Clinical trial NCT02082171: Multidomain Intervention to Prevent Disability in Elders
Official title: Multidomain Intervention to Prevent Disability in Elders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Frailty
Physical Disability
Mobility Disability
Keywords: older adults
physical disability
multidomain intervention
prevention
pilot study
frailty
mobility
comprehensive geriatric assessment
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
Collaborators: name: National Research Agency, France
First posted: 2014-03-10
Enrollment: 210
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: 400-meter walk test
timeFrame: 12 months
Secondary outcomes:
measure: Participants' adherence/retention to the intervention protocol and control groups
timeFrame: 12 months
measure: Intercurrent illnesses rates
timeFrame: 12 months
measure: Serious fall injuries
timeFrame: 12 months
measure: Hospitalizations and institutionalization rates
timeFrame: 12 months
measure: Mortality
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 12 months
measure: Body composition modifications
timeFrame: 12 months
measure: Modification of Pain
timeFrame: 12 months
measure: Fatigue
timeFrame: 12 months
Other outcomes:
Locations:
city: Montfaucon
country: France
facility: Centre de Rééducation Fonctionnelle "La Roseraie"
Study officials:
affiliation: Inserm UMR1027, Université de Toulouse III Paul Sabatier, Toulouse, France
name: Matteo Cesari, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: