Heart FailureNCT07155421
Effects of Early Cardiopulmonary Rehabilitation in Patients With Acute Decompensated Heart Failure
A study testing Early Cardiopulmonary Rehabilitation and Routine in-hospital care in people with Heart Failure, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Acute decompensated heart failure (ADHF) is a severe condition characterized by rapid deterioration of cardiac function, leading to impaired oxygen delivery and multi-organ dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Early Cardiopulmonary Rehabilitation and Routine in-hospital care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2025to 1 Jun 2026
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized with a diagnosis of acute decompensated heart failure
- Being clinically stable
Who cannot join
- Having diagnosed pulmonary, neurological, renal, liver, gastrointestinal, orthopedic or oncological pathologies
- Having cardiomyopathy or congestive pericarditis
- Recent heart surgery in the past 6 months
- New or suspected thromboembolic event
- Presence of open wounds, ulcerations or major dermatological diseases in the lower extremities
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University- Cerrahpasa, Cardiology Institute
Istanbul
About this study
Acute decompensated heart failure (ADHF) is a severe condition characterized by rapid deterioration of cardiac function, leading to impaired oxygen delivery and multi-organ dysfunction. ADHF often results in reduced physical and respiratory capacity, greater dependence on oxygen support, difficulty performing daily activities, and prolonged hospital stays. In recent years, early exercise-based cardiopulmonary rehabilitation (CPR) has been introduced as part of heart failure management. Evidence suggests that early CPR improves overall health and cardiac function in heart failure patients. However, data regarding its effects in ADHF remain limited. While some studies indicate that early CPR enhances physical function, its impact on respiratory parameters and clinical outcomes is less well established.
Cardiopulmonary rehabilitation is a multidisciplinary program designed to promote physical, psychological, and social recovery in patients with cardiovascular and pulmonary diseases. It includes exercise training, education, psychosocial support, and behavioral strategies. Early CPR specifically aims to improve cardiovascular and respiratory functions in heart failure patients. Initiating CPR in the early phase of ADHF may accelerate recovery, strengthen cardiopulmonary function, shorten hospitalization, and improve quality of life.
This study aims to evaluate the effects of early CPR on functional capacity, hemodynamic parameters, and respiratory parameters in patients with ADHF.
- Conditions
- Heart Failure
- Being tested
- Early Cardiopulmonary Rehabilitation, Routine in-hospital care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Cardiopulmonary RehabilitationOther
An individualized CPR program including positioning, deep breathing exercises (diaphragmatic and segmental breathing exercises), pursed-lip breathing exercises, breathing exercises using incentive spirometry, and progressive mobilization exercises (in-bed range of motion exercises, sitting, standing, and walking exercises)
Routine in-hospital careOther
Routine in-hospital care for acute decompansated heart failure
| Study group | Role | What they receive |
|---|---|---|
| Early cardiopulmonary rehabilitation group | Experimental | Exercise-based cardiopulmonary rehabilitation will be applied to this group during the hospital stay every day for 3 times a day. Receives: Other: Early Cardiopulmonary Rehabilitation; Other: Routine in-hospital care |
| Control Group | Other | Routine in-hospital care will be applied to this group. Receives: Other: Routine in-hospital care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional capacity
It will be evaluated using 6-min walk test according to the guideline of American Thoracic Society
Measured: At baseline and at hospital discharge, up to 14 days after admission
Physical performance
It will evaluated using Short Physical Performance Battery.
Measured: At baseline and at hospital discharge, up to 14 days after admission
Secondary outcomes (5)
Maximum inspiratory and expiratory capacity
It will be evaluated using incentive spirometer.
Measured: At baseline and at hospital discharge, up to 14 days after admission
Hemodynamic responses to exercise
The change in heart rate before and after exercise will be recorded
Measured: At baseline and at hospital discharge, up to 14 days after admission
Hemodynamic responses to exercise
The change in blood pressure before and after exercise will be recorded
Measured: At baseline and at hospital discharge, up to 14 days after admission
Hemodynamic responses to exercise
The change in oxygen saturation before and after exercise will be recorded
Measured: At baseline and at hospital discharge, up to 14 days after admission
Subjective symptom responses to exercise
Subjective symptom responses to exercise will be evaluated by determining changes in the Modified Borg Dyspnea and Fatigue scales before and after exercise.
