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CompletedNCT04916184Updated Jun 7, 2021

Aerobic Versus Combined Exercise and Diastolic Dysfunction

An interventional study of aerobic exercise and combined exercise in Diastolic Dysfunction and Heart Failure, sponsored by Evangelismos Hospital. Completed at 1 site in Greece. Open to participants aged 36 Years to 71 Years. Per ClinicalTrials.gov, last updated 2021-06-07.

Sponsored by Evangelismos Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 4 months after the study started (first participant enrolled Jan 2016, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
36 Years to 71 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Diastolic Dysfunction
  • Heart Failure

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Keywords

  • diastolic dysfunction
  • exercise training
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 32 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Evangelismos Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
36 Years to 71 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • chronic heart failure

Exclusion criteria

Exclusion Criteria:

  • atrial fibrillation COPD
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
32 participants (actual)

Study arms

  • Active comparator
    aerobic exercise

    effects on diastolic dysfunction in patients with stable chronic heart failure

    Other: aerobic exercise · Other: combined exercise

  • Active comparator
    Combined exercise

    effects on diastolic dysfunction in patients with stable chronic heart failure

    Other: aerobic exercise · Other: combined exercise

Interventions

  • Otheraerobic exercise

    exercise training rehabilitation (aerobic exercise with/without strength training)

  • Othercombined exercise

    exercise training rehabilitation (aerobic exercise with/without strength training)

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: three months

  2. 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.

    Time frame: three months

Secondary outcomes

  1. 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

    Time frame: three months

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Study locations

1 site
  • Serafim Nanas
    Athens, Attica 10676, Greece
08

References and documents

Publications

  • 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. PubMed 20562711 ↗
  • 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. PubMed 27037982 ↗
  • 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. PubMed 33392386 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04916184
Lead sponsor
Evangelismos Hospital
Responsible party
Ioannis Chaveles (Principal Investigator, Evangelismos Hospital) — Principal investigator
First posted
Jun 7, 2021
Start date
Jan 1, 2016
Primary completion
Dec 31, 2020
Completion
Feb 1, 2021
Last update
Jun 7, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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