Aerobic Versus Combined Exercise and Diastolic Dysfunction
Primary Purpose
Diastolic Dysfunction, Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
aerobic exercise
combined exercise
Sponsored by
About this trial
This is an interventional treatment trial for Diastolic Dysfunction focused on measuring diastolic dysfunction, exercise training
Eligibility Criteria
Inclusion Criteria:
- chronic heart failure
Exclusion Criteria:
- atrial fibrillation COPD
Sites / Locations
- Serafim Nanas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
aerobic exercise
Combined exercise
Arm Description
effects on diastolic dysfunction in patients with stable chronic heart failure
effects on diastolic dysfunction in patients with stable chronic heart failure
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04916184
Brief Title
Aerobic Versus Combined Exercise and Diastolic Dysfunction
Official Title
Effects of Exercise Training on Diastolic and Systolic Dysfunction in Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Evangelismos Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diastolic Dysfunction, Heart Failure
Keywords
diastolic dysfunction, exercise training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aerobic exercise
Arm Type
Active Comparator
Arm Description
effects on diastolic dysfunction in patients with stable chronic heart failure
Arm Title
Combined exercise
Arm Type
Active Comparator
Arm Description
effects on diastolic dysfunction in patients with stable chronic heart failure
Intervention Type
Other
Intervention Name(s)
aerobic exercise
Intervention Description
exercise training rehabilitation (aerobic exercise with/without strength training)
Intervention Type
Other
Intervention Name(s)
combined exercise
Intervention Description
exercise training rehabilitation (aerobic exercise with/without strength training)
Primary Outcome Measure Information:
Title
Evaluation of the impact of a cardiac rehabilitation program on the diastolic dysfunction in patients with chronic heart failure
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 serial echocardiography assessment to evaluate the diastolic dysfunction (DD) grade of the left ventricular.
Time Frame
three months
Title
Evaluation of the impact of a cardiac rehabilitation program on the ejection fraction of the left ventricular in patients with chronic heart failure
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 serial echocardiography assessment to evaluate the ejection fraction of the left ventricular.
Time Frame
three months
Secondary Outcome Measure Information:
Title
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
Description
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
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic heart failure
Exclusion Criteria:
atrial fibrillation COPD
Facility Information:
Facility Name
Serafim Nanas
City
Athens
State/Province
Attica
ZIP/Postal Code
10676
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20562711
Citation
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.
Results Reference
background
PubMed Identifier
27037982
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. No abstract available.
Results Reference
background
PubMed Identifier
33392386
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 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.
Results Reference
result
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Aerobic Versus Combined Exercise and Diastolic Dysfunction
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