At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Preserved Ejection Function and Chronotropic Incompetence
In Brief
A clinical study evaluating Supervised aerobic training, Supervised aerobic plus low to moderate-intensity strength training, and 1 other intervention for Heart Failure With Preserved Ejection Fraction and Chronotropic Incompetence. Completed, enrolled 80 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Supervised moderate to high-intensity interval aerobic training
Supervised moderate to high-intensity interval aerobic training plus low to moderate-intensity strength training
Supervised moderate to high-intensity interval aerobic training plus moderate to high-intensity strength training