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

Gerencia de Atención Primaria, Madrid

Status: Terminated

Conditions: Physical Activity; Frail Elderly

Treatments: Other: control usual practice; Other: MEFAP

Study type: Interventional

Funder types: Other

Identifiers

NCT03568084

PI17/01889

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 70 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

MEFAP

Experimental group

Description:

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).

Treatment:

Other: control usual practice

Other: MEFAP

Control: usual practice

Active Comparator group

Description:

No intervention. Individuals allocated to this arm, will be look after as usual in their health Centers.

Treatment:

Other: control usual practice