Effects of an Exercise Program in Women Over 60 yr. With HFpEF and Sarcopenia on Functional Capacity and Quality of Life

NCT ID: NCT06655532

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2026-01-30

Brief Summary

This prospective study will randomize (1:1) women with heart failure with preserved ejection fraction (HFpEF) and sarcopenia to receive standard management alone or a combined 12-week supervised exercise program (combining aerobic and strength exercise) carried out in a single centre.

After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing (CPET) at 12 weeks. Women over 60 with HFpEF, functional class NYHA class II-III, and sarcopenia criteria will be enrolled. A sample size estimation [alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +1.9 mL/kg/min (SD±2)] of 40 patients (20 per arm) would be necessary to test our hypothesis.

Detailed Description

Heart failure with preserved ejection fraction (HFpEF) is a highly prevalent clinical entity that predominantly affects women, whose incidence has increased in the last decade and has a complex and multifactorial pathophysiology. Sarcopenia, a prevalent concurrent condition, appears to be associated with reduced muscle strength and reduced maximal functional capacity.

Supervised training programs in patients with heart failure with reduced ejection fraction and sarcopenia have improved functional capacity. However, the researchers do not have evidence about the effects of a supervised training program on patients with HFpEF and sarcopenia, mainly when affecting women older than 60. This work aims to evaluate the effect of a 12-week supervised exercise program in patients with HFpEF and sarcopenia on maximal functional capacity evaluated by peak oxygen consumption (peakVO2).

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF); Sarcopenia; Women

Study Design

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

Study Groups

Usual care

Patients allocated to this arm will receive the standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training.

Group Type: SHAM_COMPARATOR

Usual Care

Intervention Type: BEHAVIORAL

Patients allocated to this arm will receive standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training. They will also receive a weekly phone call and an in-person monthly visit to monitor exercise training performance.

Supervised aerobic plus moderate to high-intensity strenght training

Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training.

Group Type: ACTIVE_COMPARATOR

Exercise Program

Intervention Type: BEHAVIORAL

Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training twice weekly.

Interventions

Exercise Program

Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training twice weekly.

Intervention Type: BEHAVIORAL

Usual Care

Patients allocated to this arm will receive standard medical treatment plus explicit recommendations for 12-week home-based moderate-intensity aerobic and strength training. They will also receive a weekly phone call and an in-person monthly visit to monitor exercise training performance.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with heart failure with preserved ejection fraction according to 2021 ESC guidelines for Heart Failure, with N-terminal pro-B-type natriuretic peptide (NT-proBNP) >125 pg/mL, inthe last month.
• Stable symptomatic heart failure patients (New York Heart Association functional class II-III) during the last month.
• Age ≥ 60 years old.
• The participant is willing to give informed consent to participate in the study.
• SARC-F score ≥4 points.

Exclusion Criteria

• Inability to perform a valid baseline cardiopulmonary exercise test.
• Cardiac pacemaker.
• Significant primary moderate-to-severe valve disease.
• Effort angina or signs of ischemia during CPET.
• Primary cardiomyopathies.
• Cardiac transplantation.
• Any other comorbidity with a life expectancy of less than one year.

• Minimum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura López Bueno, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto de Investigacion Sanitaria INCLIVA

Locations

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Countries

Spain

Central Contacts

Laura López Bueno

Role: CONTACT

Laura.Lopez@uv.es

650682744

Other Identifiers

TRAIN-SARC

Identifier Type: -

Identifier Source: org_study_id