Aerobic Versus Combined Exercise and Diastolic Dysfunction

Heart Failure Clinical Trial

Official title:

Effects of Exercise Training on Diastolic and Systolic Dysfunction in Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916184
• Other study ID #: 43/28.03.2016
• Status: Completed
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: February 1, 2021

Study information

• Verified date: June 2021
• Source: Evangelismos Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 36 Years to 71 Years

Eligibility

Inclusion Criteria:

• chronic heart failure

Exclusion Criteria:

• atrial fibrillation COPD

Related Conditions & MeSH terms

• Diastolic Dysfunction
• Heart Failure

Intervention

Other:
• aerobic exercise
exercise training rehabilitation (aerobic exercise with/without strength training)
• combined exercise
exercise training rehabilitation (aerobic exercise with/without strength training)

Locations

Country	Name	City	State
Greece	Serafim Nanas	Athens	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Evangelismos Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (3)

Bouchla A, Karatzanos E, Dimopoulos S, Tasoulis A, Agapitou V, Diakos N, Tseliou E, Terrovitis J, Nanas S. The addition of strength training to aerobic interval training: effects on muscle strength and body composition in CHF patients. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):47-51. doi: 10.1097/HCR.0b013e3181e174d7. Erratum in: J Cardiopulm Rehabil Prev. 2011 Nov;31(6):E1. — View Citation

Kourek C, Alshamari M, Mitsiou G, Psarra K, Delis D, Linardatou V, Pittaras T, Ntalianis A, Papadopoulos C, Panagopoulou N, Vasileiadis I, Nanas S, Karatzanos E. The acute and long-term effects of a cardiac rehabilitation program on endothelial progenitor — View Citation

Nagueh SF, Smiseth OA, Appleton CP, Byrd BF 3rd, Dokainish H, Edvardsen T, Flachskampf FA, Gillebert TC, Klein AL, Lancellotti P, Marino P, Oh JK, Popescu BA, Waggoner AD. Recommendations for the Evaluation of Left Ventricular Diastolic Function by Echocardiography: An Update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2016 Apr;29(4):277-314. doi: 10.1016/j.echo.2016.01.011. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the impact of a cardiac rehabilitation program on the diastolic dysfunction in patients with chronic heart failure	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.	three months
Primary	Evaluation of the impact of a cardiac rehabilitation program on the ejection fraction of the left ventricular in patients with chronic heart failure	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.	three months
Secondary	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	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	three months