Accidental Falls Clinical Trial
— OsséboOfficial title:
Randomized Controlled Trial of Prevention of Fall-related Fractures and Other Injuries by Physical Exercise Among Community Dwelling Elderly Women
Verified date | May 2012 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
1. Primary objective: to evaluate the effectiveness of a fall prevention exercise program
in preventing falls resulting in fractures and other physical traumas.
2. Secondary objectives:
- to better understand the mechanisms by which physical exercise prevents falls and
ensuing injuries (improvement in physical functional abilities, global physical
activity level, general physical and psychological wellbeing and self-confidence).
- to determine the individual factors associated with long-term adherence to the
exercise program.
Status | Completed |
Enrollment | 706 |
Est. completion date | June 2013 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 75 Years to 90 Years |
Eligibility |
Inclusion Criteria: - women aged 75 years and older, - living at home but with impaired physical functional capacity (as assessed by simple functional tests: 6-meter walking test and tandem walk test). Exclusion Criteria: - serious health problems preventing practice of a physical activity (medical contra-indications), - already engaged in fall prevention or general group exercise classes. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
France | Centre de Recherche Clinique, CHU Amiens Sud | Amiens | |
France | Centre d'Examen et de Santé (CPAM) | Annecy | |
France | Clinique Les Abondances | Boulogne-Billancourt | |
France | Centre Hospitalier Universitaire | Caen | |
France | Hôpital Corentin Celton | Issy-les-moulineaux | |
France | Hôpital gériatrique les Bateliers | Lille | |
France | Centre Régional de Prévention | Lyon | |
France | Centre de Prévention et de Traitement des Maladies du Vieillissement, CHRU Montpellier | Montpellier | |
France | Hôpital Bellier (CHU) | Nantes | |
France | Centre d'Examens de Santé (CPAM) | Nimes | |
France | Centre de Gérontologie Sainte Périne | Paris | |
France | Hôpital Bretonneau | Paris | |
France | Hôpital La Collégiale | Paris | |
France | Hôpital Tenon | Paris | |
France | Observatoire de l'âge | Paris | |
France | Centre Marnais de Promotion de la Santé | Reims | |
France | Centre Hospitalier Universitaire Charles Nicolle | Rouen | |
France | Hôpital de La Charité | Saint-etienne | |
France | Hôpital de la Robertsau | Strasbourg | |
France | Hôpital Paul Brousse | Villejuif |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Institut National de la Santé Et de la Recherche Médicale, France, Institut national de prevention et d'education pour la sante, Partenariats institutions-citoyens pour la recherche et l'innovation, Région Ile de France |
France,
Barnett A, Smith B, Lord SR, Williams M, Baumand A. Community-based group exercise improves balance and reduces falls in at-risk older people: a randomised controlled trial. Age Ageing. 2003 Jul;32(4):407-14. — View Citation
Buchner DM, Cress ME, de Lateur BJ, Esselman PC, Margherita AJ, Price R, Wagner EH. The effect of strength and endurance training on gait, balance, fall risk, and health services use in community-living older adults. J Gerontol A Biol Sci Med Sci. 1997 Jul;52(4):M218-24. — View Citation
Buchner DM, Hornbrook MC, Kutner NG, Tinetti ME, Ory MG, Mulrow CD, Schechtman KB, Gerety MB, Fiatarone MA, Wolf SL, et al. Development of the common data base for the FICSIT trials. J Am Geriatr Soc. 1993 Mar;41(3):297-308. — View Citation
Campbell AJ, Robertson MC, Gardner MM, Norton RN, Buchner DM. Falls prevention over 2 years: a randomized controlled trial in women 80 years and older. Age Ageing. 1999 Oct;28(6):513-8. — View Citation
Campbell AJ, Robertson MC, Gardner MM, Norton RN, Tilyard MW, Buchner DM. Randomised controlled trial of a general practice programme of home based exercise to prevent falls in elderly women. BMJ. 1997 Oct 25;315(7115):1065-9. — View Citation
