Accidental FallsOsséboNCT00545350
Exercise Intervention to Prevent Fall-related Fractures and Other Injuries : The Ossébo Study
A study testing Fall prevention exercise program in people with Accidental Falls and Fractures, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 75 to 90 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Fractures, Fall-related Injuries
- What is being tested?
- Fall prevention exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 20 sitesFrance
- Study dates
- Nov 2007to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 90 years
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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).
Who cannot join
- serious health problems preventing practice of a physical activity (medical contra-indications),
- already engaged in fall prevention or general group exercise classes.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Centre de Recherche Clinique, CHU Amiens Sud
Amiens, 80054
Centre d'Examen et de Santé (CPAM)
Annecy, 74000
Clinique Les Abondances
Boulogne-Billancourt, 92
Centre Hospitalier Universitaire
Caen, 14000
Hôpital Corentin Celton
Issy-les-Moulineaux, 92130
Hôpital gériatrique les Bateliers
Lille, 59037
Centre Régional de Prévention
Lyon, 69007
Centre de Prévention et de Traitement des Maladies du Vieillissement, CHRU Montpellier
Montpellier, 34295
Hôpital Bellier (CHU)
Nantes, 44000
Centre d'Examens de Santé (CPAM)
Nîmes, 30000
Hôpital Tenon
Paris, Paris, 75020
Hôpital La Collégiale
Paris, 75005
Centre de Gérontologie Sainte Périne
Paris, 75016
Observatoire de l'âge
Paris, 75017
Hôpital Bretonneau
Paris, 75018
Centre Marnais de Promotion de la Santé
Reims, 51100
Centre Hospitalier Universitaire Charles Nicolle
Rouen, 76000
Hôpital de La Charité
Saint-Etienne, 42000
Hôpital de la Robertsau
Strasbourg, 67091
Hôpital Paul Brousse
Villejuif, 94807
About this study
Official title: Randomized Controlled Trial of Prevention of Fall-related Fractures and Other Injuries by Physical Exercise Among Community Dwelling Elderly Women
- Primary objective: to evaluate the effectiveness of a fall prevention exercise program in preventing falls resulting in fractures and other physical traumas.
- 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.
Read the detailed description
Background : Osteoporotic fractures are a major cause of morbidity and disability in elderly women. Most of these fractures result from a fall. Falls prevention measures largely applicable in the population may contribute to significantly reduce the number of fractures in the population. Recent randomized controlled trials have shown that exercise programs of relatively low intensity, but centered on balance retraining and targeted to subjects at moderate risk, can reduce the risk of falls by 30% in community-dwelling elderly people (Province MA et al 1995 ; Gillepsie LD et al 2003 ; Chang JT et al 2004). But, the effectiveness of exercise in preventing injuries caused by falls, in particular the most serious ones such as those accompanied by fractures, has not been demonstrated. Most previous trials are underpowered to examine the effect of fall prevention exercise programmes on severe injurious falls. Furthermore, there is no consensus about the outcomes of fall related injuries that should be evaluated in controlled trials, and the injurious falls definitions vary substantially across studies. Besides falls leading to fractures and other serious injuries, falls leading to medical care use ought to be considered as well, since their cost for society is high and their burden on the health care system heavy. Falls causing minor injuries are also important, as they may also have serious consequences, such as depression, fear of falling, and activity restriction.
Objectives : To evaluate the effectiveness of exercise in preventing falls resulting in fractures or other physical traumas. Also, to better understand the mechanisms by which physical exercise prevents injurious falls (e.g., improvement in physical functional abilities, global physical activity level, general physical and mental health, and self-confidence), and to determine the individual factors associated with a good long-term adherence to the program.
Method : Randomized controlled trial. Participants will be women aged 75 to 85 years old, living at home, but with impaired physical functional capacity (as assessed by simple functional tests). Women will be recruited using general population lists, such as voter-registration or supplemental health-insurance membership rolls. They will be randomized in 2 groups : one that will receive the intervention, and a control group without it. Each group will include 1000 women followed for 2 years, which will allow to demonstrate a 30% reduction in the frequency of serious falls in the intervention group (if the incidence of serious falls is around 8% per year). Falls and injuries occurrence will be monitored by asking women to return monthly calendar cards where they can mark the date of any falls. A telephone interview will then be realized in case a fall is reported to record the circumstances and consequences of the fall.
