Multidomain Intervention to Prevent Disability in Elders

Physical Disability Clinical Trial

— MINDED  

Official title:

Multidomain Intervention to Prevent Disability in Elders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082171
• Other study ID #: C12-55
• Secondary ID: 2013-A00380-45
• Status: Completed
• Phase: N/A
• Start date: October 16, 2013
• Est. completion date: January 27, 2016

Study information

• Verified date: August 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: January 27, 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Mobility Disability
• Physical Disability
• Physical Frailty

Intervention

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

Locations

Country	Name	City	State
France	Centre de Rééducation Fonctionnelle "La Roseraie"	Montfaucon

Sponsors (2)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France	National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	400-meter walk test	Incident inability to complete the 400-meter walk test in the two randomization groups	12 months
Secondary	Participants' adherence/retention to the intervention protocol and control groups	Participants' adherence/retention to the intervention protocol	12 months
Secondary	Intercurrent illnesses rates	Intercurrent illnesses rates in the two randomization groups	12 months
Secondary	Serious fall injuries	Incident fall injuries occurred in the two randomization groups	12 months
Secondary	Hospitalizations and institutionalization rates	Incidence of acute care hospitalizations and nursing home admissions in the two randomization groups	12 months
Secondary	Mortality	Overall mortality rate in the two randomization groups	12 months
Secondary	Health-related quality of life	Modifications of health-related quality of life in the two randomization groups	12 months
Secondary	Body composition modifications	Body composition modifications (assessed using bioimpedance analysis) in the two randomization groups	12 months
Secondary	Modification of Pain	Modification of pain symptoms in the two randomization groups	12 months
Secondary	Fatigue	Modification of the fatigue symptom in the two randomization groups	12 months