MedDataX Logo

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

NCT ID: NCT07095764

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-12

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Decompensated Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Manual Lymphatic Drainage + Cardiac Rehabilitation Group

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.

Group Type EXPERIMENTAL

Manual Lymphatic Drainage

Intervention Type 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

Intervention Type 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

Exercise based cardiac rehabilitation will be applied to this group during the hospital stay every day for 3 times a day.

Group Type ACTIVE_COMPARATOR

Cardiac Rehabilitation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Manual Lymphatic Drainage

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.

Intervention Type OTHER

Cardiac Rehabilitation

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Yeditepe University

OTHER

Sponsor Role collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role collaborator

Izmir Bakircay University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Melih Zeren

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University- Cerrahpasa, Cardiology Institute

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

bakircaymzeren08

Identifier Type: -

Identifier Source: org_study_id