months 2. Usual care control
Outcomes | 12-month follow-up. Rate of falls and the proportion of fallers in intervention and control groups
Starting date | 2010
Contact information | C Sherrington The George Institute for Global Health PO Box M201 Missenden Rd NSW 2050 Australia
Notes |

ACTRN12610000838011
Study name | CONFABS study (Concord Falls and Bone Service)
Methods | RCT
Participants | N = 400 Sample: men and women Inclusion criteria: aged ≥ 65; ≥ 1 fall in preceding 12 months; community-dwelling (house, flat, retirement village, hostel); independently mobile with or without walking aids; resident in the study area for the following 12 months Exclusion criteria: cognitive impairment MMSE < 20/30; terminal illness with life expectancy less than 12 months; Parkinson's disease or other neurodegenerative conditions; unable to understand English; had comprehensive Geriatric Assessment in the preceding 12 m; has not attended a General Practitioner in the preceding 12 months; no usual General Practitioner
Interventions | Testing a service model for delivery of a fall prevention programme 1. Specialist Falls and Bone service - co-ordinated targeted multifactorial falls prevention interventions and adequate assessment and treatment of osteoporosis. Initial nurse assessment, geriatrician assessment at wk 2, wk 6, 4 months, 12 months. Treatment of osteoporosis (calcium and vitamin D), fall prevention co-ordinated and arranged by the geriatrician (community-based physiotherapists, occupational therapists, and podiatrists) etc. 2. General Practice (GP) co-ordinated use of targeted multifactorial falls prevention interventions. Enhanced GP service model with falls risk assessment and generic advice provided by the research team for co-ordination by the GP. The GP is the usual practitioner caring for the participant. There will be no specific GP education, but there exists ongoing education sessions given by the Principal Investigator to the local GP network as part of continuing medical education.
Outcomes | 1. Rate of falls 2. Number of fallers 3. Number of injurious falls
Starting date | 13 September 2010
Contact information | Dr Nichola Boyle Centre for Education and Research on Ageing Building 18, Concord Hospital Hospital Road Concord, NSW 2139, Australia Telephone: +61 2 9767 8356 Email: nichola.boyle@sydney.edu.au
Notes |

Ferrer 2010
Study name | The OCTABAIX study
Methods | RCT
Participants | N = 328 Aged ≥ 85 Inclusion criteria: community-dwelling
Interventions | 1. Multifactorial intervention. 3 home visits annually from trained nurse or physician. "Two face-to-face interventions will be carried out". Telephone calls to promote adherence. Control: routine primary care
Outcomes | Falls and malnutrition
Starting date | Not stated
Contact information | A Ferrer Centro de Atencion Primaria El Pla Sant Feliu de Llobregat Barcelona Spain Emaik: aferrer.cp.ics@gencat.cat
Notes |

ISRCTN10538608
Study name | SAFER (Support and Assessment for Fall Emergency Referrals) Trial
Methods | RCT (cluster-randomised)
Participants | Setting: 3 ambulance services in England and Wales, United Kingdom N = 72 paramedics Sample: paramedics and their patients meeting the following inclusion criteria Inclusion criteria: (patients) aged ≥ 65 years; living in study area but not in residential care, have called emergency services as a result of a fall Exclusion criteria: none
Interventions | Intervention testing service delivery 1. Paramedic training in use of hand-held computerised clinical decision support (CCDS) to help decide who needs hospital attendance, and who can be safely left at home with referral to community falls services 2. Control: usual emergency ambulance service care at each study site, i.e. a paper-based decision support system in the form of a structured questionnaire
Outcomes | 1. Time to first fall (identified by ED attendance or call for emergency services) 2. Number of falls (self reported)
Starting date | 1 August 2006 (completed)
Contact information | Prof H Snooks School of Medicine, Swansea University Singleton Park Swansea SA2 8PP United Kingdom Email H.A.Snooks@swansea.ac.uk
Notes |

ISRCTN11861569
Study name | ISRCTN11861569
Methods | RCT
Participants | Setting: Quebec, Canada N = 152 Sample: admitted to a geriatric day hospital programme Age (years): mean (SD) Inclusion criteria: aged > 65 yrs; high risk of falling (Berg balance scale score ≤ 49/56 and at least 1 accidental fall in the previous 6 months); multiple disabilities; not cognitively impaired (> 65 at the 3MS test) Exclusion criteria: unfit for physical activities following a medical assessment; presenting a mental or physical condition incompatible with physical activities
Interventions | 1. Intervention: Tai Chi: 1 hour, 2 x per day for 15 wks in groups of 4 to 6 subjects 2. Control: conventional physiotherapy balance training for 1 hour, 2 x per day for 15 wks
Outcomes | 1. Falls per person year 2. Time to first fall 3. Cost-effectiveness
Starting date | 1 October 2002 to 30 June 2007 (Completed)
Contact information | Dr Michel Tousignant Centre de recherche sur le vieillissement I.U.G.S. - Pavillon D'Youville 1036, rue Belvédère Sud Sherbrooke J1H 4C4 Canada Email: Michel.Tousignant@USherbrooke.ca
Notes | One paper published but this doesn't contain falls results or planned economic evaluation. Additional paper submitted for publication 2011, but not yet accepted.

