Effects of In-Hospital Cardiac Rehabilitation and Manual Lymphatic Drainage in Acute Decompensated Heart Failure

NCT07095764 — Not applicable, Completed, 40 participants, Izmir Bakircay University

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Registry	NCT07095764
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	40 (Actual)
Sponsor	Izmir Bakircay University (Other); collaborators: Istanbul University - Cerrahpasa, Yeditepe University, Saglik Bilimleri Universitesi
Conditions	Acute Decompensated Heart Failure
Interventions	Manual Lymphatic Drainage, Cardiac Rehabilitation (Other)
Dates	start 2025-08-12, primary completion 2025-12-01, completion 2025-12-01, first posted 2025-07-31, last updated 2025-12-23
Locations	1 site in Turkey (Türkiye)

-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 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.

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+Arms and interventions

Arm	Type	Interventions	Description
Manual Lymphatic Drainage + Cardiac Rehabilitation Group	Experimental	Other: Manual Lymphatic Drainage; Other: Cardiac Rehabilitation	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.
Cardiac Rehabilitation Group	Active comparator	Other: Cardiac Rehabilitation	Exercise based cardiac rehabilitation will be applied to this group during the hospital stay every day for 3 times a day.

Manual Lymphatic Drainage (Other): 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 Rehabilitation (Other): 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.

+Outcome measures

Primary outcomes

Lower extremity edema [At baseline and at hospital discharge, up to 14 days after admission]: Lower extremity edema will be evaluated by circumference measurement
Lower extremity edema [At baseline and at hospital discharge, up to 14 days after admission]: Lower extremity edema will be evaluated by pitting test
Functional capacity [At baseline and at hospital discharge, up to 14 days after admission]: Functional capacity will be measured using 6-min Walk Test.

Secondary outcomes

Health-related quality of life [At baseline and at hospital discharge, up to 14 days after admission]: 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.

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

* Patients hospitalized with a diagnosis of acute decompensated heart failure
* Being clinically stable

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Istanbul University- Cerrahpasa, Cardiology Institute	Istanbul	Turkey (Türkiye)