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

Physical Activity Clinical Trial

— MEFAP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03568084
• Other study ID #: PI17/01889
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: March 10, 2020

Study information

• Verified date: April 2022
• Source: Gerencia de Atención Primaria, Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 206
• Est. completion date: March 10, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Frail Elderly
• Physical Activity

Intervention

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

Locations

Country	Name	City	State
Spain	Maria Victoria Castell	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Gerencia de Atención Primaria, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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
Secondary	Adherence to intervention	degree of adherence to the program (number of sessions with assistance)	at the end of the intervention (12 weeks)
Secondary	Euroqol utilities	Euroqol descriptive system (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression)	at the end of the intervention (12 weeks),
Secondary	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),