Intervention : The intervention will last 2 years and will be implemented in partnership with the association SIEL (Sport, Initiatives, et Loisir) Bleu in 20 study centers located in large and medium-sized cities. It will include weekly 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.
Evaluation criteria : The main outcome measure will be the incidence of serious falls defined as " an unexpected event in which the participant comes to rest on the ground, floor, or lower level " and accompanied by a fracture or another serious injury (including head injuries requiring hospitalization, joint dislocations, severe sprains, other non-specified serious joint injuries, and lacerations requiring suturing) (Buchner DM et al 1993). The effectiveness of the intervention on 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 (Campbell AJ et al 1997) will also be assessed. Falls associated with an intrinsic major event or an overwhelming hazard (e.g., traffic accident) will be excluded. Intermediate outcome measures, which may help to explain the effect (or absence of effect) of the intervention, will be changes in physical functional capacity (e.g., balance, gait), global physical activity level, feeling of self-efficacy (fear of falling), and general physical and psychological well-being (quality of life). These changes will be evaluated on a sample of participants (160 per group) that will be re-examined at 1 year and 2 years.
Expected results : The group intervention that we propose to assess is relatively simple to implement. It relies on a network of physical exercise instructors already established across France. In case of a demonstrated benefit it could therefore be easily generalized as part of a population-based public health program of fall-related injuries prevention in the elderly. The intervention should enable elderly women to preserve two elements essential to their quality of life as they age, that is, their functional capacity and their independence.
- Conditions
- Accidental Falls, Fractures, Fall-related Injuries
- Being tested
- Fall prevention exercise program
- Keywords
- Prevention, Falls, accidental falls, Fractures, Physical injuries, Women, Elderly, Physical exercise, Balance exercise
- Medical subject headings
- Fractures, Bone, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fall prevention exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Fall prevention exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 1 year and 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Patricia Dargent-Molina, PhD, Principal investigator, Institut National de la Santé et de la Recherche Médicale, 94800 VillejuifBernard Cassou, MD, PhD, Principal investigator, Université Versailles-Saint Quentin, AP-HP, Hôpital Sainte Périne, 75016, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545350
- Sponsor's protocol ID
- AOM06076, K060209
- Other IDs
- ANR 06BLAN009001,, 047/06-DAS (INPES), 0900342
- Acronym
- Ossébo
- Status last verified
- May 2012
- First submitted
- 16 Oct 2007
- Last updated
- 3 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15031239Buchner 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.
PubMed 9224433Campbell 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.
PubMed 9366737Campbell 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.
PubMed 10604501Robertson 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.
PubMed 11264206Lord 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.
PubMed 14687345Barnett 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.
PubMed 12851185Day 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.
PubMed 12130606Li 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.
PubMed 15814861Gillespie 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.
PubMed 14583918Province 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.
PubMed 7715058Lord 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.
PubMed 16078954Tinetti 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.
PubMed 8078528Robertson 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.
PubMed 12028179Kannus 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.
PubMed 16310556
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Prevention of Fall-related Fractures and Other Injuries by Physical Exercise Among Community Dwelling Elderly Women
- ClinicalTrials.gov ID
- NCT00545350
- Acronym / sponsor ID
- Ossébo / AOM06076, K060209
- Conditions
- Accidental Falls, Fractures, Fall-related Injuries
- Keywords
- Prevention, Falls, accidental falls, Fractures, Physical injuries, Women, Elderly, Physical exercise, Balance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- 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
- Study start
- Nov 2007
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Primary objective: to evaluate the effectiveness of a fall prevention exercise program in preventing falls resulting in fractures and other physical traumas.
- 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.
Detailed description
Background : Osteoporotic fractures are a major cause of morbidity and disability in elderly women. Most of these fractures result from a fall. Falls prevention measures largely applicable in the population may contribute to significantly reduce the number of fractures in the population. Recent randomized controlled trials have shown that exercise programs of relatively low intensity, but centered on balance retraining and targeted to subjects at moderate risk, can reduce the risk of falls by 30% in community-dwelling elderly people (Province MA et al 1995 ; Gillepsie LD et al 2003 ; Chang JT et al 2004). But, the effectiveness of exercise in preventing injuries caused by falls, in particular the most serious ones such as those accompanied by fractures, has not been demonstrated. Most previous trials are underpowered to examine the effect of fall prevention exercise programmes on severe injurious falls. Furthermore, there is no consensus about the outcomes of fall related injuries that should be evaluated in controlled trials, and the injurious falls definitions vary substantially across studies. Besides falls leading to fractures and other serious injuries, falls leading to medical care use ought to be considered as well, since their cost for society is high and their burden on the health care system heavy. Falls causing minor injuries are also important, as they may also have serious consequences, such as depression, fear of falling, and activity restriction.
