Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
208

Summary

Conditions
  • Frail Elderly
  • Physical Activity
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient.Masking: Single (Outcomes Assessor)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 70 years and 100 years
Gender
Both males and females

Description

Objective: To evaluate the effect of a multicomponent physical activity program, compared with the usual medical practice, to reverse prefrailty by Fried in people over 70 years, one year after the end of the intervention. Location: primary care setting (Madrid Region). Population: non-dependent and...

Objective: To evaluate the effect of a multicomponent physical activity program, compared with the usual medical practice, to reverse prefrailty by Fried in people over 70 years, one year after the end of the intervention. Location: primary care setting (Madrid Region). Population: non-dependent and pre-frailty patients ? 70 years old, who attend the health centers included in the study. Design: Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient. Intervention: multicomponent physical activity program (MEFAP) with 12 weekly sessions of an hour and a half which includes 1) briefing 2) exercises for improving aerobic resistance, muscle strength, proprioception -balance and flexibility and 3) delivery of exercise chart to do at home (two times per week). Main measures: Main variable: pre-frailty according to Fried phenotype. Secondary variables: sociodemographic, clinical and function variables; adherence, user satisfaction, quality of life. Analysis: It will be carried out an analysis by intention to treat comparing the retrogression from pre-frailty (1 or 2 Fried criteria) to robust (0 Fried criteria) at the end of the intervention, 6 months after the intervention and one year after the intervention. Cumulative incidence, Relative Risk and Number Needed to Treat with a 95% Confidence Interval. A Generalized Estimating Equation logit model will be adjusted to analyze the associated factors.

Tracking Information

NCT #
NCT03568084
Collaborators
Not Provided
Investigators
Not Provided