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

NCT07095764 | Completed

• 1 other identifier: bakircaymzeren08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Decompensated Heart Failure

Outcome Measures

Primary Outcomes (3)

• Lower extremity edema

  Lower extremity edema will be evaluated by circumference measurement

  At baseline and at hospital discharge, up to 14 days after admission

• Lower extremity edema

  Lower extremity edema will be evaluated by pitting test

  At baseline and at hospital discharge, up to 14 days after admission

• Functional capacity

  Functional capacity will be measured using 6-min Walk Test.

  At baseline and at hospital discharge, up to 14 days after admission

Secondary Outcomes (1)

• Health-related quality of life

  At baseline and at hospital discharge, up to 14 days after admission

Study Arms (2)

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.

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.

Other: Cardiac Rehabilitation

Interventions

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.

Cardiac Rehabilitation Group; Manual Lymphatic Drainage + Cardiac Rehabilitation Group

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.

Manual Lymphatic Drainage + Cardiac Rehabilitation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Izmir Bakircay University: lead
• Istanbul University - Cerrahpasa: collaborator
• Yeditepe University: collaborator
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

Istanbul University- Cerrahpasa, Cardiology Institute

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Manual Lymphatic Drainage; Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: July 31, 2025
• Study Start: August 12, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-06

Locations

TU (1)