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Effects of an Exercise Program in Women Over 60 yr. With HFpEF and Sarcopenia on Functional Capacity and Quality of Life
Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
60 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2024-11-04
Completion Date
2026-01-30
Last Updated
2024-10-26
Healthy Volunteers
No
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.
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.
Locations (1)
Hospital Clínico Universitario de Valencia
Valencia, Spain