ISRCTN43453770
Study name | Promoting physical activity in people aged 65+ (ProAct65+)
Methods | RCT (cluster-randomised, multicentre)
Participants | Target sample size: 1200 Inclusion criteria: aged 65+; able to ambulate independently indoors and outdoors (with or without a walking aid); able to take part in a group exercise class; living independently (i.e. not in residential or nursing care); not receiving long-term physiotherapy Exclusion criteria: ≥ 3 falls in the previous year; resting BP > 180/100 mmHg, tachycardia > 100 bpm, uncontrolled hypertension, significant drop in BP during exercise recorded in the medical records or found at initial assessment; psychiatric conditions which would prevent participation in an exercise class; medical problems which the GP considers a contraindication to exercising, e.g. acute systemic illness, poorly controlled angina; conditions requiring a specialist exercise programme, e.g. uncontrolled epilepsy, significant neurological disease or impairment; significant cognitive impairment
Interventions | 24 wk intervention Arm 1: home-based exercise programme (OEP) (N = 400) Progressive leg muscle strengthening and balance retraining exercises at home (30 min, ≥ 3 times per week), advised to walk ≥ 2 times per week for ≥ 30 min at a moderate pace, for 24 weeks. Trained peer mentors will contact and visit the patients at their home at start. 3 more home visits/exercise sessions as required. Arm 2: community-based exercise programme (FaME) (N = 400) Hour long PSI-delivered group exercise class in a local community centre for a maximum of 15 participants, and 2 30-minute home exercise sessions (based on the OEP) per week, for 24 weeks. Participants will also be advised to walk at least twice per week for up to 30 min at a moderate pace. Arm 3: 'treatment as usual' group (n = 400) 24-month follow-up
Outcomes | 1. Rate of falls 2. Number of people falling Other outcomes not included in this review
Starting date | Anticipated 1 June 2008 to 31 May 2013
Contact information | Prof S Iliffe Department of Primary Care & Population Health University College London Rowland Hill Street London NW3 2PF United Kingdom
Notes |

ISRCTN48015966
Study name | The Chaos Clinic for prevention of falls and related injuries: a randomised, controlled trial
Methods | Pragmatic randomised controlled trial
Participants | Target sample size: 3200 Inclusion criteria: home-dwelling; aged ≥ 70; high risk for falling and fall-induced injuries and fractures
Interventions | 1. Intervention: baseline assessment and general injury prevention brochure plus individual preventive measures by Chaos Clinic staff based on baseline assessment: physical activity prescription, nutritional advice, individually tailored or group exercises, treatment of conditions, medication review, alcohol reduction, smoking cessation, hip protectors, osteoporosis treatment, home hazard assessment and modification 2. Control: baseline assessment and general injury prevention brochure alone
Outcomes | Falls and fall-related injuries, especially fractures Measured by phone calls at 3 and 9 months, and on follow-up visits at 6 and 12 months from the beginning
Starting date | January 2005 (completed)
Contact information | Dr M Palvanen The Urho Kaleva Kekkonen (UKK) Institute for Health Promotion Research PO Box 30 Tampere FIN-33501 Finland
Notes |

ISRCTN57066881
Study name | The Home-Based Older People's Exercise (HOPE) trial
Methods | RCT (pilot study)
Participants | Setting: Bradford, United Kingdom Target sample size: 100 Sample: frail older people identified through case management service for community-dwelling, via GP registers (housebound), day care centres, respite care, on discharge from intermediate care hospitals, elderly medicine outpatient departments Inclusion criteria: long-term chronic illness; housebound; no age limits Exclusion criteria: unable to stand or walk independently; participating in an exercise programme; registered blind; poorly controlled angina; severe dementia; receiving palliative care
Interventions | 1. The HOPE programme: 12 wk progressive exercise intervention to improve strength, mobility, balance, or aerobic capacity (5 repetitions progressing to 10 and 15, 3 x per day, 5 days per wk). Training manual + weekly support from community PT. 2. Control: usual care
Outcomes | Falls a secondary outcome in trial registration form but not in paper, which just states that falls will be recorded. Not clear whether as an outcome or adverse events. Primary outcomes not included in this review.
Starting date | 15 July 2010
Contact information | Dr AP Clegg Institute for Health Research Duckworth Lane Bradford BD9 6RJ United Kingdom
Notes |

ISRCTN60481756
Study name | SAFER 2: Support and Assessment for Fall Emergency Referrals
Methods | Cluster-randomised trial
Participants | Setting: ambulance stations in 3 participating ambulance services (London, Wales, and East Midlands) Sample: men and women making a 999 call for emergency services after a fall Target sample size: 6548 Inclusion criteria: aged ≥ 65 Exclusion criteria: not living within study area
Interventions | 7-month intervention Intervention: emergency ambulance paramedics in randomised stations implement a protocol for older people who have fallen which allows them to assess and refer appropriate patients to a community-based falls service Control: continue to provide care according to their standard practice
Outcomes | 1. Further emergency health care contacts (999 call or ED attendance) for fall per recruited faller and time to first contact 2. Costs of care Other outcomes not included in this review
Starting date | April 2009
Contact information | Prof Helen Snooks Swansea University Singleton Park Swansea SA2 8PP United Kingdom Email: h.a.snooks@swansea.ac.uk
Notes | Estimated date of publication late 2013. Protocol available at www.hta.ac.uk/protocols/200700010021.pdf

