Multidomain Intervention to preveNt Disability in ElDers
n 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. This project will yield the necessary preliminary data to design a definitive full-scale Phase 3 randomized clinical trial.
The study methods (as well as its objectives) have not been modified from the original version approved by the ANR.
We will conduct a single-blind randomized controlled trial testing the effect of a multidomain intervention (focused on physical, cognitive, and nutritional domains) on the incidence of mobility disability in a sample of community-dwelling non-disabled frail older persons.
MINDED is a pilot study specifically aimed at testing the feasibility of the intervention, determining the requirements, validating the instruments, and providing the statistical foundations necessary for the design of the future Phase 3 trial on the topic.
During the first months of the present three-year project, multiple key-tasks have been accomplished. In particular, we have:
1) Formalized the needed collaborations with local partners in order to develop the infrastructures where the study will be conducted. In particular:
a) The Rehabilitation Center “La Roseraie” has been identified as primary site where participants will be assessed and followed-up during the MINDED project.
b) All the majors of towns in the Labastide-Murat area as well as the local healthcare authorities (e.g., Agence Regionale de Santé) and professionals (e.g., general practitioners, nurses, physical therapists, pharmacists,…) have been informed of the project we are going to develop. This is a crucial component of the study because will concur at maximizing the inclusions and promote the adherence to the study interventions. Moreover, with their support, we have been able to develop the necessary infrastructures (previously absent) to develop a research site in the rural area object of the study.
c) All the required study personnel has been identified. We will formally recruit some of them as soon as all the administrative procedures will be completed and participants could be enrolled.
2) A preliminary survey in the area of Labastide-Murat has been conducted in order to describe the overall population of older persons potentially of interest for the study. Results of the survey have already been published in French as well as in English.
3) All the study documentation (protocol/manual of procedures, data collection forms, ads for recruitment) have been prepared and ready to be used.
En apportant des re´ponses concernant l’impact d’un programme de pre´vention multidomaine , les re´sultats de l’e´tude de phase 3 pourront avoir des retombe´es importantes en termes de sante´ publique, et pourraient promouvoir la pratique d’une me´decine pre´ventive base´e sur les preuves.
The first paper describing the results of the preliminary survey conducted in the study area to describe the prevalence of frailty and disability in the study population has been published in French and in English.
Cesari M, Demougeot L, Boccalon H, Vellas B. Prévalence de la fragilité et de la perte de mobilité dans une zone rural en France. Cah Année Gérontol in press
Cesari M, Demougeot L, Boccalon H, Vellas B. Prevalence of frailty and mobility limitation in a rural setting in France. J Frailty Aging in press
Please, note that the MINDED project has been also described in its design, organization, and preliminary results (namely the preliminary survey) at several national and international scientific meetings.
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 hetegoreneous 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. This 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. Dr. Cesari, a recognized expert in the field of frailty, was contacted during the prepaparation of an IHU project related to aging research and prevention of disability in Toulouse. In this context, he has joined the Unit to develop major progams aimed at the prevention of disability in older persons.
Monsieur Matteo Cesari (INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE - Délégation régionale Midi-Pyrénées Limousin) – email@example.com
The author of this summary is the project coordinator, who is responsible for the content of this summary. The ANR declines any responsibility as for its contents.
INSERM INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE - Délégation régionale Midi-Pyrénées Limousin
Help of the ANR 450,000 euros
Beginning and duration of the scientific project: January 2012 - 36 Months