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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00545350
First received: October 16, 2007
Last updated: April 2, 2014
Last verified: May 2012
  Purpose
  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 Intervention
Accidental Falls
Fractures
Fall-related Injuries
Other: Fall prevention exercise program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Incidence of serious fall-related injuries and of all injurious falls including those leading to more moderate injuries [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 706
Study Start Date: November 2007
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   75 Years to 90 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545350

Locations
France
Centre de Recherche Clinique, CHU Amiens Sud
Amiens, France, 80054
Centre d'Examen et de Santé (CPAM)
Annecy, France, 74000
Clinique Les Abondances
Boulogne-Billancourt, France, 92
Centre Hospitalier Universitaire
Caen, France, 14000
Hôpital Corentin Celton
Issy-les-moulineaux, France, 92130
Hôpital gériatrique les Bateliers
Lille, France, 59037
Centre Régional de Prévention
Lyon, France, 69007
Centre de Prévention et de Traitement des Maladies du Vieillissement, CHRU Montpellier
Montpellier, France, 34295
Hôpital Bellier (CHU)
Nantes, France, 44000
Centre d'Examens de Santé (CPAM)
Nimes, France, 30000
Hôpital Bretonneau
Paris, France, 75018
Hôpital Tenon
Paris, France, 75020
Hôpital La Collégiale
Paris, France, 75005
Observatoire de l'âge
Paris, France, 75017
Centre de Gérontologie Sainte Périne
Paris, France, 75016
Centre Marnais de Promotion de la Santé
Reims, France, 51100
Centre Hospitalier Universitaire Charles Nicolle
Rouen, France, 76000
Hôpital de La Charité
Saint-etienne, France, 42000
Hôpital de la Robertsau
Strasbourg, France, 67091
Hôpital Paul Brousse
Villejuif, France, 94807
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
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00545350     History of Changes
Other Study ID Numbers: AOM06076, K060209, ANR 06BLAN009001,, 047/06-DAS (INPES), 0900342
Study First Received: October 16, 2007
Last Updated: April 2, 2014
Health Authority: France: Ministry of Health

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:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on August 25, 2014