Clinical trial NCT03568084: Effectiveness of an Intervention in Multicomponent Exercise in Patients Over 70 Years in Primary Care
Official title: Effectiveness of an Intervention in Multicomponent Exercise (MEFAP) in Patients Over 70 Years in Primary Care: Reversibility of Prefrailty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Frail Elderly
Physical Activity
Keywords: elderly
physical activity
exercise
frailty
Lead sponsor: Gerencia de Atención Primaria, Madrid
Sponsor class: OTHER_GOV
First posted: 2018-06-26
Enrollment: 206
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized parallel group multicenter clinical trial. Randomization unit and Unit of analysis: Patient.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change from baseline frail elderly level at one year
timeFrame: one year after the intervention.
Secondary outcomes:
measure: Change from baseline frail elderly level at at the end of the intervention (12 weeks)
timeFrame: at the end of the intervention (12 weeks)
measure: Change from baseline frail elderly level at at the at 6 month
timeFrame: 6 month after the intervention
measure: Adherence to intervention
timeFrame: at the end of the intervention (12 weeks)
measure: Euroqol utilities
timeFrame: at the end of the intervention (12 weeks),
measure: Visual Analog Scale
timeFrame: at the end of the intervention (12 weeks),
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Maria Victoria Castell
Study officials:
References:
citation: 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.