NCT07245459

Brief Summary

In this study, it is aimed to investigate the effects of a cardiac rehabilitation program consisting of two different aerobic exercise modalities on aerobic capacity, symptoms, quality of life, and sarcopenia in patients with heart failure who present with one or more symptoms such as dyspnea, difficulty walking, muscle weakness, or limitations in activities of daily living and who are in need of cardiac rehabilitation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable heart-failure

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

August 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

November 13, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

heart failurecardiac rehabilitationsarcopeniaMyokines

Outcome Measures

Primary Outcomes (1)

  • VO2 max

    The maximal oxygen uptake (VO2max) in Cardiopulmonary exercise test (CPET)

    Day 1 and 6th week

Secondary Outcomes (2)

  • Myostatin

    Day 1 and 6th week

  • BDNF

    Day 1 and 6th week

Study Arms (2)

HIIT (high intensity interval training)

EXPERIMENTAL

For the HIIT group, the first week consists of three sessions including a 5-minute warm-up at 30% of VO₂max, 20 minutes of exercise at 60% of VO₂max, and a 5-minute cool-down at 30% of VO₂max. Starting from the second week, interval training will be implemented as follows: 5 sessions of 20 minutes with intervals alternating between 65-80% of VO₂max for 60 seconds and 50% of VO₂max for 120 seconds; 5 sessions of 20 minutes alternating 65-80% of VO₂max for 120 seconds and 50% of VO₂max for 120 seconds; and 5 sessions of 20 minutes alternating 65-80% of VO₂max for 240 seconds and 50% of VO₂max for 180 seconds.

Other: HIIT (high intensity interval training)

MCT (moderate intensity continuous training)

EXPERIMENTAL

For the MCT group, the program will be included a 5-minute warm-up at 30% of VO₂max, followed by 20 minutes of continuous exercise at 60% of VO₂max, and a 5-minute cool-down at 30% of VO₂max.

Other: MCT (moderate intensity continuous training)

Interventions

For the HIIT group, the first week consists of three sessions including a 5-minute warm-up at 30% of VO₂max, 20 minutes of exercise at 60% of VO₂max, and a 5-minute cool-down at 30% of VO₂max. Starting from the second week, interval training will be implemented as follows: 5 sessions of 20 minutes with intervals alternating between 65-80% of VO₂max for 60 seconds and 50% of VO₂max for 120 seconds; 5 sessions of 20 minutes alternating 65-80% of VO₂max for 120 seconds and 50% of VO₂max for 120 seconds; and 5 sessions of 20 minutes alternating 65-80% of VO₂max for 240 seconds and 50% of VO₂max for 180 seconds

HIIT (high intensity interval training)

For the MCT group, the program will be included a 5-minute warm-up at 30% of VO₂max, followed by 20 minutes of continuous exercise at 60% of VO₂max, and a 5-minute cool-down at 30% of VO₂max.

MCT (moderate intensity continuous training)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-75 years heart failure (HF) NYHA class II-III left ventricular ejection fraction (LVEF) \<0.40, BMI between 18-30 kg/m² standard medications at stable doses for at least two weeks prior to enrollment

You may not qualify if:

  • a history of cardiac implant device placement within the previous 6 weeks a planned cardiac device implantation heart transplantation within the next 12 months acute coronary syndrome within the prior 6 weeks severe valvular or congenital heart disease severe hypertrophic obstructive cardiomyopathy acute myocarditis or pericarditis intracardiac thrombus primary pulmonary hypertension peripartum cardiomyopathy uncontrolled hypertension (systolic blood pressure \>200 mmHg and/or diastolic blood pressure \>110 mmHg) severe arrhythmias.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent City Hospital

Ankara, Çankaya, 06800, Turkey (Türkiye)

Location

Related Publications (3)

  • Li Q, Zhang L, Zhang Z, Wang Y, Zuo C, Bo S. A Shorter-Bout of HIIT Is More Effective to Promote Serum BDNF and VEGF-A Levels and Improve Cognitive Function in Healthy Young Men. Front Physiol. 2022 Jun 29;13:898603. doi: 10.3389/fphys.2022.898603. eCollection 2022.

    PMID: 35846013BACKGROUND
  • Donelli da Silveira A, Beust de Lima J, da Silva Piardi D, Dos Santos Macedo D, Zanini M, Nery R, Laukkanen JA, Stein R. High-intensity interval training is effective and superior to moderate continuous training in patients with heart failure with preserved ejection fraction: A randomized clinical trial. Eur J Prev Cardiol. 2020 Nov;27(16):1733-1743. doi: 10.1177/2047487319901206. Epub 2020 Jan 21.

    PMID: 31964186BACKGROUND
  • Springer J, Springer JI, Anker SD. Muscle wasting and sarcopenia in heart failure and beyond: update 2017. ESC Heart Fail. 2017 Nov;4(4):492-498. doi: 10.1002/ehf2.12237.

    PMID: 29154428BACKGROUND

MeSH Terms

Conditions

Heart FailureSarcopenia

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients will be blinded to group allocation, and the exercise group will be determined through randomization, after which the appropriate program will be administered accordingly.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ankara Bilkent City Hospital

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 24, 2025

Study Start

August 1, 2022

Primary Completion

December 30, 2024

Study Completion

February 1, 2025

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations