Effects of an Exercise Program in Women Over 60 yr. With HFpEF and Sarcopenia on Functional Capacity and Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise Program, Usual Care.
- Who it may be relevant to
- Registry conditions: Heart Failure With Preserved Ejection Fraction (HFpEF), Sarcopenia, Women. Basic parameters: from 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- 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.
Primary outcome measures
- Peak oxygen consumption [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.]
Secondary outcome measures (2)
- Sarcopenia [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 [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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Hospital Clínico Universitario de Valencia — Valencia
Identifiers
NCT: NCT06655532 · TRAIN-SARC