Physical FrailtyMINDEDNCT02082171
Multidomain Intervention to Prevent Disability in Elders
A study testing Multidomain intervention in people with Physical Frailty and Physical Disability, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Prevention of physical disability represents a major priority for the public health system. Physical disability is the final result of a complex cascade of negative events occurring at different levels (i.e., environmental, social, biological, and clinical). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Physical Frailty, Physical Disability, Mobility Disability
- What is being tested?
- Multidomain intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2013to 27 Jan 2016
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 60 years and older;
- Willingness to be randomized to either treatment group;
- Pre-frailty or frailty status according to the phenotype described by Fried and colleagues
Who cannot join
- Failure to provide informed consent;
- Inability to complete a 400-meter walk test (primary outcome of the study);
- Living in nursing home;
- Living outside of the area of interest, or planning to move out of the area in next 3 years, or planning to leave the area for more than 3 months during the next year;
- Relevant cognitive impairment (defined as a known diagnosis of dementia);
- Severe progressive, degenerative neurologic disease (e.g., multiple sclerosis);
Show all 11Show fewer
- Severe rheumatologic or orthopaedic diseases (e.g., awaiting joint replacement);
- Terminal illness with life expectancy less than 12 months;
- Severe pulmonary disease (e.g., oxygen therapy or chronic use of steroids);
- Severe cardiac disease (e.g., New York Heart Association Class III or IV heart failure, clinically significant aortic stenosis, history of cardiac arrest, uncontrolled angina);
- Other significant comorbid conditions that would impair the ability to participate in the multidomain intervention (e.g., renal failure on hemodialysis, severe psychiatric disorder, excessive alcohol use). To be noted: persons with depression will not be excluded.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Rééducation Fonctionnelle "La Roseraie"
Montfaucon, 46240
About this study
Prevention of physical disability represents a major priority for the public health system. Physical disability is the final result of a complex cascade of negative events occurring at different levels (i.e., environmental, social, biological, and clinical). The heterogeneity of the underlying mechanisms responsible for the onset of physical disability may require the adoption of preventive interventions affecting multiple domains. Although several studies suggest that single or different combinations of preventive interventions (in particular, physical activity, cognitive training, and healthy diet) might provide beneficial effects in preventing functional loss (and its related features, such as pain or reduced quality of life), very limited evidence coming from clinical trials is currently available on the topic. Intervention trials are usually designed to test the effect of a specific monodimensional intervention on a very selected population, so to reduce the risk of biased results. This approach, although legitimate and methodologically correct, may 1) be insufficient to target the multiple and heterogeneous physiopathological mechanisms underlying the onset of physical disability, and 2) cause a population selection bias leading to difficulties in implementing the study results to the overall older population (thus, determining the "evidence-based medicine" issue in the elderly). To our knowledge, there are no available data from clinical trials evaluating the effects of a multidomain intervention based on lifestyle modifications (e.g., physical activity, cognitive training, nutritional modification) for preventing mobility disability (a very early phase of the disabling process) in community-dwelling older persons. In the present project (Multidomain Intervention to preveNt Disability in ElDers, MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain person-tailored preventive intervention (based on physical activity, cognitive training, and nutritional modifications) on frailty status, physical performance, cognitive function, nutritional status, health-related quality of life, and use of health care services. In addition, we will perform cost-effectiveness analyses of the proposed intervention. The project will yield the necessary preliminary data to design a definitive full-scale Phase 3 randomized clinical trial. By providing a conclusive answer about the effectiveness of a multidimensional preventive program in the primary prevention of major health-related outcomes, the results of the full-scale trial will have relevant clinical and public health implications, and will promote the practicing of a truly evidence-based geriatric medicine.
- Conditions
- Physical Frailty, Physical Disability, Mobility Disability
- Being tested
- Multidomain intervention
- Keywords
- older adults, physical disability, multidomain intervention, prevention, pilot study, frailty, mobility, comprehensive geriatric assessment
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidomain interventionOther
Multidomain preventive intervention designed by a multidisciplinary team on the basis of results of a comprehensive geriatric assessment
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Intervention group | Experimental | Comprehensive geriatric assessment followed by multi-domain preventive intervention Receives: Other: Multidomain intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
400-meter walk test
Incident inability to complete the 400-meter walk test in the two randomization groups
Measured: 12 months
Secondary outcomes (9)
Participants' adherence/retention to the intervention protocol and control groups
Participants' adherence/retention to the intervention protocol
Measured: 12 months
Intercurrent illnesses rates
Intercurrent illnesses rates in the two randomization groups
Measured: 12 months
Serious fall injuries
Incident fall injuries occurred in the two randomization groups
Measured: 12 months
Hospitalizations and institutionalization rates
Incidence of acute care hospitalizations and nursing home admissions in the two randomization groups
Measured: 12 months
Mortality
Overall mortality rate in the two randomization groups
Measured: 12 months
Health-related quality of life
Modifications of health-related quality of life in the two randomization groups
Measured: 12 months
Body composition modifications
Body composition modifications (assessed using bioimpedance analysis) in the two randomization groups
Measured: 12 months
Modification of Pain
Modification of pain symptoms in the two randomization groups
Measured: 12 months
Fatigue
Modification of the fatigue symptom in the two randomization groups
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study start16 Oct 2013
- Primary completionJan 2016
- Study completion27 Jan 2016
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 Physical FrailtyStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Matteo Cesari, MD, PhD, Principal investigator, Inserm UMR1027, Université de Toulouse III Paul Sabatier, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082171
- Sponsor's protocol ID
- C12-55
- Other IDs
- 2013-A00380-45
- Acronym
- MINDED
- Status last verified
- Aug 2021
- First submitted
- 6 Mar 2014
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cesari M, Demougeot L, Boccalon H, Guyonnet S, Vellas B, Andrieu S. The Multidomain Intervention to preveNt disability in ElDers (MINDED) project: rationale and study design of a pilot study. Contemp Clin Trials. 2014 May;38(1):145-54. doi: 10.1016/j.cct.2014.04.006. Epub 2014 Apr 24.
