Aerobic Versus Combined Exercise and Diastolic Dysfunction

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

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure; Diastolic Dysfunction
• Intervention / Treatment: Other: aerobic exercise; Other: combined exercise

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Athens, Attica, Greece, 10676
      • Serafim Nanas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• chronic heart failure

Exclusion Criteria:

• atrial fibrillation COPD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: aerobic exercise; effects on diastolic dysfunction in patients with stable chronic heart failure	Other: aerobic exercise; exercise training rehabilitation (aerobic exercise with/without strength training); Other: combined exercise; exercise training rehabilitation (aerobic exercise with/without strength training)
Active Comparator: Combined exercise; effects on diastolic dysfunction in patients with stable chronic heart failure	Other: aerobic exercise; exercise training rehabilitation (aerobic exercise with/without strength training); Other: combined exercise; exercise training rehabilitation (aerobic exercise with/without strength training)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Evangelismos Hospital

Publications and helpful links

General Publications

• 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. No abstract available.
• 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.
• 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 cells in chronic heart failure patients: Comparing two different exercise training protocols. Int J Cardiol Heart Vasc. 2020 Dec 24;32:100702. doi: 10.1016/j.ijcha.2020.100702. eCollection 2021 Feb.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: May 19, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): June 7, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: diastolic dysfunction; exercise training
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 43/28.03.2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No