Aerobic Versus Combined Exercise and Diastolic Dysfunction

NCT ID: NCT04916184

Last Updated: 2021-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-02-01

Brief Summary

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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

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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.

Conditions

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Diastolic Dysfunction Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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aerobic exercise

effects on diastolic dysfunction in patients with stable chronic heart failure

Group Type ACTIVE_COMPARATOR

aerobic exercise

Intervention Type OTHER

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

combined exercise

Intervention Type OTHER

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

Combined exercise

effects on diastolic dysfunction in patients with stable chronic heart failure

Group Type ACTIVE_COMPARATOR

aerobic exercise

Intervention Type OTHER

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

combined exercise

Intervention Type OTHER

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

Interventions

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aerobic exercise

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

Intervention Type OTHER

combined exercise

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* chronic heart failure

Exclusion Criteria

* atrial fibrillation COPD
Minimum Eligible Age

36 Years

Maximum Eligible Age

71 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Evangelismos Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ioannis Chaveles

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Serafim Nanas

Athens, Attica, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type BACKGROUND
PMID: 20562711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27037982 (View on PubMed)

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.

Reference Type RESULT
PMID: 33392386 (View on PubMed)

Other Identifiers

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43/28.03.2016

Identifier Type: -

Identifier Source: org_study_id

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