NCT06655532

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

Effects of a Concurrent Training-based Exercise Program in Women Over 60 Years With Heart Failure With Preserved Ejection Fraction and Sarcopenia on Functional Capacity, Quality of Life and Cognitive Function

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Exercise Program	Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training twice weekly.
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.

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-10-30
• Completion: 2026-01-30
• First posted: 2024-10-23
• Last updated: 2024-10-26

Locations

1 site across 1 country: Spain