ISRCTN68240461
Study name | Randomised trial of a multifaceted podiatry intervention for fall prevention in patients over 70 years of age
Methods | RCT
Participants | Target sample size: 890 Inclusion criteria: people aged > 70 years; history of 2 falls within the past 12 months or 1 fall which required hospital attention; complete baseline or run-in data collection instruments adequately Exclusion criteria: neuropathy; neurodegenerative disorder; dementia; unable to walk household distances (10 m); lower limb amputee; already have adapted footwear which would not allow an orthotic to be fitted; unable to read or speak English
Interventions | 1. Multifaceted podiatry intervention consisting of footwear assessment and advice and financial assistance in purchasing more appropriate footwear if required; routine podiatry care; foot orthoses; home-based foot and ankle exercises; falls prevention leaflet based on National Institute for Health and Clinical Excellence (NICE) guidance 2. Control: falls prevention leaflet based on NICE guidance
Outcomes | 1. Rate of falls 2. Number of people falling Other outcomes not included in this review.
Starting date | 1 October 2011
Contact information | David Torgerson University of York, Department of Health Sciences York Trials Unit, ARRC Building Heslington YO10 5 DD York, UK Email: david.torgerson@york.ac.uk
Notes |

ISRCTN71002650
Study name | Pre-FIT: Prevention of Fall Injuries Trial
Methods | A 3-arm, cluster-randomised controlled trial with economic evaluation
Participants | Target sample size: 9000 Inclusion criteria: people aged over 70 years living in the community, including people in sheltered accommodation Exclusion criteria: living in nursing or residential care homes
Interventions | 1. Advice: based on best practice guidelines and evidence for positive framing of information, e.g. improving mobility 2. Exercise: based on the Otago Exercise Programme and delivered over at least 12 wks either on a group basis or at home 3. Multi-Factorial Fall Prevention: based on the Tinetti programme and updated in a consensus building exercise
Outcomes | Primary outcome is peripheral fracture, expressed as number of people with any peripheral fracture, and peripheral fracture rate per person years of observation Secondary outcomes include health-related quality of life, fall rate per person years, time to first fracture, resource use, and mortality
Starting date | 1 April 2011
Contact information | Pre-FIT Trial Co-ordinator Warwick Clinical Trials Unit Warwick University Coventry CV4 7AL Tel: +33 24 765 74656 Email: prefit@warwick.ac.uk
Notes |

NCT00413933
Study name | Comprehensive interventions for falls prevention in the elderly
Methods | RCT
Participants | Target sample size: 200 Inclusion criteria: aged ≥ 65; ≥ 1 falls in past 12 months; belonging to Clalit HMO; mobile outdoors without wheelchair.Exclusion criteria: seriously ill, e.g. dyspnoea with light exercise, unstable heart disease; MMSE < 18
Interventions | 1. Intervention: multidisciplinary assessment by geriatrician, physiotherapist, and OT (home hazard assessment) plus at least 1 of the following: recommend medication adjustment or referral to optometrist or ophthalmologist to family physician; exercise sessions with physiotherapist; OT advice to change unsafe home hazards 2. Control: usual care
Outcomes | Primary outcome: fall rates (falls self reported by phone) Secondary outcomes: safety, cost of healthcare utilisation and rate of hospitalisation
Starting date | January 2008
Contact information | Dr Yan Press Ben-Gurion University of the Negev, Israel Email: yanp@zahav.net.il
Notes |

NCT00483275
Study name | Fall prevention by alfacalcidol and training
Methods | RCT
Participants | Target sample size: 484 men and women Inclusion criteria: aged ≥ 65; ≥ 1 fall in past year or earlier if increased fall risk; creatinine clearance 30 to 60 ml/min (i.e. moderately impaired kidney function); community-dwelling Exclusion criteria: hypercalcaemia, taking vitamin D; dementia; fracture or stroke in preceding 3 months etc (see ClinicalTrials.gov for details)
Interventions | 1. Intervention: 1 µg alfacalcidol and 500 mg calcium daily; mobility programme (strength, balance, and gait training (1 hour, 2 x per wk); patient education (single meeting with teaching lessons on risk factors for falling and modes of fall prevention followed by an evaluation of the individual fall risk and corresponding recommendations to reduce it) 2. Control: usual care
Outcomes | Follow-up for 1 year. Number of fallers, number of falls, number of fractures, fear of falling, balance performance, hypercalcaemia
Starting date | June 2007 to September 2009
Contact information | Dr J Schumacher Klinik für Altersmedizin und Frührehabilitation, Marienhospital, Ruhr-Universität Bochum, Herne, NRW, Germany, 44627 Telephone: +49 2323 499 0 ext 5918 Email: jochen.schumacher@rub.de
Notes | Open label trial sponsored by Teva Pharmaceutical Industries

