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

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

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.

Study Overview

• Status: Terminated
• Conditions: Physical Activity; Frail Elderly
• Intervention / Treatment: Other: MEFAP; Other: control usual practice

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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28035
    • Maria Victoria Castell

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MEFAP; 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; 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).; Other: control usual practice; Individuals allocated to this arm, will be look after as usual in their health Centers.
Active Comparator: Control: usual practice; No intervention. Individuals allocated to this arm, will be look after as usual in their health Centers.	Other: control usual practice; Individuals allocated to this arm, will be look after as usual in their health Centers.

What is the study measuring?

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),

Collaborators and Investigators

• Sponsor: Gerencia de Atención Primaria, Madrid

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): March 10, 2020

Study Registration Dates

• First Submitted: May 24, 2018
• First Submitted That Met QC Criteria: June 13, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: physical activity; exercise; frailty; elderly
• Other Study ID Numbers: PI17/01889

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No