Exercise Intervention to Prevent Fall-related Fractures and Other Injuries : The Ossébo Study

NCT00545350 | Completed

• 4 other identifiers: AOM06076, K060209ANR 06BLAN009001,047/06-DAS (INPES)0900342
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 20

Brief Summary

• 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.

Conditions

Accidental Falls; Fractures; Fall-related Injuries

Keywords

Prevention; Falls, accidental falls; Fractures; Physical injuries; Women; Elderly; Physical exercise; Balance exercise

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• 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

Study Arms (2)

1

NO INTERVENTION

Usual activity / care

2

EXPERIMENTAL

Physical exercise classes plus home exercises: Weekly physical exercise sessions in small groups, led by a qualified and specially trained instructor, and supplemented by simple exercises to do at home. The exercise program will focus on progressive balance retraining but will also include strength/resistance, coordination and flexibility training exercises.

Other: Fall prevention exercise program

Interventions

Fall prevention exercise program OTHER

Weekly physical exercise sessions in small groups, led by a qualified and specially trained instructor, and supplemented by simple exercises to do at home. The exercise program will focus on progressive balance retraining but will also include strength/resistance, coordination and flexibility training exercises.

2

Eligibility Criteria

• Age: 75 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• serious health problems preventing practice of a physical activity (medical contra-indications),
• already engaged in fall prevention or general group exercise classes.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Institut national de prevention et d'education pour la sante: collaborator
• Partenariats institutions-citoyens pour la recherche et l'innovation, Région Ile de France: collaborator

Study Sites (20)

Hôpital Tenon

Paris, Paris, 75020, France

Location

Centre de Recherche Clinique, CHU Amiens Sud

Amiens, 80054, France

Location

Centre d'Examen et de Santé (CPAM)

Annecy, 74000, France

Location

Clinique Les Abondances

Boulogne-Billancourt, 92, France

Location

Centre Hospitalier Universitaire

Caen, 14000, France

Location

Hôpital Corentin Celton

Issy-les-Moulineaux, 92130, France

Location

Hôpital gériatrique les Bateliers

Lille, 59037, France

Location

Centre Régional de Prévention

Lyon, 69007, France

Location

Centre de Prévention et de Traitement des Maladies du Vieillissement, CHRU Montpellier

Montpellier, 34295, France

Location

Hôpital Bellier (CHU)

Nantes, 44000, France

Location

Centre d'Examens de Santé (CPAM)

Nîmes, 30000, France

Location

Hôpital La Collégiale

Paris, 75005, France

Location

Centre de Gérontologie Sainte Périne

Paris, 75016, France

Location

Observatoire de l'âge

Paris, 75017, France

Location

Hôpital Bretonneau

Paris, 75018, France

Location

Centre Marnais de Promotion de la Santé

Reims, 51100, France

Location

Centre Hospitalier Universitaire Charles Nicolle

Rouen, 76000, France

Location

Hôpital de La Charité

Saint-Etienne, 42000, France

Location

Hôpital de la Robertsau

Strasbourg, 67091, France

Location

Hôpital Paul Brousse

Villejuif, 94807, France

Location

Related Publications (19)

• 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. doi: 10.1136/bmj.328.7441.680.

  PMID: 15031239 BACKGROUND

• 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. doi: 10.1093/gerona/52a.4.m218.

  PMID: 9224433 BACKGROUND

• 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. doi: 10.1136/bmj.315.7115.1065.

  PMID: 9366737 BACKGROUND

• 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. doi: 10.1093/ageing/28.6.513.

  PMID: 10604501 BACKGROUND

• 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. doi: 10.1136/bmj.322.7288.697.

  PMID: 11264206 BACKGROUND

• 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. doi: 10.1046/j.1532-5415.2003.51551.x.

  PMID: 14687345 BACKGROUND

• 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. doi: 10.1093/ageing/32.4.407.

  PMID: 12851185 BACKGROUND

• 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. doi: 10.1136/bmj.325.7356.128.

  PMID: 12130606 BACKGROUND

• 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. doi: 10.1093/gerona/60.2.187.

  PMID: 15814861 BACKGROUND

• 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. doi: 10.1002/14651858.CD000340.

  PMID: 14583918 BACKGROUND

• 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.

  PMID: 7715058 BACKGROUND

• 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. doi: 10.1111/j.1532-5415.2005.53425.x.

  PMID: 16078954 BACKGROUND

• 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. doi: 10.1056/NEJM199409293311301.

  PMID: 8078528 BACKGROUND

• 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. doi: 10.1046/j.1532-5415.2002.50218.x.

  PMID: 12028179 BACKGROUND

• Kannus P, Sievanen H, Palvanen M, Jarvinen T, Parkkari J. Prevention of falls and consequent injuries in elderly people. Lancet. 2005 Nov 26;366(9500):1885-93. doi: 10.1016/S0140-6736(05)67604-0.

  PMID: 16310556 BACKGROUND

• 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. doi: 10.1111/j.1532-5415.1996.tb01432.x.

  PMID: 8617895 BACKGROUND

• 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. doi: 10.1111/j.1532-5415.1993.tb06708.x.

  PMID: 8440854 BACKGROUND

• El-Khoury F, Cassou B, Latouche A, Aegerter P, Charles MA, Dargent-Molina P. Effectiveness of two year balance training programme on prevention of fall induced injuries in at risk women aged 75-85 living in community: Ossebo randomised controlled trial. BMJ. 2015 Jul 22;351:h3830. doi: 10.1136/bmj.h3830.

  PMID: 26201510 DERIVED

• Castro-Lionard K, Dargent-Molina P, Fermanian C, Gonthier R, Cassou B. Use of calcium supplements, vitamin D supplements and specific osteoporosis drugs among French women aged 75-85 years: patterns of use and associated factors. Drugs Aging. 2013 Dec;30(12):1029-38. doi: 10.1007/s40266-013-0121-9.

  PMID: 24114665 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Behavior

Study Officials

• Patricia Dargent-Molina, PhD

  Institut National de la Santé et de la Recherche Médicale, 94800 Villejuif

  PRINCIPAL INVESTIGATOR

• Bernard Cassou, MD, PhD

  Université Versailles-Saint Quentin, AP-HP, Hôpital Sainte Périne, 75016, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2007
• First Posted: October 17, 2007
• Study Start: November 1, 2007
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: April 3, 2014

Record last verified: 2012-05

Locations

FR (20)