NCT00934531
Study name | Donepezil and the risk of falls in seniors with cognitive impairment
Methods | RCT
Participants | Target sample size: 140 Source: people with mild cognitive impairment recruited from Aging Brain and Memory Clinic, Parkwood Hospital Inclusion criteria: age 65 to 100; mild cognitive impairment; BMI 18 to 30; acceptable blood pressure; about to walk 10 m independently without any gait aid; able to travel to clinic for assessments Exclusion criteria: unable to understand English; low body weight; possible Alzheimer's disease; taking herbal preparations such as St. John's Wort and Gingko biloba; history of drug or alcohol abuse/dependence; history of psychiatric illness within the last 2 years, including depression; Parkinsonism or any neurological disorder with residual motor deficit; musculoskeletal disorder affecting gait performance; active osteoarthritis affecting the lower limbs; use of psychotropic medication, an anticholinergic agent (benztropines), other acetylcholinesterase inhibitors or cholinergic agents (bethanechol); comorbidities which may contradict use of ChEIs; history of chronic bradycardia or sick sinus syndrome; severe COPD and/or asthma; history of seizure disorders
Interventions | 1. Intervention: 5 mg/day of donepezil (Aricept) p.o. for 4 wks, then 10 mg/day of donepezil p.o. for a period of 5 months 2. Control: matched placebo p.o. for 4 wks, then a new matched placebo p.o. for the next 5 months
Outcomes | Number of falls (over 6 months follow-up) Other outcomes not included in this review
Starting date | September 2009 to June 2012
Contact information | Dr M Montero Odasso Dept. of Medicine, Div. of Geriatric Medicine Parkwood Hospital The University of Western Ontario London, Ontario Canada
Notes |

NCT00946062
Study name | Evaluation of a standardised orientation and mobility training in older adults with low vision
Methods | RCT
Participants | N = 190 Inclusion criteria: aged ≥ 55; low vision; living independently in the community or home for older people; able to see large obstacles, able to go outside for a short walk; one of the following: experiencing difficulties with safely crossing a street or difficulties recognising acquaintances outdoors, willing to become recognisable as being partially sighted by using the identification cane Exclusion criteria: cognitive impairment (< 4 on Abbreviated Mental Test); language or hearing problems impeding telephone interview; bed ridden; possible nursing home admission; using a walking aid incompatible with the use of an identification cane; recently received an O&M-training in the use of an identification cane and permanent use of this cane
Interventions | 1. Intervention: standardised orientation and mobility training (O&M-training) in use of identification cane 2. Control group: usual care, i.e. regular O&M-training
Outcomes | Number of falls (indoors and outdoors) over 6 months (described in paper, but not in trial registration) Other outcomes not included in this review
Starting date | November 2007 to July 2010
Contact information | GAR Zijlstra Maastricht University Department of Health Care and Nursing Science Maastricht the Netherlands Email: R.Zijlstra@zw.unimaas.nl
Notes |

NCT00986466
Study name | Vitamin D and exercise in falls prevention (DEX)
Methods | RCT (factorial design)
Participants | Target sample size: 400 Inclusion criteria: women; aged 70 to 80 years; independently community-dwelling; history of at least 1 fall in previous year; no contraindication to exercise; giving informed consent Exclusion criteria: undertaking moderate-to-vigorous exercise more than 2 hours per wk; regular user of vitamin D, or calcium + vitamin D supplements; recent fracture (during preceding 12 months); contraindication or inability to exercise; marked decline in the basic activities of daily living (ADL-test); cognitively impaired (MMSE < 18); chronic conditions, e.g. Parkinson's disease
Interventions | 1. Exercise with vitamin D: 20 µg of vitamin D per day for 2 years supervised training (2 x per wk for 52 wks), and 1 x per wk for next 52 wks 2. Exercise with placebo: as above 3. No exercise with vitamin D: 20 µg of vitamin D per day for 2 years, no supervised training (maintenance of their current level of physical activity) 4. No exercise with placebo: placebo per day for 2 years, no supervised training (maintenance of their current level of physical activity)
Outcomes | 1. Rate of falls 2. Number of people falling 3. Number sustaining a fracture Other outcomes not included in this review
Starting date | September 2009 (completion date December 2014)
Contact information | Dr K Uusi-Rasi, PhD UKK Institute for Health Promotion Research Tampere, Finland
Notes |

