AgingNCT00623532
Intervention Study of Mind-Body Physical Activity in Frail Institutionalized Elderly
A study testing Mind-body exercises and Adapted Tai-chi in people with Aging and Frailty, run by Association de Recherche Gerontologique at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- What is being tested?
- Mind-body exercises and Adapted Tai-chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Terminally ill and bedridden patients
- Unable or unwilling to sign the consent
- Have participated in a study in the past 3 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Interventional Study of a Cognition-Action Physical Activity and Adapted Tai-Chi in Frail Institutionalized Elderly
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.
- Being tested
- Mind-body exercises, Adapted Tai-chi
- Keywords
- Tertiary prevention of disability
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body exercisesBehavioural
Adapted Tai-chiBehavioural
| Study group | Role | What they receive |
|---|---|---|
| CA | Experimental | 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". Receives: Behavioral: Mind-body exercises |
| AT | Active comparator | Adapted Tai Chi is based on Tai Chi like movements Receives: Behavioral: Adapted Tai-chi |
| C | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOS SF-12
Secondary outcomes (1)
Timed Up and Go test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startMay 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Gerontologique
- Sponsor type
- University, hospital or other
- Collaborators
- Conseil Régional d'Aquitaine (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623532
- Sponsor's protocol ID
- AGR-2006-01-Etude MARGE
- Status last verified
- May 2009
- First submitted
- 15 Feb 2008
- Last updated
- 19 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20101011
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Interventional Study of a Cognition-Action Physical Activity and Adapted Tai-Chi in Frail Institutionalized Elderly
- ClinicalTrials.gov ID
- NCT00623532
- Acronym / sponsor ID
- AGR-2006-01-Etude MARGE
- Keywords
- Tertiary prevention of disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Association de Recherche GerontologiqueUniversity, hospital or other
- Collaborators
- Conseil Régional d'Aquitaine (France)
- Study start
- May 2006
- Study completion
- Feb 2008 (actual)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CA | Experimental | Behavioral: Mind-body exercisesCognition 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". |
| AT | Active comparator | Behavioral: Adapted Tai-chiAdapted Tai Chi is based on Tai Chi like movements |
| C | No intervention | –Control |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Terminally ill and bedridden patients
- Unable or unwilling to sign the consent
- Have participated in a study in the past 3 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-body exercises | Behavioural | CA |
| Adapted Tai-chi | Behavioural | AT |
Primary outcome
MOS SF-12
1 secondary outcome
Timed Up and Go test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2009.
- Derived from this study: PubMed 20101011Dechamps 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body exercises and Adapted Tai-chi in people with Aging and Frailty, run by Association de Recherche Gerontologique at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOS SF-12. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00623532, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2009; AzTrials last refreshed its copy on 6 Nov 2026.