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Multidomain Intervention to Prevent Disability in Elders (MINDED)

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ClinicalTrials.gov Identifier: NCT02082171
Recruitment Status : Unknown
Verified February 2015 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Recruiting
First Posted : March 10, 2014
Last Update Posted : February 6, 2015
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Physical Frailty Physical Disability Mobility Disability Other: Multidomain intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Multidomain Intervention to Prevent Disability in Elders
Study Start Date : October 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
No Intervention: Control group
Experimental: Intervention group
Comprehensive geriatric assessment followed by multi-domain preventive intervention
Other: Multidomain intervention
Multidomain preventive intervention designed by a multidisciplinary team on the basis of results of a comprehensive geriatric assessment




Primary Outcome Measures :
  1. 400-meter walk test [ Time Frame: 12 months ]
    Incident inability to complete the 400-meter walk test in the two randomization groups


Secondary Outcome Measures :
  1. Participants' adherence/retention to the intervention protocol and control groups [ Time Frame: 12 months ]
    Participants' adherence/retention to the intervention protocol

  2. Intercurrent illnesses rates [ Time Frame: 12 months ]
    Intercurrent illnesses rates in the two randomization groups

  3. Serious fall injuries [ Time Frame: 12 months ]
    Incident fall injuries occurred in the two randomization groups

  4. Hospitalizations and institutionalization rates [ Time Frame: 12 months ]
    Incidence of acute care hospitalizations and nursing home admissions in the two randomization groups

  5. Mortality [ Time Frame: 12 months ]
    Overall mortality rate in the two randomization groups

  6. Health-related quality of life [ Time Frame: 12 months ]
    Modifications of health-related quality of life in the two randomization groups

  7. Body composition modifications [ Time Frame: 12 months ]
    Body composition modifications (assessed using bioimpedance analysis) in the two randomization groups

  8. Pain [ Time Frame: 12 months ]
    Modification of pain symptoms in the two randomization groups

  9. Fatigue [ Time Frame: 12 months ]
    Modification of the fatigue symptom in the two randomization groups



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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);
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02082171


Contacts
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Contact: Matteo Cesari, MD, PhD +33 (0)5 61145628 macesari@gmail.com
Contact: Laurent Demougeot, PhD demougeot.l@chu-toulouse.fr

Locations
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France
Centre de Rééducation Fonctionnelle "La Roseraie" Recruiting
Montfaucon, France, 46240
Principal Investigator: Matteo Cesari, MD, PhD         
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
National Research Agency, France
Investigators
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Principal Investigator: Matteo Cesari, MD, PhD Inserm UMR1027, Université de Toulouse III Paul Sabatier, Toulouse, France

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT02082171     History of Changes
Other Study ID Numbers: C12-55
2013-A00380-45 ( Registry Identifier: IDRCB )
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: February 2015

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:
older adults
physical disability
multidomain intervention
prevention
pilot study
frailty
mobility
comprehensive geriatric assessment

Additional relevant MeSH terms:
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Frailty
Pathologic Processes