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Effects of a Supervised Training Program on Functional Capacity in Patients With HFpEF and Chronotropic Incompetence

NCT05649787 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-02-27

No results posted yet for this study

Summary

This is a prospective study, blinded for the evaluator, randomized (1:1:1:1) to receive standard management alone or combined with a program of training (aerobic alone or combined with strength exercises) that will be 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. Patients with heart failure with preserved ejection fraction, functional class NYHA II-III, and chronotropic incompetence criteria will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 15% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)\] of 80 patients (20 per arm) would be necessary to test our hypothesis.

Conditions

Interventions

BEHAVIORAL

Supervised aerobic training

Supervised moderate to high-intensity interval aerobic training

BEHAVIORAL

Supervised aerobic plus low to moderate-intensity strength training

Supervised moderate to high-intensity interval aerobic training plus low to moderate-intensity strength training

BEHAVIORAL

Supervised aerobic plus moderate to high-intensity strength training

Supervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training

Sponsors & Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Principal Investigators

  • Patricia Palau, MD, PhD · Instituto de Investigacion Sanitaria INCLIVA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2024-11-18
Completion
2024-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649787 on ClinicalTrials.gov