- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07245459
Cardiac Rehabilitation in Heart Failure and Sarcopenia
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey (Türkiye), 06800
- Ankara Bilkent City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
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Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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
|
|
Experimental: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VO2 max
Time Frame: Day 1 and 6th week
|
The maximal oxygen uptake (VO2max) in Cardiopulmonary exercise test (CPET)
|
Day 1 and 6th week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Myostatin
Time Frame: Day 1 and 6th week
|
Day 1 and 6th week
|
|
BDNF
Time Frame: Day 1 and 6th week
|
Day 1 and 6th week
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Cardiovascular Diseases
- Neuromuscular Manifestations
- Pathological Conditions, Anatomical
- Heart Diseases
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Heart Failure
- Sarcopenia
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Conditioning, Human
- Exercise
- High-Intensity Interval Training
Other Study ID Numbers
- E2-24-7194
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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