Exercise Intervention to Prevent Fall-related Fractures and Other Injuries : The Ossébo Study (Ossébo)
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|ClinicalTrials.gov Identifier: NCT00545350|
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : April 3, 2014
- Primary objective: to evaluate the effectiveness of a fall prevention exercise program in preventing falls resulting in fractures and other physical traumas.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Accidental Falls Fractures Fall-related Injuries||Other: Fall prevention exercise program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||706 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Trial of Prevention of Fall-related Fractures and Other Injuries by Physical Exercise Among Community Dwelling Elderly Women|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
No Intervention: 1
Usual activity / care
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
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.
- 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).
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00545350
|Principal Investigator:||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|