Effectiveness of an Intervention in Multicomponent Exercise (MEFAP) in Patients Over 70 Years in Primary Care: Reversibility of Prefrailty
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Frail Elderly
- Sponsor
- Gerencia de Atención Primaria, Madrid
- Enrollment
- 206
- Locations
- 1
- Primary Endpoint
- Change from baseline frail elderly level at one year
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individuals aged \>70 years with a Barthel test ≥90 and pre-frailty (1-2 Fried phenotype frailty criteria).
- •For Health Care Centers: Centers who deliver patient to Physiotherapy Units who participate in this Project. Centers where at least two General Practitioners accept to participate in the Project.
Exclusion Criteria
- •Moderate to severe dependency (impairment) for daily living activities (Barthel test \<90)
- •Enable to achieve Health Care Center for any reason.
- •Moderate to severe cognitive impairment (MEC 35 Lobo≤21)
- •Severe illness that contraindicates to practice exercise by medical criteria: recent hearth attack (6 months), not controlled arrhythmia, severe hearth valvular disease, not controlled arterial hypertension (systolic blood pressure\>180/diastolic blood pressure\>100), severe heart failure, severe respiratory failure, diabetes mellitus with frequent acute hypoglycemia, any other circumstance that makes the individual unable to do exercise under medical criteria.
Outcomes
Primary Outcomes
Change from baseline frail elderly level at one year
Time Frame: one year after the intervention.
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)
Secondary Outcomes
- Change from baseline frail elderly level at at the at 6 month(6 month after the intervention)
- Visual Analog Scale(at the end of the intervention (12 weeks),)
- Change from baseline frail elderly level at at the end of the intervention (12 weeks)(at the end of the intervention (12 weeks))
- Adherence to intervention(at the end of the intervention (12 weeks))
- Euroqol utilities(at the end of the intervention (12 weeks),)