NCT01029171
Study name | Action Seniors! Exercise to prevent falls
Methods | RCT
Participants | Target sample size: 344 Source: people attending a Falls Prevention Clinic Service Inclusion criteria: aged > 70 years; proficient English speaker; MMSE > 24/30; history of 1 non-syncopal fall in the last 12 months and one of the following: a) PPA score of at least 1 SD above normal; OR 2) Timed Up and Go Test (TUG) > 15 seconds; OR 3) 1 additional documented non-syncopal fall in the previous 12 months; expected to live > 12 months; community-dwelling; able to walk 3 m with or without an assistive device; consenting Exclusion criteria: history of neurodegenerative disease, dementia, stroke, peripheral neuropathy or severe musculoskeletal or joint disease, or history indicative of carotid sinus sensitivity
Interventions | 1. 12-month home-based balance and strength restraining programme (Otago Exercise Programme) delivered by a physical therapist 2. Control: usual care as prescribed by geriatrician
Outcomes | Falls over a 12-month period
Starting date | November 2009
Contact information | Jenna Homer Centre for Hip Health and Mobility Vancouver, BC Canada Email: mailto:jenna.homer%40hiphealth.ca?subject=NCT01029171, H04-70171, Action Seniors! Exercise to Prevent Falls
Notes |

NCT01032252
Study name | Prevent Falls (PreFalls)
Methods | RCT (cluster-randomised)
Participants | N = 382 Sample: community-dwelling people registered with general practices Inclusion criteria: aged 65 and older; with at least 1 of the following: fall within last 12 mo; fear of falling; chair-stand-ups > 10 sec; Timed-up-and-go-Test > 10 sec; impaired balance; self reported balance deficits Exclusion criteria: not living independently; with physical or mental restrictions which don't allow exercising or participating in falls risk assessments
Interventions | 1. Intervention: group and home-based exercises (progressive strength and flexibility training; challenging balance; gait and motor co-ordination training; progressive endurance training). Fear of falling cognitive behavioural intervention (Matter of Balance programme). 60 min, 1 x per wk for 16 wks 2. Control: no intervention
Outcomes | Number of falls per person per year Monthly falls diary for 24 months Also assessed but not included in this review: Other risk and balance outcomes
Starting date | April 2009 to April 2012
Contact information | Dr. med. Wolfgang Blank Institute of General Practice Klinikum rechts der Isar, Technische Universitaet Muenchen Orleanstr. 47 81667 Muenchen Germany Telephone: +49 89 614658913 Email: blank@lrz.tum.de
Notes |

NCT01080196
Study name | Reducing falls with RENEW in older adults who have fallen
Methods | RCT
Participants | Target sample size: 100 Sample: men and women between 65 and 95 years Inclusion criteria: 2 or more self reported co-morbid conditions; history of ≥ 1 fall in last 12 mo; ambulatory; community-dwelling; gait speed 25 m/min to 80 m/min; with permission from physician to participate in a 60-minute (with rests) exercise programme; capable of performing RENEW on the ergometer Exclusion criteria: dementia; progressive neurologic disease or disease affecting muscle, e.g. Parkinson's, muscular dystrophy: participated in a regular (3 x per wk) aerobic or resistance exercise programme in past 12 months; any contraindication to having magnetic resonance imaging
Interventions | 1. High-intensity (lower body) Resistance Exercise via Negative, Eccentrically-induced Work (RENEW) 2. Traditional lower body resistance exercise Both "as part of a multi-component exercise and fall-reduction program" (not described)
Outcomes | 1. Incidence of falls and near falls Other outcomes not included in this review
Starting date | April 2008 to February 2013
Contact information | Sheldon B Smith Department of Physical Therapy University of Utah Salt Lake City Utah United States Email: mailto:sheldon.smith%40hsc.utah.edu?subject=NCT01080196, 26292, Reducing Falls With RENEW in Older Adults Who Have Fallen
Notes | Principal Investigator: Paul C LaStayo

NCT01358032
Study name | A Matter of Balance at Home (AMB-Home)
Methods | RCT
Participants | N = 389 Sample: random sample from municipal registry offices registers Inclusion criteria: reported some concern about falls; at least some associated avoidance of activity; general health as fair or poor; community-dwelling; aged 70 years or older; gave informed consent. Exclusion criteria: confined to bed; restricted by the permanent use of a wheelchair; waiting for a nursing home admission; substantial hearing or vision impairment; cognitively impaired.
Interventions | 1. In-home multicomponent cognitive behavioural programme 2. Control
Outcomes | Number of falls Other outcomes not included in this review
Starting date | March 2009. Final results due 2012
Contact information | GIJM Kempen, PhD Maastricht University CAPHRI School for Public Health and Primary Care
Notes |

NCT01452243
Study name | Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD)
Methods | RCT
Participants | N = 704 Sample: non-institutionalised people aged 65 years or older
Interventions | 1. 800 IU of vitamin D and 1000 mg of calcium will be administered daily 2. Placebo
Outcomes | Number of falls Adverse events Other outcomes not included in this review
Starting date | November 2008 to April 2012
Contact information | Research Unit Primary Care Head Office of Albacete Albacete, Spain, 02001
Notes |

