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

NCT06655532 | Not Yet Recruiting

• 1 other identifier: TRAIN-SARC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Heart Failure with Preserved Ejection Fraction; Sarcopenia; Cardiovascular Diseases; Heart Diseases; Heart Failure; Women

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• Sarcopenia

  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 will be evaluated at first visit, after 12 weeks and after 16 weeks. We will evaluate the Kansas City Cardiomyopathy Questionnaire change from baseline.

Study Arms (2)

Usual care

SHAM COMPARATOR

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

Supervised aerobic plus moderate to high-intensity strenght training

ACTIVE COMPARATOR

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

Behavioral: Exercise Program

Interventions

Exercise Program BEHAVIORAL

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

Supervised aerobic plus moderate to high-intensity strenght training

Usual Care BEHAVIORAL

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.

Usual care

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Sarcopenia; Cardiovascular Diseases; Heart Diseases; Heart Failure

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Laura López Bueno, PhD

  Instituto de Investigacion Sanitaria INCLIVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura López Bueno

CONTACT

650682744; Laura.Lopez@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective study, blinded for the evaluator, 2 randomized groups (1:1) to receive standard management alone or combined with a program of training that will be carried out in a single centre.

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: November 4, 2024
• Primary Completion: October 30, 2025
• Study Completion: January 30, 2026
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)