NCT04916184

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 7, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

5 years

First QC Date

May 19, 2021

Last Update Submit

June 3, 2021

Conditions

Keywords

diastolic dysfunctionexercise training

Outcome Measures

Primary Outcomes (2)

  • 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 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

    three months

Study Arms (2)

aerobic exercise

ACTIVE COMPARATOR

effects on diastolic dysfunction in patients with stable chronic heart failure

Other: aerobic exerciseOther: combined exercise

Combined exercise

ACTIVE COMPARATOR

effects on diastolic dysfunction in patients with stable chronic heart failure

Other: aerobic exerciseOther: combined exercise

Interventions

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

Combined exerciseaerobic exercise

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

Combined exerciseaerobic exercise

Eligibility Criteria

Age36 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic heart failure

You may not qualify if:

  • atrial fibrillation COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Serafim Nanas

Athens, Attica, 10676, Greece

Location

Related 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.

    PMID: 20562711BACKGROUND
  • 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.

    PMID: 27037982BACKGROUND
  • 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.

MeSH Terms

Conditions

Heart Failure

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2021

First Posted

June 7, 2021

Study Start

January 1, 2016

Primary Completion

December 31, 2020

Study Completion

February 1, 2021

Last Updated

June 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations