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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Frail Elderly, Physical Activity

Intervention / Treatment
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* Other: MEFAP
* Other: control usual practice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MEFAP<br>MEFAP (multicomponent physical activity program) for 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: MEFAP<br>* 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).<br>Other: control usual practice<br>* Individuals allocated to this arm, will be look after as usual in their health Centers.<br>|
| Active Comparator: Control: usual practice<br>No intervention. Individuals allocated to this arm, will be look after as usual in their health Centers. | Other: control usual practice<br>* Individuals allocated to this arm, will be look after as usual in their health Centers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline frail elderly level at one year | 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) | one year after the intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline frail elderly level at at the end of the intervention (12 weeks) | 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 (12 weeks) | 
| Change from baseline frail elderly level at at the at 6 month | 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) | 6 month after the intervention | 
| Adherence to intervention | degree of adherence to the program (number of sessions with assistance) | at the end of the intervention (12 weeks) | 
| Euroqol utilities | Euroqol descriptive system (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) | at the end of the intervention (12 weeks), | 
| Visual Analog Scale | A Visual Analog Scale with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status) | at the end of the intervention (12 weeks), | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, physical activity, exercise, frailty