An interventional study of Exercise Program and Usual Care in Heart Failure With Preserved Ejection Fraction (HFpEF), Sarcopenia and Women, sponsored by Fundación para la Investigación del Hospital Clínico de Valencia. Not yet recruiting at 1 site in Spain. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Fundación para la Investigación del Hospital Clínico de Valencia · Not applicable, Interventional, and Treatment
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.
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).
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →Fundación para la Investigación del Hospital Clínico de Valencia is the lead sponsor of 70 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Usual Care
Patients allocated to this arm will receive the usual care plus supervised aerobic and moderate to high-intensity strength training.
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.
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.
Peak oxygen consumption
Maximal functional capacity will be evaluated using incremental and symptom-limited cardiopulmonary exercise testing on a bicycle ergometer, beginning with a workload of 10 W and increasing gradually in a ramp protocol at 10-W increments every 1 minute. We define maximal functional capacity as when the patient stops pedalling because of symptoms and the respiratory exchange ratio (RER) was 1. During exercise, patients will be monitored with 12-lead electrocardiogram and blood pressure measurements every 2 minutes. Gas exchange data and cardiopulmonary variables were averages of values taken every 10 seconds. Peak oxygen consumption (PeakVO2) was defined as the highest value of VO2 during the last 20 seconds of exercise.
Time frame: Primary outcome: Peak oxygen consumption will be evaluated at first visit and after 12 weeks. We will evaluate peak oxygen consumption change from baseline.
Sarcopenia
SARC-F (strength, assistance in walking, rise from a chair, climb stairs, and falls) it is a self-administered questionnaire that has five components: strength, assistance with walking, getting up from a chair, climbing stairs, and falls. It has a 3-level scoring system based on the level of difficulty, ranging from 0 (none) to 2 (very much), for each component.
Time frame: Sarcopenia: SARC Questionnaire will be evaluated at first visit, after 12 weeks and after 16 weeks. We will evaluate the Sarc-F Questionnaire change from baseline.
Kansas City Cardiomyopathy Questionnaire Scales
The Kansas City Cardiomyopathy Questionnaire includes 23 items that map to 7 domains: symptom frequency, symptom burden, symptom stability, physical limitations, social limitations, quality of life, and self-efficacy (the patient understanding of how to manage their heart failure). All Kansas City cardiomyopathy Questionnaire domains are scaled from 0 to 100, where scores represent health status as follows: 0 to 24, very poor to poor; 25 to 49, poor to fair; 50 to 74, fair to good; and 75 to 100, good to excellent. A change of 5 points is considered to be a small but clinically important change, whereas changes of 10 and 20 points are considered moderate-to-large and large-to-very-large clinical changes.
Time frame: The Kansas City Cardiomyopathy Questionnaire will be evaluated at first visit, after 12 weeks and after 16 weeks. We will evaluate the Kansas City Cardiomyopathy Questionnaire change from baseline.
Plan to share: No
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This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Fundación para la Investigación del Hospital Clínico de Valencia