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NCT00623532 Clinical Trial

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

Aging Clinical Trial

Official title:
A Randomized Interventional Study of a Cognition-Action Physical Activity and Adapted Tai-Chi in Frail Institutionalized Elderly

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00623532
Other study ID # AGR-2006-01-Etude MARGE
Secondary ID
Status Completed
Phase N/A
First received February 15, 2008
Last updated May 18, 2009
Start date May 2006
Est. completion date February 2008

Study information
Verified date May 2009
Source Association de Recherche Gerontologique
Contact n/a
Is FDA regulated No
Health authority France: Direction Générale de la SantéFrance: French Data Protection AuthorityFrance: Institutional Ethical Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date February 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Mind-body exercises

• Adapted Tai-chi

Locations
Country Name City State
France Hopital Xavier Arnozan, CHU de Bordeaux Bordeaux Gironde

Sponsors (2)
Lead Sponsor Collaborator
Association de Recherche Gerontologique Conseil Régional d'Aquitaine (France)

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary MOS SF-12 No
Secondary Timed Up and Go test
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