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NOT YET RECRUITING
NCT06640140
NA

Effects of a Supervised Training Program on Functional Capacity in Patients With HF and Cardiorenal Syndrome

Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

View on ClinicalTrials.gov

Summary

This is a prospective study, blinded for the evaluator, randomized (1:1) to receive standard management alone or combined with a training program (aerobic combined with strength exercises) that will be carried out in a single center. After randomization, patients will be clinically evaluated. The primary endpoint (peakVO2) will be assessed by cardiopulmonary exercise testing combined with echocardiography (echo-CPET) at 12 weeks. Ambulatory patients with heart failure and cardiorenal syndrome and functional class NYHA II-III will be enrolled. A sample size estimation \[alfa: 0.05, power: 80%, a 20% loss rate, and at least a delta change of mean peakVO2: +2,4 mL/kg/min (SD±2)\] of 26 patients (13 per arm) would be necessary to test our hypothesis.

Official title: Effects of a Supervised Training Program on Functional Capacity in Patients With Heart Failure and Cardiorenal Syndrome

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2024-10-08

Completion Date

2025-12

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

BEHAVIORAL

Supervised aerobic plus strength training

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

Locations (1)

Instituto de investigación sanitaria INCLIVA

Valencia, Spain