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Intervention Study of Mind-Body Physical Activity in Frail Institutionalized Elderly

This study has been completed.
Sponsor:
Collaborator:
Conseil Régional d'Aquitaine (France)
Information provided by:
Association de Recherche Gerontologique
ClinicalTrials.gov Identifier:
NCT00623532
First received: February 15, 2008
Last updated: May 18, 2009
Last verified: May 2009
History of Changes
  Purpose

Few previous studies have explored the effects of mind body approaches on health-related quality of life (HRQoL) in frail elderly. Cognition and action are an inseparable whole while functioning. A new intervention-based approach using familiarity based movements and a non-judgmental approach was labeled "cognition-action." The investigators aimed to explore the effects of two different mind-body exercise types on (HRQoL) in frail institutionalized elderly.

The investigators' main hypothesis is that adaptated physical activity in frail institutionalized elderly can improve HRQoL.


Condition Intervention
Aging
Frailty
 Behavioral: Mind-body exercises
Behavioral: Adapted Tai-chi

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Interventional Study of a Cognition-Action Physical Activity and Adapted Tai-Chi in Frail Institutionalized Elderly

Further study details as provided by Association de Recherche Gerontologique:

Primary Outcome Measures:
  • MOS SF-12 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Timed Up and Go test
Enrollment: 160
Study Start Date: May 2006
Study Completion Date: February 2008
Arms Assigned Interventions
Experimental: CA
Cognition and action are an inseparable whole while functioning, a new intervention based approach using familiarity based movements and non judgmental approach was labeled "cognition-action".
 Behavioral: Mind-body exercises
Active Comparator: AT
Adapted Tai Chi is based on Tai Chi like movements
 Behavioral: Adapted Tai-chi
No Intervention: C
Control

  Eligibility
Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 65 and older
  • Institutionalized
  • Ability to get up alone or with technical or human help if necessary and ability to understand basic motor commands
  • Have given a signed consent

Exclusion Criteria:

  • Terminally ill and bedridden patients
  • Unable or unwilling to sign the consent
  • Have participated in a study in the past 3 month
  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: NCT00623532

Locations
France
Hopital Xavier Arnozan, CHU de Bordeaux
Bordeaux, Gironde, France, 33604
Sponsors and Collaborators
Association de Recherche Gerontologique
Conseil Régional d'Aquitaine (France)
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Isabelle Bourdel-Marchasson/ Professor (MD-PhD), Pole of Gerontology-CHU of Bordeaux/ CNRS 5536 University V Segalent Bordeaux 2
ClinicalTrials.gov Identifier: NCT00623532     History of Changes
Other Study ID Numbers: AGR-2006-01-Etude MARGE 
Study First Received: February 15, 2008
Last Updated: May 18, 2009
Health Authority: France: Direction Générale de la Santé
France: French Data Protection Authority
France: Institutional Ethical Committee

Keywords provided by Association de Recherche Gerontologique:
Tertiary prevention of disability

ClinicalTrials.gov processed this record on September 27, 2016