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

Fundación para la Investigación del Hospital Clínico de Valencia

Status: Not yet enrolling

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

Treatments: Behavioral: Usual Care; Behavioral: Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06655532

TRAIN-SARC

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Usual care

Sham Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care

Supervised aerobic plus moderate to high-intensity strenght training

Active Comparator group

Description:

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

Treatment:

Behavioral: Exercise Program