Cochrane

# Supplementary material 4 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 studies awaiting classification

## Table of contents

- Studies ordered by study ID
  - Adunsky 2011
  - Bighea 2011
  - Clemson 2012
  - Freiberger 2012
  - Glendenning 2012
  - Neelemaat 2012
  - Pérula 2012
  - Sach 2012
  - Taylor 2012
- Footnotes
- References to studies

## Studies ordered by study ID

Adunsky 2011
Methods | RCT (multicentre)
Participants | Setting: 8 countries N = 123 Sample: hip fracture patients Inclusion criteria: aged ≥ 60; ambulatory; unilateral hip fracture; non-complicated surgical repair; no more than 4 days after hip fracture; MMSE score ≥ 21 Exclusion criteria: hip fracture due to bone pathology other than osteoporosis, or major trauma, uncontrolled thyroid disease, uncontrolled diabetes, cancer, uncontrolled hypertension; currently receiving systemic corticosteroids (10 mg/day); medications known to affect growth hormone secretion; end organ disease; neuromuscular or neurologic disease causing muscle weakness; recent signs or symptoms of coronary heart disease (during 3 months prior to study); NYHA class-III or IV coronary heart failure (CHF); stroke and carpel tunnel syndrome.
Interventions | 1. MK-0677 (ibutamoren mesylate) 25 mg/day to stimulate secretion of growth hormone 2. Control: placebo All participants received vitamin D3 (400 IU/day)
Outcomes | 1. Number of falls
Duration of the study | Planned duration unclear. Terminated early (24 wks) due to adverse events (congestive heart failure)
Notes | No description of how falls were monitored

Bighea 2011
Methods | RCT
Participants | Setting: Craiova, Romania N = 80 Sample: women with osteoporosis Age: not stated Inclusion criteria: not stated Exclusion criteria: not stated
Interventions | 1. Home-based exercise and balance training programme 2. Control: "just with antiosteoporotic medication and advice on fall prevention"
Outcomes | 1. Number of people falling Other outcomes not included in this review
Duration of the study | 10 months
Notes | Assume these 3 abstracts are interim reports of the same trial, possibly still ongoing. No full report identified and unable to contact authors.

Clemson 2012
Methods | RCT
Participants | Setting: metropolitan Sydney, Australia N = 317 Sample: invited from Veteran's Affairs databases and 3 GP databases Age (years): 83.4 Inclusion criteria: community-dwelling people; aged ≥ 70; history of ≥ 2 falls or 1 injurious fall in past 12 months Exclusion criteria: moderate-severe cognitive impairment; unable to walk independently; neurological condition severely influencing gait and mobility; resident in a nursing home or hostel; any unstable or terminal medical illness precluding planned exercises; no conversational English
Interventions | 1. LiFE (Lifestyle approach to reducing Falls through Exercise) programme (progressive balance and strength training embedded in daily life activities) 2. Structured programme: balance and lower limb strength exercises using ankle cuff weights, performed 3 times a week 3. Control: gentle/sham exercise All interventions taught at home: the 'LiFE' and 'Structured' programmes over 5 sessions with 2 booster visits and 2 phone calls; the control sham/gentle exercise group received 3 home visits and 6 phone calls
Outcomes | 1. Rate of falls 2. Number of people falling Other outcomes not included in this review.
Duration of the study | 1 year
Notes |

Freiberger 2012
Methods | RCT
Participants | Setting: Erlangen, Germany N = 280 Sample: recruited from health insurance company membership database (44% female) Age (years): 76.1 (SD 4.1) Inclusion criteria: community-dwelling adults; aged 70 to 90; fallen in the past 6 months or reported fear of falling Exclusion criteria: unable to ambulate independently; cognitive impairment (< 25 on the Digit Symbol Substitution Test (DSST))
Interventions | 1. "Strength and balance group": strength and balance exercises only 2. "Fitness group": strength and balance plus endurance training 3. "Multifaceted group": strength and balance plus fall risk education 4. Control group The interventions consisted of 32 1-hour group sessions in 16 weeks
Outcomes | Falls and fallers (multiple fallers)
Duration of the study | 3 years
Notes | Previously excluded as 2007 paper was reported as an RCT but control group was not randomised. Number randomised less in 2012 paper which reports 12 to 24-month data.