PubMed 24768939
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multidomain Intervention to Prevent Disability in Elders
- ClinicalTrials.gov ID
- NCT02082171
- Acronym / sponsor ID
- MINDED / C12-55
- Conditions
- Physical Frailty, Physical Disability, Mobility Disability
- Keywords
- older adults, physical disability, multidomain intervention, prevention, pilot study, frailty, mobility, comprehensive geriatric assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- National Research Agency, France
- Study start
- 16 Oct 2013 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 27 Jan 2016 (actual)
- First posted
- 10 Mar 2014 (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.
Prevention of physical disability represents a major priority for the public health system. Physical disability is the final result of a complex cascade of negative events occurring at different levels (i.e., environmental, social, biological, and clinical). The heterogeneity of the underlying mechanisms responsible for the onset of physical disability may require the adoption of preventive interventions affecting multiple domains. Although several studies suggest that single or different combinations of preventive interventions (in particular, physical activity, cognitive training, and healthy diet) might provide beneficial effects in preventing functional loss (and its related features, such as pain or reduced quality of life), very limited evidence coming from clinical trials is currently available on the topic. Intervention trials are usually designed to test the effect of a specific monodimensional intervention on a very selected population, so to reduce the risk of biased results. This approach, although legitimate and methodologically correct, may 1) be insufficient to target the multiple and heterogeneous physiopathological mechanisms underlying the onset of physical disability, and 2) cause a population selection bias leading to difficulties in implementing the study results to the overall older population (thus, determining the "evidence-based medicine" issue in the elderly). To our knowledge, there are no available data from clinical trials evaluating the effects of a multidomain intervention based on lifestyle modifications (e.g., physical activity, cognitive training, nutritional modification) for preventing mobility disability (a very early phase of the disabling process) in community-dwelling older persons. In the present project (Multidomain Intervention to preveNt Disability in ElDers, MINDED), we propose to conduct a pilot study aimed at estimating the effects of a multidomain person-tailored preventive intervention (based on physical activity, cognitive training, and nutritional modifications) on frailty status, physical performance, cognitive function, nutritional status, health-related quality of life, and use of health care services. In addition, we will perform cost-effectiveness analyses of the proposed intervention. The project will yield the necessary preliminary data to design a definitive full-scale Phase 3 randomized clinical trial. By providing a conclusive answer about the effectiveness of a multidimensional preventive program in the primary prevention of major health-related outcomes, the results of the full-scale trial will have relevant clinical and public health implications, and will promote the practicing of a truly evidence-based geriatric medicine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Intervention group | Experimental | Other: Multidomain interventionComprehensive geriatric assessment followed by multi-domain preventive intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 60 years and older;
- Willingness to be randomized to either treatment group;
- Pre-frailty or frailty status according to the phenotype described by Fried and colleagues
Key exclusion criteria (11 listed)
- Failure to provide informed consent;
- Inability to complete a 400-meter walk test (primary outcome of the study);
- Living in nursing home;
- Living outside of the area of interest, or planning to move out of the area in next 3 years, or planning to leave the area for more than 3 months during the next year;
- Relevant cognitive impairment (defined as a known diagnosis of dementia);
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 |
|---|---|---|
| Multidomain interventionMultidomain preventive intervention designed by a multidisciplinary team on the basis of results of a comprehensive geriatric assessment | Other | Intervention group |
Primary outcome
400-meter walk test
Time frame: 12 months
Incident inability to complete the 400-meter walk test in the two randomization groups
9 secondary outcomes
Participants' adherence/retention to the intervention protocol and control groups
Time frame: 12 months
Intercurrent illnesses rates
Time frame: 12 months
Serious fall injuries
Time frame: 12 months
Hospitalizations and institutionalization rates
Time frame: 12 months
Mortality
Time frame: 12 months
Health-related quality of life
Time frame: 12 months
Body composition modifications
Time frame: 12 months
Modification of Pain
Time frame: 12 months
Fatigue
Time frame: 12 months
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 4 Sep 2025.
- Background: PubMed 24768939Cesari M, Demougeot L, Boccalon H, Guyonnet S, Vellas B, Andrieu S. The Multidomain Intervention to preveNt disability in ElDers (MINDED) project: rationale and study design of a pilot study. Contemp Clin Trials. 2014 May;38(1):145-54. doi: 10.1016/j.cct.2014.04.006. Epub 2014 Apr 24.
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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.
Matteo Cesari, MD, PhD principal investigator
Inserm UMR1027, Université de Toulouse III Paul Sabatier, Toulouse, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidomain intervention in people with Physical Frailty and Physical Disability, run by Institut National de la Santé Et de la Recherche Médicale, France 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 3 inclusion and 11 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 4 Sep 2025. 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?
400-meter walk test (time frame: 12 months). 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 NCT02082171, 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 4 Sep 2025.