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SARS-CoV-2 Pandemic
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEFAP | Experimental | 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). |
|
| Control: usual practice | Active Comparator | No intervention. Individuals allocated to this arm, will be look after as usual in their health Centers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEFAP | Other | 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). |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maria Victoria Castell | Madrid | 28035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30691405 | Derived | Castell MV, Gutierrez-Misis A, Sanchez-Martinez M, Prieto MA, Moreno B, Nunez S, Triano R, de Antonio MP, Mateo C, Cano MD, Garrido A, Julian R, Polentinos E, Rodriguez-Barrientos R, Otero Puime A; MEFAP Group. Effectiveness of an intervention in multicomponent exercise in primary care to improve frailty parameters in patients over 70 years of age (MEFAP-project), a randomised clinical trial: rationale and study design. BMC Geriatr. 2019 Jan 28;19(1):25. doi: 10.1186/s12877-018-1024-8. |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient.
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|
| control usual practice | Other | Individuals allocated to this arm, will be look after as usual in their health Centers. |
|
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), |