Multidomain Intervention to Prevent Disability in Elders (MINDED)

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 Overview

• Status: Completed
• Conditions: Physical Disability; Physical Frailty; Mobility Disability
• Intervention / Treatment: Other: Multidomain intervention

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montfaucon, France, 46240
    • Centre de Rééducation Fonctionnelle "La Roseraie"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
400-meter walk test	Incident inability to complete the 400-meter walk test in the two randomization groups	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants' adherence/retention to the intervention protocol and control groups	Participants' adherence/retention to the intervention protocol	12 months
Intercurrent illnesses rates	Intercurrent illnesses rates in the two randomization groups	12 months
Serious fall injuries	Incident fall injuries occurred in the two randomization groups	12 months
Hospitalizations and institutionalization rates	Incidence of acute care hospitalizations and nursing home admissions in the two randomization groups	12 months
Mortality	Overall mortality rate in the two randomization groups	12 months
Health-related quality of life	Modifications of health-related quality of life in the two randomization groups	12 months
Body composition modifications	Body composition modifications (assessed using bioimpedance analysis) in the two randomization groups	12 months
Modification of Pain	Modification of pain symptoms in the two randomization groups	12 months
Fatigue	Modification of the fatigue symptom in the two randomization groups	12 months

Collaborators and Investigators

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Collaborators: National Research Agency, France
• Investigators: Principal Investigator: Matteo Cesari, MD, PhD, Inserm UMR1027, Université de Toulouse III Paul Sabatier, Toulouse, France

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2013
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 27, 2016

Study Registration Dates

• First Submitted: March 6, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (Estimated): March 10, 2014

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 27, 2025
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: older adults; frailty; prevention; physical disability; multidomain intervention; pilot study; mobility; comprehensive geriatric assessment
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty
• Other Study ID Numbers: C12-55; 2013-A00380-45 (Registry Identifier: IDRCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No