Glendenning 2012
Methods | RCT
Participants | Setting: Perth, Western Australia N = 686 Sample: women identified from GP lists and electoral rolls Age (years): 76.7 (SD 4.0) Inclusion criteria: aged > 70; registered with a GP; likely to attend 4 study visits over 9 months Exclusion criteria: taking vitamin D supplements; cognitive impairment (MMSE < 24); "in the investigators opinion would not be suitable for the study"
Interventions | 1. Oral vitamin D (cholecalciferol) 150,000 IU administered every 3 months for 9 months + lifestyle advice 2. Control: placebo + lifestyle advice Lifestyle advice: physical activity (optimally 30 min per day outside) and consuming 1300 mg calcium/d using diet and/or supplements
Outcomes | 1. Number of people falling Other outcomes not included in this review
Duration of the study | 9 months
Notes |

Neelemaat 2012
Methods | RCT
Participants | Setting: Amsterdam, The Netherlands N = 210 Sample: malnourished older adults newly admitted to an acute hospital (general internal medicine, rheumatology, gastroenterology, dermatology, nephrology, orthopedics, traumatology, or vascular surgery) Age (years): 74.5 (SD 9.5) Inclusion criteria: aged ≥ 60; expected length of hospital stay > 2 days); malnourished (BMI ≤ 20.0 kg/m2, 5% or more self reported unintentional weight loss in the previous month, or 10% or more self reported unintentional weight loss in the previous 6 months) Exclusion criteria: dementia
Interventions | 1. Nutritional intervention (energy- and protein-enriched diet, oral nutritional supplements, calcium-vitamin D supplement, telephone counselling by a dietitian 2. Control: usual care
Outcomes | Falls monitored for 3 months after discharge
Duration of the study | 3 months post discharge
Notes | Not all community-dwelling, but 88% were prior to admission

Pérula 2012
Methods | RCT (cluster-randomised)
Participants | Setting: 11 health centres in Córdoba, Spain N = 404 Sample: recruited consecutively when attending health centre Age (years): mean 76 (SD 4.2) Inclusion criteria: aged ≥ 70; community-dwelling; able to walk independently; consenting Exclusion criteria: institutionalised; immobilised, or bedridden; terminally ill or severe psychiatric illness and have contraindications to physical exercise
Interventions | 1. Multifactorial intervention (individual advice, information leaflet, physical exercise classes for 3 weeks then home exercise, home visits) 2. Control: brief individual advice and information leaflet
Outcomes | 1. Rate of falls 2. Time to first fall 3. Number of people falling
Duration of the study | 12 months
Notes |

Sach 2012
Methods | Cost-effectiveness and cost-utility analysis alongside an included RCT (Logan 2010)
Participants | Setting: community, UK N = 204 (157 participants (82 interventions and 75 controls) used to perform the economic evaluation) Inclusion criteria: people > 60 years of age; living at home or in residential care; history of a fall and having called an emergency ambulance but were not taken to hospital
Interventions | 1. Referral to community fall prevention services 2. Control: usual health and social care
Outcomes | Incremental cost per fall prevented and incremental cost per QALY
Duration of the study | 1 year
Notes | Not added to Logan 2010 as identified too late for economic data to be included in review

Taylor 2012
Methods | RCT
Participants | Setting: 11 sites throughout New Zealand N = 684 Sample: recruited through newspaper advertisements, local radio and television, posters and flyers in local community centres, doctors’ and physiotherapists’ offices, libraries, and churches (73% women) Age (years): mean 74.5 Inclusion criteria: community-dwelling; aged ≥ 65 (≥ 55 if Maori or Pacific Islander); history of ≥ 1 fall in previous 12 mo or considered to be at risk of falling based on Falls Risk Assessment Tool (FRAT) score ≥ 1; medical clearance for low or moderate exercise programme Exclusion criteria: unable to ambulate independently (with or without walking aid); chronic medical condition limiting low- to moderate-intensity exercising; cognitive impairment (telephone MMSE < 23); participated in Tai Chi within the last year; currently participating in an organised exercise programme aimed at improving strength and balance
Interventions | 1. Tai Chi (modified 10-form Sun style): hour long class 1 x per week for 20 weeks 2. Tai Chi (modified 10-form Sun style): hour long class 2 x per week for 20 weeks 3. Control: low-level exercise class (mainly seated and not targeting strength and balance) 1 x per week for 20 weeks
Outcomes | 1. Rate of falls
Duration of the study | 17 months
Notes |

## Footnotes

BMD: bone mineral density
BMI: body mass index
GP: general practitioner (family physician)
MMSE: Mini Mental State Examination
NYHA: New York Heart Association
RCT: randomised controlled trial

## References to studies

### Adunsky 2011 {published data only}

- Adunsky A , Chandler J , Heyden N , Lutkiewicz J , Scott BB , Berd Y , et al. MK-0677 (ibutamoren mesylate) for the treatment of patients recovering from hip fracture: a multicenter, randomized, placebo-controlled phase IIb study. Archives of Gerontology & Geriatrics 2011;53(2):183-9.

