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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00545350
Recruitment Status : Completed
First Posted : October 17, 2007
Last Update Posted : April 3, 2014
Sponsor:
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
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 706 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: 1
Usual activity / care
Experimental: 2

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.





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  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) [ Time Frame: 1 year and 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Locations
Show Show 20 study locations
Sponsors and Collaborators
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
Investigators
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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
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00545350    
Other Study ID Numbers: AOM06076, K060209
ANR 06BLAN009001,
047/06-DAS (INPES)
0900342 ( Other Identifier: PICRI (Région Ile de France) )
First Posted: October 17, 2007    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: May 2012
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Prevention
Falls, accidental falls
Fractures
Physical injuries
Women
Elderly
Physical exercise
Balance exercise
Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries