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

Primary Purpose

Aging, Frailty

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mind-body exercises
Adapted Tai-chi
Sponsored by
Association de Recherche Gerontologique
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Tertiary prevention of disability

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Xavier Arnozan, CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

CA

AT

C

Arm Description

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".

Adapted Tai Chi is based on Tai Chi like movements

Control

Outcomes

Primary Outcome Measures

MOS SF-12

Secondary Outcome Measures

Timed Up and Go test

Full Information

First Posted
February 15, 2008
Last Updated
May 18, 2009
Sponsor
Association de Recherche Gerontologique
Collaborators
Conseil Régional d'Aquitaine (France)
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1. Study Identification

Unique Protocol Identification Number
NCT00623532
Brief Title
Intervention Study of Mind-Body Physical Activity in Frail Institutionalized Elderly
Official Title
A Randomized Interventional Study of a Cognition-Action Physical Activity and Adapted Tai-Chi in Frail Institutionalized Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Association de Recherche Gerontologique
Collaborators
Conseil Régional d'Aquitaine (France)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Frailty
Keywords
Tertiary prevention of disability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CA
Arm Type
Experimental
Arm Description
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".
Arm Title
AT
Arm Type
Active Comparator
Arm Description
Adapted Tai Chi is based on Tai Chi like movements
Arm Title
C
Arm Type
No Intervention
Arm Description
Control
Intervention Type
Behavioral
Intervention Name(s)
Mind-body exercises
Intervention Type
Behavioral
Intervention Name(s)
Adapted Tai-chi
Primary Outcome Measure Information:
Title
MOS SF-12
Secondary Outcome Measure Information:
Title
Timed Up and Go test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hopital Xavier Arnozan, CHU de Bordeaux
City
Bordeaux
State/Province
Gironde
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
20101011
Citation
Dechamps A, Diolez P, Thiaudiere E, Tulon A, Onifade C, Vuong T, Helmer C, Bourdel-Marchasson I. Effects of exercise programs to prevent decline in health-related quality of life in highly deconditioned institutionalized elderly persons: a randomized controlled trial. Arch Intern Med. 2010 Jan 25;170(2):162-9. doi: 10.1001/archinternmed.2009.489.
Results Reference
derived

Learn more about this trial

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

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