Multidomain Intervention to Prevent Disability in Elders

NCT02082171 | Completed DMC

• 2 other identifiers: C12-552013-A00380-45
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Frailty; Physical Disability; Mobility Disability

Keywords

older adults; physical disability; multidomain intervention; prevention; pilot study; frailty; mobility; comprehensive geriatric assessment

Outcome Measures

Primary Outcomes (1)

• 400-meter walk test

  Incident inability to complete the 400-meter walk test in the two randomization groups

  12 months

Secondary Outcomes (9)

• Participants' adherence/retention to the intervention protocol and control groups

  12 months

• Intercurrent illnesses rates

  12 months

• Serious fall injuries

  12 months

• Hospitalizations and institutionalization rates

  12 months

• Mortality

  12 months

Study Arms (2)

Control group

NO INTERVENTION

Intervention group

EXPERIMENTAL

Comprehensive geriatric assessment followed by multi-domain preventive intervention

Other: Multidomain intervention

Interventions

Multidomain intervention OTHER

Multidomain preventive intervention designed by a multidisciplinary team on the basis of results of a comprehensive geriatric assessment

Intervention group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead
• National Research Agency, France: collaborator

Study Sites (1)

Centre de Rééducation Fonctionnelle "La Roseraie"

Montfaucon, 46240, France

Location

Related Publications (1)

• 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.

  PMID: 24768939 BACKGROUND

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matteo Cesari, MD, PhD

  Inserm UMR1027, Université de Toulouse III Paul Sabatier, Toulouse, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2014
• First Posted: March 10, 2014
• Study Start: October 16, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 27, 2016
• Last Updated: September 4, 2025

Record last verified: 2021-08

Locations

FR (1)