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

NCT ID: NCT03568084

Last Updated: 2022-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2020-03-10

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.

Conditions

Frail Elderly; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

MEFAP

Intervention Type: 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).

control usual practice

Intervention Type: OTHER

Individuals allocated to this arm, will be look after as usual in their health Centers.

Control: usual practice

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

Group Type: ACTIVE_COMPARATOR

control usual practice

Intervention Type: OTHER

Individuals allocated to this arm, will be look after as usual in their health Centers.

Interventions

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).

Intervention Type: OTHER

control usual practice

Individuals allocated to this arm, will be look after as usual in their health Centers.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gerencia de Atención Primaria, Madrid

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maria Victoria Castell

Madrid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 30691405 (View on PubMed)

Other Identifiers

PI17/01889

Identifier Type: -

Identifier Source: org_study_id