Objectives : To evaluate the effectiveness of exercise in preventing falls resulting in fractures or other physical traumas. Also, to better understand the mechanisms by which physical exercise prevents injurious falls (e.g., improvement in physical functional abilities, global physical activity level, general physical and mental health, and self-confidence), and to determine the individual factors associated with a good long-term adherence to the program.
Method : Randomized controlled trial. Participants will be women aged 75 to 85 years old, living at home, but with impaired physical functional capacity (as assessed by simple functional tests). Women will be recruited using general population lists, such as voter-registration or supplemental health-insurance membership rolls. They will be randomized in 2 groups : one that will receive the intervention, and a control group without it. Each group will include 1000 women followed for 2 years, which will allow to demonstrate a 30% reduction in the frequency of serious falls in the intervention group (if the incidence of serious falls is around 8% per year). Falls and injuries occurrence will be monitored by asking women to return monthly calendar cards where they can mark the date of any falls. A telephone interview will then be realized in case a fall is reported to record the circumstances and consequences of the fall.
Intervention : The intervention will last 2 years and will be implemented in partnership with the association SIEL (Sport, Initiatives, et Loisir) Bleu in 20 study centers located in large and medium-sized cities. It will include weekly 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.
Evaluation criteria : The main outcome measure will be the incidence of serious falls defined as " an unexpected event in which the participant comes to rest on the ground, floor, or lower level " and accompanied by a fracture or another serious injury (including head injuries requiring hospitalization, joint dislocations, severe sprains, other non-specified serious joint injuries, and lacerations requiring suturing) (Buchner DM et al 1993). The effectiveness of the intervention on 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 (Campbell AJ et al 1997) will also be assessed. Falls associated with an intrinsic major event or an overwhelming hazard (e.g., traffic accident) will be excluded. Intermediate outcome measures, which may help to explain the effect (or absence of effect) of the intervention, will be changes in physical functional capacity (e.g., balance, gait), global physical activity level, feeling of self-efficacy (fear of falling), and general physical and psychological well-being (quality of life). These changes will be evaluated on a sample of participants (160 per group) that will be re-examined at 1 year and 2 years.
Expected results : The group intervention that we propose to assess is relatively simple to implement. It relies on a network of physical exercise instructors already established across France. In case of a demonstrated benefit it could therefore be easily generalized as part of a population-based public health program of fall-related injuries prevention in the elderly. The intervention should enable elderly women to preserve two elements essential to their quality of life as they age, that is, their functional capacity and their independence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual activity / care |
| 2 | Experimental | Other: Fall prevention exercise programPhysical 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. |
Who may qualify
- Ages
- 75 to 90 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- serious health problems preventing practice of a physical activity (medical contra-indications),
- already engaged in fall prevention or general group exercise classes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fall prevention exercise programWeekly 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 | 2 |
Primary outcome
Incidence of serious fall-related injuries and of all injurious falls including those leading to more moderate injuries
Time frame: 2 years
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).
1 secondary outcome
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)
Time frame: 1 year and 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
- Background: PubMed 15031239Chang 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.
- Background: PubMed 9224433Buchner 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.
- Background: PubMed 9366737Campbell 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.
- Background: PubMed 10604501Campbell 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.
- Background: PubMed 11264206Robertson 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.
- Background: PubMed 14687345Lord 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.
- Background: PubMed 12851185Barnett 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.
- Background: PubMed 12130606Day 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.
- Background: PubMed 15814861Li 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.
- Background: PubMed 14583918Gillespie 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.
- Background: PubMed 7715058Province 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.
- Background: PubMed 16078954Lord 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Dargent-Molina, PhD principal investigator
Institut National de la Santé et de la Recherche Médicale, 94800 Villejuif
Bernard Cassou, MD, PhD principal investigator
Université Versailles-Saint Quentin, AP-HP, Hôpital Sainte Périne, 75016, Paris
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fall prevention exercise program in people with Accidental Falls and Fractures, run by Assistance Publique - Hôpitaux de Paris at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious fall-related injuries and of all injurious falls including those leading to more moderate injuries (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00545350, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.