Heart FailureNCT07245459
Cardiac Rehabilitation in Heart Failure and Sarcopenia
A study testing HIIT (high intensity interval training) and MCT (moderate intensity continuous training) in people with Heart Failure, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- HIIT (high intensity interval training) and MCT (moderate intensity continuous training)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
About this study
Official title: The Effect of a Cardiac Rehabilitation Program Including Moderate-Intensity Continuous Exercise Training and High-Intensity Interval Exercise Training on Sarcopenia and Myokines in Patients With Heart Failure
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.
Read the detailed description
Patients who were followed up in the Heart Failure Clinic, aged 18-75, had stable clinical symptoms, and were referred to Cardiopulmonary Rehabilitation Unit for the cardiac rehabilitation program and met the inclusion criteria will be included in our study.
Prior to initiating the program, participants will be prescribed an individualized exercise regimen determined to be both effective and safe, based on their exercise capacity assessed through the CPET-derived optimal exercise prescription. For the MCT group, the program includes 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.
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.
Both groups will be completed a total of 18 sessions over 6 weeks, with training occurring three times per week. Resistance training exercises will be incorporated into the programs in both groups after the second week. Load increments of 5 watts will be applied based on patient tolerance.
- Conditions
- Heart Failure
- Being tested
- HIIT (high intensity interval training), MCT (moderate intensity continuous training)
- Keywords
- heart failure, cardiac rehabilitation, sarcopenia, Myokines
- Medical subject headings
- Heart Failure, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT (high intensity interval training)Other
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
MCT (moderate intensity continuous training)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: MCT (moderate intensity continuous training) |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
The maximal oxygen uptake (VO2max) in Cardiopulmonary exercise test (CPET)
Measured: Day 1 and 6th week
Secondary outcomes (2)
Myostatin
Measured: Day 1 and 6th week
BDNF
Measured: Day 1 and 6th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Aug 2022
- Primary completion30 Dec 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Responsible party
- Principal investigator, Ebru Alemdaroğlu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245459
- Sponsor's protocol ID
- E2-24-7194
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35846013Donelli 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.
PubMed 31964186Springer 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.
PubMed 29154428Sonmez M, Alemdaroglu E, Ata AM, Kafes H, Erguder BI, Nojadeh JN, Ordu Gokkaya NK. The effect of a cardiac rehabilitation program including moderate-intensity continuous exercise training and high-intensity interval exercise training on sarcopenia and myokines in patients with heart failure. Acta Cardiol. 2026 Jun;81(4):548-558. doi: 10.1080/00015385.2026.2677223. Epub 2026 May 27.
PubMed 42200871
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Cardiac Rehabilitation Program Including Moderate-Intensity Continuous Exercise Training and High-Intensity Interval Exercise Training on Sarcopenia and Myokines in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07245459
- Acronym / sponsor ID
- E2-24-7194
- Conditions
- Heart Failure
- Keywords
- heart failure, cardiac rehabilitation, sarcopenia, Myokines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Collaborators
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who were followed up in the Heart Failure Clinic, aged 18-75, had stable clinical symptoms, and were referred to Cardiopulmonary Rehabilitation Unit for the cardiac rehabilitation program and met the inclusion criteria will be included in our study.
Prior to initiating the program, participants will be prescribed an individualized exercise regimen determined to be both effective and safe, based on their exercise capacity assessed through the CPET-derived optimal exercise prescription. For the MCT group, the program includes 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.
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.
Both groups will be completed a total of 18 sessions over 6 weeks, with training occurring three times per week. Resistance training exercises will be incorporated into the programs in both groups after the second week. Load increments of 5 watts will be applied based on patient tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIIT (high intensity interval training) | Experimental | Other: HIIT (high intensity interval training)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. |
| MCT (moderate intensity continuous training) | Experimental | Other: MCT (moderate intensity continuous 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- -
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT (high intensity interval training)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)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) |
Primary outcome
VO2 max
Time frame: Day 1 and 6th week
The maximal oxygen uptake (VO2max) in Cardiopulmonary exercise test (CPET)
2 secondary outcomes
Myostatin
Time frame: Day 1 and 6th week
BDNF
Time frame: Day 1 and 6th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 35846013Li 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.
- Background: PubMed 31964186Donelli 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.
- Background: PubMed 29154428Springer 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.
- Derived from this study: PubMed 42200871Sonmez M, Alemdaroglu E, Ata AM, Kafes H, Erguder BI, Nojadeh JN, Ordu Gokkaya NK. The effect of a cardiac rehabilitation program including moderate-intensity continuous exercise training and high-intensity interval exercise training on sarcopenia and myokines in patients with heart failure. Acta Cardiol. 2026 Jun;81(4):548-558. doi: 10.1080/00015385.2026.2677223. Epub 2026 May 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT (high intensity interval training) and MCT (moderate intensity continuous training) in people with Heart Failure, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max (time frame: Day 1 and 6th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07245459, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.