Measured: At baseline and at hospital discharge, up to 14 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start10 Nov 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Saglik Bilimleri Universitesi, Yeditepe University
- Responsible party
- Principal investigator, Melih Zeren, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155421
- Sponsor's protocol ID
- bakircaymzeren09
- Status last verified
- Jun 2026
- First submitted
- 25 Aug 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Cardiopulmonary Rehabilitation in Patients With Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07155421
- Acronym / sponsor ID
- bakircaymzeren09
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Saglik Bilimleri Universitesi, Yeditepe University
- Study start
- 10 Nov 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 4 Sep 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.
Acute decompensated heart failure (ADHF) is a severe condition characterized by rapid deterioration of cardiac function, leading to impaired oxygen delivery and multi-organ dysfunction. ADHF often results in reduced physical and respiratory capacity, greater dependence on oxygen support, difficulty performing daily activities, and prolonged hospital stays. In recent years, early exercise-based cardiopulmonary rehabilitation (CPR) has been introduced as part of heart failure management. Evidence suggests that early CPR improves overall health and cardiac function in heart failure patients. However, data regarding its effects in ADHF remain limited. While some studies indicate that early CPR enhances physical function, its impact on respiratory parameters and clinical outcomes is less well established.
Cardiopulmonary rehabilitation is a multidisciplinary program designed to promote physical, psychological, and social recovery in patients with cardiovascular and pulmonary diseases. It includes exercise training, education, psychosocial support, and behavioral strategies. Early CPR specifically aims to improve cardiovascular and respiratory functions in heart failure patients. Initiating CPR in the early phase of ADHF may accelerate recovery, strengthen cardiopulmonary function, shorten hospitalization, and improve quality of life.
This study aims to evaluate the effects of early CPR on functional capacity, hemodynamic parameters, and respiratory parameters in patients with ADHF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cardiopulmonary rehabilitation group | Experimental | Other: Early Cardiopulmonary Rehabilitation, Other: Routine in-hospital careExercise-based cardiopulmonary rehabilitation will be applied to this group during the hospital stay every day for 3 times a day. |
| Control Group | Other | Other: Routine in-hospital careRoutine in-hospital care will be applied to this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients hospitalized with a diagnosis of acute decompensated heart failure
- Being clinically stable
Key exclusion criteria (5 listed)
- Having diagnosed pulmonary, neurological, renal, liver, gastrointestinal, orthopedic or oncological pathologies
- Having cardiomyopathy or congestive pericarditis
- Recent heart surgery in the past 6 months
- New or suspected thromboembolic event
- Presence of open wounds, ulcerations or major dermatological diseases in the lower extremities
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 |
|---|---|---|
| Early Cardiopulmonary RehabilitationAn individualized CPR program including positioning, deep breathing exercises (diaphragmatic and segmental breathing exercises), pursed-lip breathing exercises, breathing exercises using incentive spirometry, and progressive mobilization exercises (in-bed range of motion exercises, sitting, standing, and walking exercises) | Other | Early cardiopulmonary rehabilitation group |
| Routine in-hospital careRoutine in-hospital care for acute decompansated heart failure | Other | Control Group, Early cardiopulmonary rehabilitation group |
Primary outcome
Functional capacity
Time frame: At baseline and at hospital discharge, up to 14 days after admission
It will be evaluated using 6-min walk test according to the guideline of American Thoracic Society
Physical performance
Time frame: At baseline and at hospital discharge, up to 14 days after admission
It will evaluated using Short Physical Performance Battery.
5 secondary outcomes
Maximum inspiratory and expiratory capacity
Time frame: At baseline and at hospital discharge, up to 14 days after admission
Hemodynamic responses to exercise
Time frame: At baseline and at hospital discharge, up to 14 days after admission
Hemodynamic responses to exercise
Time frame: At baseline and at hospital discharge, up to 14 days after admission
Hemodynamic responses to exercise
Time frame: At baseline and at hospital discharge, up to 14 days after admission
Subjective symptom responses to exercise
Time frame: At baseline and at hospital discharge, up to 14 days after admission
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 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Early Cardiopulmonary Rehabilitation and Routine in-hospital care in people with Heart Failure, run by Izmir Bakircay University 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 5 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 18 Jun 2026. 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?
Functional capacity (time frame: At baseline and at hospital discharge, up to 14 days after admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jun 2026.