Chang JT, Morton SC, Rubenstein LZ, Mojica WA, Maglione M, Suttorp MJ, Roth EA, Shekelle PG. Interventions for the prevention of falls in older adults: systematic review and meta-analysis of randomised clinical trials. BMJ. 2004 Mar 20;328(7441):680. Review. — View Citation
Day L, Fildes B, Gordon I, Fitzharris M, Flamer H, Lord S. Randomised factorial trial of falls prevention among older people living in their own homes. BMJ. 2002 Jul 20;325(7356):128. — View Citation
Gillespie LD, Gillespie WJ, Robertson MC, Lamb SE, Cumming RG, Rowe BH. Interventions for preventing falls in elderly people. Cochrane Database Syst Rev. 2003;(4):CD000340. Review. Update in: Cochrane Database Syst Rev. 2009;(2):CD000340. — View Citation
Kannus P, Sievänen H, Palvanen M, Järvinen T, Parkkari J. Prevention of falls and consequent injuries in elderly people. Lancet. 2005 Nov 26;366(9500):1885-93. Review. — View Citation
Li F, Harmer P, Fisher KJ, McAuley E, Chaumeton N, Eckstrom E, Wilson NL. Tai Chi and fall reductions in older adults: a randomized controlled trial. J Gerontol A Biol Sci Med Sci. 2005 Feb;60(2):187-94. — View Citation
Lord SR, Castell S, Corcoran J, Dayhew J, Matters B, Shan A, Williams P. The effect of group exercise on physical functioning and falls in frail older people living in retirement villages: a randomized, controlled trial. J Am Geriatr Soc. 2003 Dec;51(12):1685-92. — View Citation
Lord SR, Tiedemann A, Chapman K, Munro B, Murray SM, Gerontology M, Ther GR, Sherrington C. The effect of an individualized fall prevention program on fall risk and falls in older people: a randomized, controlled trial. J Am Geriatr Soc. 2005 Aug;53(8):1296-304. — View Citation
Province MA, Hadley EC, Hornbrook MC, Lipsitz LA, Miller JP, Mulrow CD, Ory MG, Sattin RW, Tinetti ME, Wolf SL. The effects of exercise on falls in elderly patients. A preplanned meta-analysis of the FICSIT Trials. Frailty and Injuries: Cooperative Studies of Intervention Techniques. JAMA. 1995 May 3;273(17):1341-7. — View Citation
Robertson MC, Campbell AJ, Gardner MM, Devlin N. Preventing injuries in older people by preventing falls: a meta-analysis of individual-level data. J Am Geriatr Soc. 2002 May;50(5):905-11. — View Citation
Robertson MC, Devlin N, Gardner MM, Campbell AJ. Effectiveness and economic evaluation of a nurse delivered home exercise programme to prevent falls. 1: Randomised controlled trial. BMJ. 2001 Mar 24;322(7288):697-701. — View Citation
Tinetti ME, Baker DI, McAvay G, Claus EB, Garrett P, Gottschalk M, Koch ML, Trainor K, Horwitz RI. A multifactorial intervention to reduce the risk of falling among elderly people living in the community. N Engl J Med. 1994 Sep 29;331(13):821-7. — View Citation
Wolf SL, Barnhart HX, Kutner NG, McNeely E, Coogler C, Xu T. Reducing frailty and falls in older persons: an investigation of Tai Chi and computerized balance training. Atlanta FICSIT Group. Frailty and Injuries: Cooperative Studies of Intervention Techniques. J Am Geriatr Soc. 1996 May;44(5):489-97. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of serious fall-related injuries and of all injurious falls including those leading to more moderate injuries | Incidence of serious fall-related injuries (i.e., falls accompanied by fractures, head injuries requiring hospitalization, joint dislocations, severe sprains, other non-specified serious joint injuries, or lacerations requiring suturing), and of all injurious falls including those leading to more moderate injuries (such as bruises, cuts, abrasions or reduction in physical function for at least 3 days, or if the participant sought medical help). | 2 years | No |
Secondary | Changes in physical functional capacity, global physical activity level, feeling of self-efficacy (fear of falling), and general physical and psychological well-being (quality of life) at 1 year (mid-intervention) and 2 years (end of intervention) | 1 year and 2 years | No |
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