Heart FailureNCT07128784
Aerobic Training and Cardiopulmonary Responses In Heart Failure
An observational study of Heart Failure and Cardiopulmonary Exercise Test, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the short-term effects of aerobic exercise in heart failure patients who were given exercise prescription with cardiopulmonary exercise stres test acocording to aerobic capacity . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Heart Failure, Cardiopulmonary Exercise Test, Aerobic Capacity
- What is being tested?
- Aerobic exercise
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 20 Jun 2025
- Phase
- Observational
- 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
Study population: 18-75 age of years , male and female , diagnosed with heart failure with reduced EF
Who may be able to join
- Age 18-75,
- Diagnosed with compensated HF,
- BMI 18-30 kg/m²,
- LVEF < 0.4,
- NYHA 2-3,
- Clinical symptoms have been stable for at least 2 weeks, and the dose of angiotensin-converting enzyme inhibitor/angiotensin receptor antagonist/angiotensin receptor inhibitor, beta-blocker, aldosterone inhibitor, and other drugs has been stable for at least 2 weeks.
Who cannot join
- History of a heart implant device within the last 6 weeks or a heart implant device or heart transplant plan within the next 12 months,
- Acute coronary syndrome within the last 6 weeks, severe valvular heart disease, congenital heart disease, severe hypertrophic obstructive cardiomyopathy, acute myocarditis/pericarditis, intracardiac thrombosis, primary pulmonary hypertension,
- Uncontrolled hypertension (systolic blood pressure >200 mmHg and/or diastolic blood pressure >110 mmHg),
- Severe arrhythmias such as ventricular tachycardia, frequent multisource premature ventricular beats, high atrioventricular block, and significant QT interval prolongation during exercise testing,
- Progressive dyspnea or
- Loss of exercise endurance at rest within the last 3-5 days under low-intensity exercise load (<2 MET) who have suffered myocardial ischemia,
- Patients with cognitive impairment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Aerobic Exercise Training on Cardiopulmonary Exercise Capacity in Patients With Heart Failure
The goal of this observational study is to learn about the short-term effects of aerobic exercise in heart failure patients who were given exercise prescription with cardiopulmonary exercise stres test acocording to aerobic capacity . The main question it aims to answer is:
Does aerobic exercise increase aerobic capacity and quality of life Participants already taking aerobic capacity as part of their regular medical care for Heart failure will asses with cardiopulmonary exercise test and clinical questionaries about quality of life and depression-anxiety level before and after aerobic exercise treatment .
Read the detailed description
The goal of this observational study is to learn about the short-term effects of aerobic exercise in heart failure patients who were given exercise prescription with cardiopulmonary exercise stres test acocording to aerobic capacity . The main question it aims to answer is:
Does aerobic exercise increase aerobic capacity and quality of life Participants already taking aerobic capacity as part of their regular medical care for Heart failure will asses with cardiopulmonary exercise test and clinical questionaries about quality of life and depression-anxiety level before and after aerobic exercise treatment .
- Being tested
- Aerobic exercise
- Keywords
- cardiopulmonary exercise test, aerobic capacity, aerobic exercise, heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
continuous, moderate intencity aerobic exercise, 3 days a week, 30 minutes per day, 150/min per week for a total of 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| aerobic exercise | Not described Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiopulmonary exercise test results
Cardiovascular responses: VO2 max value (ml/kg/dk)
Measured: 6 weeks
cardiopulmonary exercise test results
Cardiovascular responses: heart rate (bpm, beats/min)
Measured: 6 weeks
cardiopulmonary exercise test results
gas exchange response: VE/VCO2: EQCO2: Ventilatory equivalent for carbon dioxide minute ventilation while the produced CO₂ is removed,
Measured: 6 weeks
cardiovascular exercise test result: Gas exchange parameters:
PETCO₂ (partial end-tidal carbon dioxide), kilopascal
Measured: 6 weeks
Secondary outcomes (2)
Short Form (36) Health Scale
Short Form (36) Health Scale
Description:
The SF-36 is a widely used, patient-reported survey of health status designed to assess overall health-related quality of life. It evaluates physical and mental health across multiple dimensions and is commonly used in clinical research and health outcomes studies.
Domains Assessed (8 Subscales): Physical Functioning , Role Limitations due to Physical Health,Pain, General Health Perceptions Vitality, Social Functioning, Role Limitations due to Emotional Problems, Mental Health
These can also be summarized into two main component scores:
Physical Component Summary (PCS) Mental Component Summary (MCS)
Scoring Range:
Each subscale is scored from 0 to 100. 0 represents the worst possible health status; 100 represents the best possible health status.
Interpretation of Scores:
Higher scores indicate better health outcomes and higher quality of life, lower scores reflect poorer perceived healt
Measured: 6 weeks
Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a self-assessment tool developed to detect states of anxiety and depression in patients in non-psychiatric hospital clinics. It is widely used in both clinical practice and research settings to screen for emotional distress, especially in individuals with physical illnesses.
Structure:
The scale consists of 14 items, divided into two subscales:
HADS-A (Anxiety) - 7 items HADS-D (Depression) - 7 items Each item assesses symptoms experienced over the past week.
Scoring Range:
Each item is scored from 0 to 3. Subscale scores range from 0 to 21 for both anxiety and depression.