### Bighea 2011 {published data only}

- Bighea A , Patru S , Bumbea A , Popescu R . Randomized controlled trial of a home based exercise and balance training programme in elderly women with osteoporosis [abstract]. Osteoporosis International 2011;22(Suppl 1):S238. [EMBASE: 70393947]
- Bighea AC , Patru S , Marcu IR , Popescu RS . A home based exercise and balance training programme increase physical activity and improves health in women with osteoporosis [abstract]. Osteoporosis International 2010;21:S160. [EMBASE: 70225942]
- Patru S , Bighea AC , Marcu IR , Popescu RS . Randomized controlled trial of exercise fall prevention program in elderly women with osteoporosis [abstract]. Osteoporosis International 2010;21:S347. [EMBASE: 70226355]

### Clemson 2012 {published data only}

- ACTRN12606000025538 . Lifestyle (LIFE) versus structured balance and strength training to reduce falls in the elderly: a randomized trial. www.anzctr.org.au/trial_view.aspx?ID=1007 (accessed 15 June 2012).
- * Clemson L , Fiatarone Singh MA , Bundy A , Cumming RG , Manollaras K , O'Loughlin P , et al. Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial. BMJ 2012;345(7870):Article Number: e4547.

### Freiberger 2012 {published and unpublished data}

- Freiberber E . personal communication October 25 2007.
- * Freiberger E , Haberle L , Spirduso WW , Zijlstra GAR . Long-term effects of three multicomponent exercise interventions on physical performance and fall-related psychological outcomes in community-dwelling older adults: a randomized controlled trial. Journal of the American Geriatrics Society 2012 Feb 10 [Epub ahead of print]. [DOI: https://doi.org/10.1111/j.1532-5415.2011.03859.x]
- Freiberger E , Menz HB , Abu-Omar K , Rutten A . Preventing falls in physically active community-dwelling older people: a comparison of two intervention techniques. Gerontology 2007;53(5):298-305.
- Freiberger E , Menz HB . Characteristics of falls in physically active community-dwelling older people: Findings from the 'Standfest im Alter' study. Zeitschrift fur Gerontologie und Geriatrie 2006;39(4):261-7.
- Freiberger E . personal communication December 12 2007.

### Glendenning 2012 {published data only}

- ACTRN12609000748213 . A randomised controlled placebo-controlled study to evaluate the effects of vitamin D treatment on reducing hospital admissions for falls, fractures and other disorders in elderly women. www.anzctr.org.au/trial_view.aspx?ID=308329 (accessed 11 October 2011).
- * Glendenning P , Zhu K , Inderjeeth C , Howat P , Lewis JR , Prince RL . Effects of three monthly oral 150,000 IU cholecalciferol supplementation on falls, mobility and muscle strength in older postmenopausal women: a randomised controlled trial. Journal of Bone and Mineral Research 2012;27(1):170-6. [DOI: https://doi.org/10.1002/jbmr.5241]

### Neelemaat 2012 {published data only}

- Neelemaat F , Bosmans JE , Thijs A , Seidell JC , Van Bokhorst-De Van Der Schueren MAE . Post-discharge nutritional support in malnourished elderly individuals improves functional limitations. Journal of the American Medical Directors Association 2011;12(4):295-301.
- Neelemaat F , Lips P , Bosmans JE , Thijs A , Seidell JC , Van Bokhorst-De Van Der Schueren MAE . Short-term oral nutritional intervention with protein and vitamin D decreases falls in malnourished older adults. Journal of the American Geriatrics Society 2012 Feb 8 [Epub ahead of print]. [DOI: https://doi.org/10.1111/j.1532-5415.2011.03888.x]
- Neelemaat F , Thijs A , Seidell JC , Bosmans JE , Van Bokhorst-De Van Der Schueren MAE . Study protocol: Cost-effectiveness of transmural nutritional support in malnourished elderly patients in comparison with usual care. Nutrition Journal 2010;9(1):Article number: 6.

### Pérula 2012 {published data only}

- Pérula LA , Varas-Fabra F , Rodríguez V , Ruiz-Moral R , Fernández JA , González J , et al. Effectiveness of a multifactorial intervention program to reduce falls incidence among community-living elderly people: a randomised clinical trial (The EPICA Study). Archives of Physical Medicine and Rehabilitation 2012 May 15 [Epub ahead of print].

### Sach 2012 {published data only}

[ISRCTN: ISRCTN67535605]

- Sach TH , Logan PA , Coupland CA , Gladman JR , Sahota O , Stoner-Hobbs V , et al. Community falls prevention for people who call an emergency ambulance after a fall: aneconomic evaluation alongside a randomised controlled trial. Age and Ageing 2012 June 13 [Epub ahead of print]. [DOI: 10.1093/ageing/afs071 ]

### Taylor 2012 {published data only}

- Taylor D , Hale L , Schluter P , Waters DL , Binns EE , McCracken H , et al. Effectiveness of tai chi as a community-based falls prevention intervention: a randomized controlled trial. Journal of the Americn Geriatrics Society 2012;60(5):841-8.