Aerobic Versus Combined Exercise and Diastolic Dysfunction

Not Applicable

Completed

• Conditions: Diastolic Dysfunction; Heart Failure
• Interventions: Other: aerobic exercise; Other: combined exercise

• Registration Number: NCT04916184
• Lead Sponsor: Evangelismos Hospital

Brief Summary

Thirty-two stable patients with chronic heart failure participated in an exercise rehabilitation program. They randomly assigned to aerobic exercise (AER) or combined aerobic and strength training (COM). Before and after the program, they underwent a symptom-limited maximal cardiopulmonary exercise testing and serial echocardiography evaluation examining the indices of diastolic dysfunction (DD).

Detailed Description

Thirty-two stable patients with chronic heart failure (age: 56 ± 10 years, EF: 32 ± 8%, 88 % men) participated in an exercise rehabilitation program. They randomly assigned to aerobic exercise (AER) or combined aerobic and strength training (COM), based on age and peak oxygen uptake, as stratified randomization criteria. Before and after the program, they underwent a symptom-limited maximal cardiopulmonary exercise testing (CPET) and serial echocardiography assessment to evaluate peak oxygen uptake (VO2peak), peak workload (Wpeak), DD grade, right ventricular systolic pressure (RVSP) and EF.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2021-02-01
• Study First Submitted: 2021-05-19
• Status Verified: 2021-06
• Study First Submitted QC: 2021-06-03
• Last Update Submitted: 2021-06-03
• Study First Posted: 2021-06-07
• Last Update Posted: 2021-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• chronic heart failure

Exclusion Criteria

• atrial fibrillation COPD

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined exercise	combined exercise	effects on diastolic dysfunction in patients with stable chronic heart failure
aerobic exercise	aerobic exercise	effects on diastolic dysfunction in patients with stable chronic heart failure
aerobic exercise	combined exercise	effects on diastolic dysfunction in patients with stable chronic heart failure
Combined exercise	aerobic exercise	effects on diastolic dysfunction in patients with stable chronic heart failure

Primary Outcome Measures

Name	Time	Method
Evaluation of the impact of a cardiac rehabilitation program on the diastolic dysfunction in patients with chronic heart failure	three months	Thirty-two stable patients with chronic heart failure (age: 56 ± 10 years, EF: 32 ± 8%, 88 % men) participated in an exercise rehabilitation program. They randomly assigned to aerobic exercise (AER) or combined aerobic and strength training (COM), based on age and peak oxygen uptake, as stratified randomization criteria. Before and after the program, they underwent a serial echocardiography assessment to evaluate the diastolic dysfunction (DD) grade of the left ventricular.
Evaluation of the impact of a cardiac rehabilitation program on the ejection fraction of the left ventricular in patients with chronic heart failure	three months	Thirty-two stable patients with chronic heart failure (age: 56 ± 10 years, EF: 32 ± 8%, 88 % men) participated in an exercise rehabilitation program. They randomly assigned to aerobic exercise (AER) or combined aerobic and strength training (COM), based on age and peak oxygen uptake, as stratified randomization criteria. Before and after the program, they underwent a serial echocardiography assessment to evaluate the ejection fraction of the left ventricular.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the impact of a cardiac rehabilitation program on the indices of aerobic exercise capacity of the left ventricular in patients with chronic heart failure	three months	Thirty-two stable patients with CHF (age: 56 ± 10 years, EF: 32 ± 8%, 88 % men) participated in an exercise rehabilitation program. They randomly assigned to aerobic exercise (AER) or combined aerobic and strength training (COM), based on age and peak oxygen uptake, as stratified randomization criteria. Before and after the program, they underwent a cardiopulmonary exercise test to evaluate VO2peak and Wpeak

Trial Locations

Locations (1)

Serafim Nanas; 🇬🇷 Athens, Attica, Greece