NTR1593
Study name | IMPROveFALL
Methods | RCT (multicentre)
Participants | N = 620 Sample: people aged ≥ 65 years who visit the Emergency Department due to a fall Inclusion criteria: history of a fall; using at least 1 fall-risk increasing drug; community-dwelling; aged ≥ 65 years; independently ambulant; informed consent Exclusion criteria: cognitively impaired (MMSE < 21 points)
Interventions | 1. Structured medication assessment including withdrawal of fall-risk increasing drugs 2. Usual care All patients receive a full geriatric assessment at the research outpatient clinic
Outcomes | Number of falls Economic evaluation
Starting date | October 2008. Planned closing date October 2011
Contact information | Dr TJM Van der Cammen Department of Internal Medicine - Section Geriatric Medicine Erasmus Medical Centre P.O. Box 2040 3000 CA Rotterdam The Netherlands Email: t.vandercammen@erasmusmc.nl
Notes |

## Footnotes

3MS: modified mini-mental state examination (cognitive assessment)
A&E: accident and emergency department
ADL: activities of daily living
ANZCTR: Australian New Zealand Clinical Trials Registry
BMI: body mass index
BP: blood pressure
bpm: beats per minute
ChEI: cholinesterase inhibitors
COPD: chronic obstructive pulmonary disease
ED: emergency department
GP: general practitioner
IADL: instrumental activities of daily living, e.g. use of telephone, shopping, housework, managing finances
MMSE: mini-mental state examination (cognitive assessment)
O&M: orientation and mobility
OT: occupational therapy
p.o.: orally
PPA: Physiological Profile Assessment
RCT: randomised controlled trial
SPPB: Short Physical Performance Battery

## References to studies

### ACTRN012606000023550 {published data only}

- ACTRN12606000023550 . Healthy Steps: A trial of pedometer-based Green Prescription to improve physical activity, health-related quality of life, and health and physical functioning in low-active older adults. www.anzctr.org.au/trial_view.aspx?ID=996 (accessed 2 September 2011).
- Kolt GS , Schofield GM , Kerse N , Garrett N , Schluter PJ , Ashton T , et al. The healthy steps study: a randomized controlled trial of a pedometer-based green prescription for older adults. Trial protocol. BMC Public Health 2009;9:404.

### ACTRN12607000017426 {published data only}

- ACTRN12607000017426 . A randomised controlled trial on improving gait speed and other health outcomes for elderly patients with hip fracture using an individualised nutrition and exercise program. www.anzctr.org.au/trial_view.aspx?ID=81735 (accessed 2 September 2011).
- Thomas SK , Humphreys KJ , Miller MD , Cameron ID , Whitehead C , Kurrle S , et al. Individual nutrition therapy and exercise regime: a controlled trial of injured, vulnerable elderly (INTERACTIVE trial). BMC Geriatrics 2008;8:4. [MEDLINE: 18302787 ]

### ACTRN12607000018415 {published data only}

- ACTRN12607000018415 . An evaluation of the Accident Compensation Corporation (ACC) Tai Chi programme in older adults: does it reduce falls. www.anzctr.org.au/trial_view.aspx?ID=1475 (accessed 11 August 2011).
- Waters DL , Hale L , Grant AM , Herbison P , Goulding A . Osteoporosis and gait and balance disturbances in older sarcopenic obese New Zealanders. Osteoporosis International 2010;21(2):351-7. [MEDLINE: 19436938]

### ACTRN12607000206426 {published data only}

- ACTRN12607000206426 . Community care and hospital based collaborative falls prevention project. www.anzctr.org.au/trial_view.aspx?ID=81955 (accessed 30 November 2011).

### ACTRN12607000563460 {published data only}

- ACTRN12607000563460 . Minimising disability and falls in older people through a post-hospital individualised exercise program. www.anzctr.org.au/trial_view.aspx?ID=82384 (accessed 2 September 2011).
- Sherrington C , Lord SR , Vogler CM , Close JC , Howard K , Dean CM , et al. Minimising disability and falls in older people through a post-hospital exercise program: a protocol for a randomised controlled trial and economic evaluation. BMC Geriatrics 2009;9:8. [MEDLINE: 19245697]

### ACTRN12610000576022 {published data only}

- ACTRN12610000576022 . A comparison on the effectiveness of a novel intervention programme against a traditional supervised exercise programme in improving the fall efficacy in the moderate frail population aged 60 and above. www.anzctr.org.au/trial_view.aspx?ID=335721 (accessed 31 July 2011).
- Kwok BC , Mamun K , Chandran M , Wong CH . Evaluation of the Frails' Fall Efficacy by Comparing Treatments (EFFECT) on reducing fall and fear of fall in moderately frail older adults: study protocol for a randomised control trial. Trials 2011;12:155.

### ACTRN12610000805077 {published data only}

- ACTRN12610000805077 . RESTORE: Recovery exercises and Stepping On after fracture. www.anzctr.org.au/trial_view.aspx?ID=335781 (accessed 28 March 2012).

### ACTRN12610000838011 {published data only}

- ACTRN12610000838011 . In community-dwelling older people who have fallen, does the provision of falls prevention interventions and osteoporosis treatment through a specialist Falls and Bone service prevent more falls than care coordinated by General Practitioners. www.anzctr.org.au/trial_view.aspx?ID=335807 (accessed 30 November 2011).

