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11 February 2012
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| [ Print-friendly version ] |
| Interventions to prevent falls and injury in elderly people with impaired vision |
| ISRCTN | ISRCTN15342873 |
| ClinicalTrials.gov identifier | |
| Public title | Interventions to prevent falls and injury in elderly people with impaired vision |
| Scientific title | |
| Acronym | VIP Falls Prevention Trial |
| Serial number at source | 02/265 |
| Study hypothesis |
Study objectives:
1. To demonstrate the efficacy of two interventions: 1.1. A strength and balance retraining programme and vitamin D supplements 1.2. A home safety programme, in preventing falls and injuries in people living in the community aged 75 years and over with visual impairment (visual acuity 6/24 or less) 2. To demonstrate the efficacy of the two programmes in improving independence, level of physical activity and quality of life 3. To determine the cost effectiveness of the two interventions in comparison with other falls prevention strategies 4. To determine the vitamin D status in a sample of people 75 years and over with visual impairment and compare this with an age and sex matched control group drawn from the same general practices at the same time Summary of study design: We will assess the effectiveness and cost effectiveness of two falls prevention programmes in a randomised controlled trial with one year of follow up. The two interventions will be individually delivered at home: 1. An exercise programme for one year consisting of a set of leg muscle strengthening and balance retraining exercises and a walking plan, modified for use by visually impaired people and individually prescribed by a physiotherapist. Participants in this intervention arm will also receive vitamin D (Calciferol) supplements. 2. An injury prevention programme of home safety assessment and modification designed specifically for visually impaired people and delivered by an occupational therapist. We will recruit 400 men and women living in the community and aged 75 years and older with visual acuity of 6/24 metres or less. Potential participants will be recruited from low vision clinics at two city hospitals and one university department and from those registered with the Royal New Zealand Foundation for the Blind. The trial has a two by two factorial design. There will be 100 people randomly allocated to each of four groups: 1. The home exercise programme and vitamin D supplements, plus the home safety programme 2. The home exercise programme and vitamin D supplements 3. The home safety programme 4. A control group with no falls prevention intervention who will receive their usual care and health services, plus social visits. Falls, injuries and healthcare resource use as a result of falls will be monitored for one year. |
| Lay summary | |
| Ethics approval | Ethics approval received from Otago and Auckland Ethics Committees. |
| Study design | Randomised controlled trial |
| Countries of recruitment | New Zealand |
| Disease/condition/study domain | Falls in elderly people |
| Participants - inclusion criteria |
1. Community living women and men aged 75 years and older
2. Visual acuity 6/24 metres or less |
| Participants - exclusion criteria |
1. Cannot walk around their own residence
2. Receiving physiotherapy at the time of recruitment 3. Cannot understand the trial requirements |
| Anticipated start date | 01/10/2002 |
| Anticipated end date | 31/10/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 391 |
| Interventions |
1. Home environment programme
2. Home exercise programme 3. Both home environment and exercise programmes 4. Social visits |
| Primary outcome measure(s) | Falls and injuries resulting from falls. |
| Secondary outcome measure(s) |
1. Self perceived health status (36-item short form health survey [SF-36])
2. Fear of falling 3. Physical activity level (human activity profile) 4. Visual disability (VF-14) 5. Mobility and physical independence (Nottingham extended activities of daily living [ADL]) 6. Muscle strength and balance (4-test balance scale, chair stand test) 7. Use of health care resources as a result of falls and injuries 8. The incremental costs and cost effectiveness of delivering each intervention (if the intervention is effective in reducing falls) |
| Sources of funding | Health Research Council of New Zealand (New Zealand) (ref: 02/265) |
| Trial website | |
| Publications | Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16183652 |
| Contact name | Prof A John Campbell |
| Address |
Department of Medical and Surgical Sciences
University of Otago Medical School PO Box 913 |
| City/town | Dunedin |
| Zip/Postcode | 9001 |
| Country | New Zealand |
| Tel | +64 (0)3 4747007 ext. 8506 |
| Fax | +64 (0)3 4747641 |
| john.campbell@stonebow.otago.ac.nz | |
| Sponsor | Health Research Council of New Zealand (New Zealand) |
| Address |
PO Box 5541
Wellesley Street |
| City/town | Auckland |
| Zip/Postcode | 1001 |
| Country | New Zealand |
| Tel | +64 (0)9 379 8227 |
| Fax | +64 (0)9 377 9988 |
| info@hrc.govt.nz | |
| Sponsor website: | http://www.hrc.govt.nz/ |
| Date applied | 02/03/2005 |
| Last edited | 20/12/2007 |
| Date ISRCTN assigned | 07/03/2005 |
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