Interpretation of Scores (per subscale):
0-7: Normal 8-10: Borderline abnormal (mild) 11-21: Abnormal (clinically significant)
Direction of Scores:
Higher scores indicate greater severity of anxiety or depression symptoms. Lower scores suggest fewer or no symptoms.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Apr 2025
- Primary completion15 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07128784
- Sponsor's protocol ID
- TABED 2-25-1203
- Status last verified
- Aug 2025
- First submitted
- 12 Jun 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lelonek M. Heart failure with preserved ejection fraction after the PARAGON-HF trial results: current knowledge and future directions. Kardiol Pol. 2020 Dec 23;78(12):1199-1205. doi: 10.33963/KP.15639. Epub 2020 Oct 6.
PubMed 33021355Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet. 2018 Feb 10;391(10120):572-580. doi: 10.1016/S0140-6736(17)32520-5. Epub 2017 Nov 21.
PubMed 29174292
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Aerobic Exercise Training on Cardiopulmonary Exercise Capacity in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT07128784
- Acronym / sponsor ID
- TABED 2-25-1203
- Keywords
- cardiopulmonary exercise test, aerobic capacity, aerobic exercise, heart failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 19 Aug 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.
The goal of this observational study is to learn about the short-term effects of aerobic exercise in heart failure patients who were given exercise prescription with cardiopulmonary exercise stres test acocording to aerobic capacity . The main question it aims to answer is:
Does aerobic exercise increase aerobic capacity and quality of life Participants already taking aerobic capacity as part of their regular medical care for Heart failure will asses with cardiopulmonary exercise test and clinical questionaries about quality of life and depression-anxiety level before and after aerobic exercise treatment .
Detailed description
The goal of this observational study is to learn about the short-term effects of aerobic exercise in heart failure patients who were given exercise prescription with cardiopulmonary exercise stres test acocording to aerobic capacity . The main question it aims to answer is:
Does aerobic exercise increase aerobic capacity and quality of life Participants already taking aerobic capacity as part of their regular medical care for Heart failure will asses with cardiopulmonary exercise test and clinical questionaries about quality of life and depression-anxiety level before and after aerobic exercise treatment .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aerobic exercise | – | Other: Aerobic exercise |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18-75 age of years , male and female , diagnosed with heart failure with reduced EF
Key inclusion criteria (6 listed)
- Age 18-75,
- Diagnosed with compensated HF,
- BMI 18-30 kg/m²,
- LVEF < 0.4,
- NYHA 2-3,
Key exclusion criteria (7 listed)
- History of a heart implant device within the last 6 weeks or a heart implant device or heart transplant plan within the next 12 months,
- Acute coronary syndrome within the last 6 weeks, severe valvular heart disease, congenital heart disease, severe hypertrophic obstructive cardiomyopathy, acute myocarditis/pericarditis, intracardiac thrombosis, primary pulmonary hypertension,
- Uncontrolled hypertension (systolic blood pressure >200 mmHg and/or diastolic blood pressure >110 mmHg),
- Severe arrhythmias such as ventricular tachycardia, frequent multisource premature ventricular beats, high atrioventricular block, and significant QT interval prolongation during exercise testing,
- Progressive dyspnea or
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 |
|---|---|---|
| Aerobic exercisecontinuous, moderate intencity aerobic exercise, 3 days a week, 30 minutes per day, 150/min per week for a total of 6 weeks | Other | aerobic exercise |
Primary outcome
cardiopulmonary exercise test results
Time frame: 6 weeks
Cardiovascular responses: VO2 max value (ml/kg/dk)
cardiopulmonary exercise test results
Time frame: 6 weeks
Cardiovascular responses: heart rate (bpm, beats/min)
cardiopulmonary exercise test results
Time frame: 6 weeks
gas exchange response: VE/VCO2: EQCO2: Ventilatory equivalent for carbon dioxide minute ventilation while the produced CO₂ is removed,
cardiovascular exercise test result: Gas exchange parameters:
Time frame: 6 weeks
PETCO₂ (partial end-tidal carbon dioxide), kilopascal
2 secondary outcomes
Short Form (36) Health Scale
Time frame: 6 weeks
Hospital Anxiety and Depression Scale
Time frame: 6 weeks
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 19 Aug 2025.
- Background: PubMed 33021355Lelonek M. Heart failure with preserved ejection fraction after the PARAGON-HF trial results: current knowledge and future directions. Kardiol Pol. 2020 Dec 23;78(12):1199-1205. doi: 10.33963/KP.15639. Epub 2020 Oct 6.
- Background: PubMed 29174292Conrad N, Judge A, Tran J, Mohseni H, Hedgecott D, Crespillo AP, Allison M, Hemingway H, Cleland JG, McMurray JJV, Rahimi K. Temporal trends and patterns in heart failure incidence: a population-based study of 4 million individuals. Lancet. 2018 Feb 10;391(10120):572-580. doi: 10.1016/S0140-6736(17)32520-5. Epub 2017 Nov 21.
- 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?
An observational study of Heart Failure and Cardiopulmonary Exercise Test, 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 6 inclusion and 7 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 19 Aug 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?
cardiopulmonary exercise test results (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 NCT07128784, which also lists 2 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 19 Aug 2025.