Effectiveness of an Intervention in Multicomponent Exercise in Patients Over 70 Years in Primary Care
Last updated on July 2021Recruitment
- 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