NCT03568084

Effectiveness of an Intervention in Multicomponent Exercise in Patients Over 70 Years in Primary Care

Effectiveness of an Intervention in Multicomponent Exercise (MEFAP) in Patients Over 70 Years in Primary Care: Reversibility of Prefrailty

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Gerencia de Atención Primaria, Madrid · Other Government
• Sex: All
• Age: 70 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Frail Elderly
• Physical Activity

Interventions

Type	Name	Description
OTHER	MEFAP	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).
OTHER	control usual practice	Individuals allocated to this arm, will be look after as usual in their health Centers.

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-02-01
• Completion: 2020-03-10
• First posted: 2018-06-26
• Last updated: 2022-04-18

Locations

1 site across 1 country: Spain