### Ferrer 2010 {published data only}

- Ferrer A , Badia T , Formiga F , Almeda J , Fernandez C , Pujol R . Gender differences in health status in a population of over 85 year-olds. The Octabaix study [Diferencias de genero en el perfil de salud de una cohorte de 85 anos. Estudio Octabaix]. Atencion Primaria 2011;43(11):577-84. [EMBASE: 2011609254]
- * Ferrer A , Badia T , Formiga F , Gil A , Padros G , Sarro M , et al. A randomized clinical trial of falls and malnutrition prevention in community-dwelling elders aged 85 years old. The OCTABAIX study [Ensayo clinico aleatorizado de prevencion de caidas y malnutricion en personas de 85 anos en la comunidad. Estudio OCTABAIX]. Revista Espanola de Geriatria y Gerontologia 2010;45(2):79-85.

### ISRCTN10538608 {published data only}

[ISRCTN: 10538608]

- ISRCTN10538608 . SAFER (Support and Assessment for Fall Emergency Referrals) Trial: Evaluation of the costs and benefits of computerised on-scene decision support for emergency ambulance personnel to assess and plan appropriate care for older people who have fallen: a randomised controlled trial. www.controlled-trials.com/ISRCTN10538608 (accessed 2 September 2011).
- Snooks H , Cheung WY , Close J , Dale J , Gaze S , Humphreys I , et al. Support and Assessment for Fall Emergency Referrals (SAFER 1) trial protocol. Computerised on-scene decision support for emergency ambulance staff to assess and plan care for older people who have fallen: evaluation of costs and benefits using a pragmatic cluster randomised trial. BMC Emergency Medicine 2010;10:2.
- Thomas G , Sanchez A , Snooks H . Before the fall: A discussion paper on the organisational difficulties of setting up complex randomised control trials in emergency pre-hospital care [abstract]. Emergency Medicine Journal 2011;28(3):2.

### ISRCTN11861569 {published data only}

[ISRCTN: 11861569]

- ISRCTN11861569 . Falls prevention for frail older adults: Cost-efficacy analysis of balance training based on Tai Chi. www.controlled-trials.com/ISRCTN11861569 (accessed 19 September 2008).
- * Tousignant M , Corriveau H , Roy PM , Desrosiers J , Dubec N , Hébert R , et al. The effect of supervised Tai Chi intervention compared to a physiotherapy program on fall-related clinical outcomes: a randomized clinical trial. Disability & Rehabilitation 2012;34(3):196-201. [MEDLINE: 21958377]
- Tousignant M . personal communication 08 August 2011.

### ISRCTN43453770 {published data only}

[ISRCTN: 43453770]

- * Iliffe S , Kendrick D , Morris R , Skelton D , Gage H , Dinan S , et al. Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial. Trials 2010;11(1):6. [MEDLINE: 20082696]
- ISRCTN43453770 . Promoting physical activity in people aged 65+. www.controlled-trials.com/ISRCTN43453770 (accessed 19 July 2010).
- Perry L , Kendrick D , Morris R , Dinan S , Masud T , Skelton D , et al. Completion and return of fall diaries varies with participants' level of education, first language, and baseline fall risk. Journals of Gerontology Series A-Biological Sciences & Medical Sciences 2012;67(2):210-4.

### ISRCTN48015966 {published data only}

[ISRCTN: 48015966]

- ISRCTN48015966 . The Chaos Clinic for prevention of falls and related injuries: a randomised, controlled trial. www.controlled-trials.com/ISRCTN48015966 (accessed 2 September 2011).

### ISRCTN57066881 {published data only}

[ISRCTN: 57066881]

- Clegg A , Barber S , Young J , Forster A , Iliffe S . The Home-Based Older People's Exercise (HOPE) trial: Study protocol for a randomised controlled trial. Trials 2011;12:Article number 143.
- ISRCTN57066881 . The Home-based Older People's Exercise (HOPE) programme: an exercise programme to improve the functional status of older people. www.controlled-trials.com/ISRCTN57066881 (accessed 2 September 2011).

### ISRCTN60481756 {published data only}

[ISRCTN: 60481756]

- Care of older people who fall: evaluation of the clinical and cost effectiveness of new protocols for emergency ambulance personnel to assess and refer to appropriate community based care. www.hta.ac.uk/1802 (accessed 2 May 2011).
- Gaze S . SAFER 2: Support and assessment for fall emergency referrals (part of the SAFER research programme [abstract]. Emergency Medicine Journal 2011;28(3):3.
- ISRCTN60481756 . Care of older people who fall: evaluation of the clinical and cost effectiveness of new protocols for emergency ambulance personnel to assess and refer to appropriate community based care - a cluster randomised controlled trial. www.controlled-trials.com/ISRCTN60481756 (accessed 2 May 2011).

### ISRCTN68240461 {published data only}

[ISRCTN: 68240461]

- ISRCTN68240461 . Multifaceted podiatry intervention for fall prevention in patients over 70 years of age. www.controlled-trials.com/ISRCTN68240461 (accessed 2 September 2011).

