Acute Decompensated Heart FailureNCT07095764
Effects of In-Hospital Cardiac Rehabilitation and Manual Lymphatic Drainage in Acute Decompensated Heart Failure
A study testing Manual Lymphatic Drainage and Cardiac Rehabilitation in people with Acute Decompensated Heart Failure, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
Heart failure is a major global health issue requiring effective interventions to enhance patients' physical function and quality of life. Cardiac rehabilitation, particularly when started early during hospitalization for acute decompensated heart failure, has been shown to improve cardiovascular function, reduce… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Decompensated Heart Failure
- What is being tested?
- Manual Lymphatic Drainage and Cardiac Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2025to 1 Dec 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 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
Heart failure is a major global health issue requiring effective interventions to enhance patients' physical function and quality of life. Cardiac rehabilitation, particularly when started early during hospitalization for acute decompensated heart failure, has been shown to improve cardiovascular function, reduce hospital readmissions, and boost recovery. In-hospital exercise training enhances physical capacity, strengthens heart function, and alleviates physical limitations. On the other hand, lymphatic dysfunction in heart failure may also contribute to fluid retention, worsening the symptoms including lower extremity edema. Manual lymphatic drainage is considered a safe method to reduce edema and support fluid balance. This study aims to evaluate effects of in-hospital cardiac rehabilitation and manual lymphatic drainage on fluid overload symptoms and functional capacity in patients with acute decompensated heart failure.
- Conditions
- Acute Decompensated Heart Failure
- Being tested
- Manual Lymphatic Drainage, Cardiac Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic DrainageOther
Specific manual lymph drainage techniques including stationary circles, rotary circles, pumping, and scooping will be applied to both lower extremities using gentle, rhythmic skin movements in accordance with the direction of the lymphatic flow.
Cardiac RehabilitationOther
An individualized program consists of progressive, low-intensity exercises including respiratory exercises, range of motion exercises for major joints, postural exercises, flexibility exercises, and gradual mobilization exercises such as sitting and walking will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Manual Lymphatic Drainage + Cardiac Rehabilitation Group | Experimental | Manual lymphatic drainage and exercise based cardiac rehabilitation will be applied to this group during the hospital stay every day for 3 times a day. Receives: Other: Manual Lymphatic Drainage; Other: Cardiac Rehabilitation |
| Cardiac Rehabilitation Group | Active comparator | Exercise based cardiac rehabilitation will be applied to this group during the hospital stay every day for 3 times a day. Receives: Other: Cardiac Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity edema
Lower extremity edema will be evaluated by circumference measurement
Measured: At baseline and at hospital discharge, up to 14 days after admission
Lower extremity edema
Lower extremity edema will be evaluated by pitting test
Measured: At baseline and at hospital discharge, up to 14 days after admission
Functional capacity
Functional capacity will be measured using 6-min Walk Test.
Measured: At baseline and at hospital discharge, up to 14 days after admission
Secondary outcomes (1)
Health-related quality of life
Health-related quality of life will be evaluted using Short-Form 12 Questionnaire. It is scored between 0-100 and higher scores indicate better quality of life.
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 posted31 Jul 2025
- Study start12 Aug 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Decompensated 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Yeditepe University, Saglik Bilimleri Universitesi
- Responsible party
- Principal investigator, Melih Zeren, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095764
- Sponsor's protocol ID
- bakircaymzeren08
- Status last verified
- Jun 2025
- First submitted
- 19 Jun 2025
- Last updated
- 23 Dec 2025
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of In-Hospital Cardiac Rehabilitation and Manual Lymphatic Drainage in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT07095764
- Acronym / sponsor ID
- bakircaymzeren08
- Conditions
- Acute Decompensated Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, Yeditepe University, Saglik Bilimleri Universitesi
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 31 Jul 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.
Heart failure is a major global health issue requiring effective interventions to enhance patients' physical function and quality of life. Cardiac rehabilitation, particularly when started early during hospitalization for acute decompensated heart failure, has been shown to improve cardiovascular function, reduce hospital readmissions, and boost recovery. In-hospital exercise training enhances physical capacity, strengthens heart function, and alleviates physical limitations. On the other hand, lymphatic dysfunction in heart failure may also contribute to fluid retention, worsening the symptoms including lower extremity edema. Manual lymphatic drainage is considered a safe method to reduce edema and support fluid balance. This study aims to evaluate effects of in-hospital cardiac rehabilitation and manual lymphatic drainage on fluid overload symptoms and functional capacity in patients with acute decompensated heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage + Cardiac Rehabilitation Group | Experimental | Other: Manual Lymphatic Drainage, Other: Cardiac RehabilitationManual lymphatic drainage and exercise based cardiac rehabilitation will be applied to this group during the hospital stay every day for 3 times a day. |
| Cardiac Rehabilitation Group | Active comparator | Other: Cardiac RehabilitationExercise based cardiac rehabilitation will be applied to this group during the hospital stay every day for 3 times a day. |
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 |
|---|---|---|
| Manual Lymphatic DrainageSpecific manual lymph drainage techniques including stationary circles, rotary circles, pumping, and scooping will be applied to both lower extremities using gentle, rhythmic skin movements in accordance with the direction of the lymphatic flow. | Other | Manual Lymphatic Drainage + Cardiac Rehabilitation Group |
| Cardiac RehabilitationAn individualized program consists of progressive, low-intensity exercises including respiratory exercises, range of motion exercises for major joints, postural exercises, flexibility exercises, and gradual mobilization exercises such as sitting and walking will be applied. | Other | Cardiac Rehabilitation Group, Manual Lymphatic Drainage + Cardiac Rehabilitation Group |
Primary outcome
Lower extremity edema
Time frame: At baseline and at hospital discharge, up to 14 days after admission
Lower extremity edema will be evaluated by circumference measurement
Lower extremity edema
Time frame: At baseline and at hospital discharge, up to 14 days after admission
Lower extremity edema will be evaluated by pitting test
Functional capacity
Time frame: At baseline and at hospital discharge, up to 14 days after admission
Functional capacity will be measured using 6-min Walk Test.
1 secondary outcome
Health-related quality of life
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 23 Dec 2025.
- 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 Manual Lymphatic Drainage and Cardiac Rehabilitation in people with Acute Decompensated 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 23 Dec 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?
Lower extremity edema (time frame: At baseline and at hospital discharge, up to 14 days after admission). The study lists 3 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 23 Dec 2025.