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

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ClinicalTrials.gov Identifier: NCT00623532
Recruitment Status : Completed
First Posted : February 26, 2008
Last Update Posted : May 19, 2009
Sponsor:
Collaborator:
Conseil Régional d'Aquitaine (France)
Information provided by:
Association de Recherche Gerontologique

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Aging Frailty Behavioral: Mind-body exercises Behavioral: Adapted Tai-chi Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : May 2006
Actual Study Completion Date : February 2008

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. MOS SF-12

Secondary Outcome Measures :
  1. Timed Up and Go test

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: February 26, 2008    Key Record Dates
Last Update Posted: May 19, 2009
Last Verified: May 2009

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