### ISRCTN71002650 {published data only}

[ISRCTN: 71002650]

- ISRCTN71002650 . Prevention of Fall Injury Trial: a parallel group cluster randomised controlled trial and economic evaluation. www.controlled-trials.com/ISRCTN71002650 (accessed 22 Sept 2010).
- Lamb S . Prevention of fall related injuries trial (Pre-FIT). www.hta.ac.uk/2146 (accessed 22 Sept 2010).

### NCT00413933 {published data only}

[CTG: NCT00413933]

- NCT00413933 . Comprehensive intervention for falls prevention in the elderly. clinicaltrials.gov/show/NCT00413933 (accessed 31 March 2008).

### NCT00483275 {published data only}

[CTG: NCT00483275]

- NCT00483275 . Fall prevention by alfacalcidol and training (SPALT). clinicaltrials.gov/show/NCT00483275 (accessed 23 February 2011).

### NCT00934531 {published data only}

[CTG: NCT00934531]

- Montero-Odasso M , Wells JL , Borrie MJ , Speechley M . Can cognitive enhancers reduce the risk of falls in older people with mild cognitive impairment? A protocol for a randomised controlled double blind trial. BMC Neurology 2009;9:42.
- NCT00934531 . Donepezil and the risk of falls in seniors with cognitive impairment. clinicaltrials.gov/show/NCT00934531 (accessed 31 August 2011).

### NCT00946062 {published data only}

[CTG: NCT00946062]

- NCT00946062 . Evaluation of a standardised orientation and mobility training in older adults with low vision. clinicaltrials.gov/show/NCT00946062 (accessed 31 August 2011).
- Zijlstra GA , van Rens GH , Scherder EJ , Brouwer DM , van der V , Verstraten PF , et al. Effects and feasibility of a standardised orientation and mobility training in using an identification cane for older adults with low vision: design of a randomised controlled trial. BMC Health Services Research 2009;9:153.

### NCT00986466 {published data only}

[CTG: NCT00986466]

- NCT00986466 . Vitamin D and exercise in falls prevention (DEX). clinicaltrials.gov/show/NCT00986466 (accessed 31 August 2011).

### NCT01029171 {published data only}

[CTG: NCT01029171]

- Donaldson MG , Khan KM , Sobolev B , Janssen P , Cook WL , McKay HA . Action Seniors!: An RCT of the Otago Home Exercise Program to ameliorate fall risk factor profile in patients at high risk of falls [abstract]. Annual Meeting of the American Society for Bone and Mineral Research; 2007 Sept 16-20; Honolulu (Hawaii).
- NCT01029171 . Action Seniors! Exercise to prevent falls. clinicaltrials.gov/show/NCT01029171 (accessed 31 August 2011).

### NCT01032252 {published data only}

[CTG: NCT01032252]

- Blank WA , Freiberger E , Siegrist M , Landendoerfer P , Linde K , Schuster T , et al. An interdisciplinary intervention to prevent falls in community-dwelling elderly persons: protocol of a cluster-randomized trial [PreFalls]. BMC Geriatrics 2011;11:7. [MEDLINE: 21329525]
- NCT01032252 . Prevention of falls in general practitioner for community-dwelling older adults [PreFalls]. clinicaltrials.gov/show/NCT01032252 (accessed August 2011).

### NCT01080196 {published data only}

[CTG: NCT01080196]

- NCT01080196 . Reducing falls with RENEW in older adults who have fallen. clinicaltrials.gov/show/NCT01080196 (accessed 31 August 2011).

### NCT01358032 {published data only}

[CTG: NCT01358032]

- Dorresteijn TA , Zijlstra GA , Delbaere K , van Rossum E , Vlaeyen JW , Kempen GI . Evaluating an in-home multicomponent cognitive behavioural programme to manage concerns about falls and associated activity avoidance in frail community-dwelling older people: Design of a randomised control trial [NCT01358032]. BMC Health Services Research 2011;11:228.
- NCT01358032 . Evaluating an in-home multicomponent program to manage concerns about falling in frail community dwelling older people. clinicaltrials.gov/ct2/show/NCT01358032 (accessed 04 March 2012).

### NCT01452243 {published data only}

[CTG: NCT01452243]

- * Lopez-Torres Hidalgo J , ANVITAD Group . Prevention of falls and fractures in old people by administration of calcium and vitamin D. randomized clinical trial. BMC Public Health 2011;11:910.
- NCT01452243 . Prevention of Falls and Fractures in Old People by Administration of Calcium and Vitamin D. Randomized Clinical Trial (ANVITAD). clinicaltrials.gov/ct2/show/NCT01452243 (accessed 14 March 2012).

### NTR1593 {published data only}

- Hartholt KA , Van Der Velde N , van Lieshout EM , Polinder S , de Vries OJ , Boye ND , et al. [Cost]effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study). BMC Geriatrics 2011;11:48.
- NTR1593 . Research into prevention of medication induced fall incidents. www.trialregister.nl/trialreg/admin/rctview.asp?TC=1593 (accessed 05 March 2012).