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
About this trial
This is an interventional prevention trial for Aging focused on measuring Tertiary prevention of disability
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
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
NCT ID
NCT00623532
First Posted
February 15, 2008
Last Updated
May 18, 2009
Sponsor
Association de Recherche Gerontologique
Collaborators
Conseil Régional d'Aquitaine (France)
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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