Lymphatic System Stimulation in Heart Failure

NCT05834400 | Completed DMC

• 1 other identifier: Pro2022001875
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to obtain preliminary data on the effects of lymphatic exercise training in patients with heart failure. The main question\[s\] it aims to answer are:

1. 1.Does performing lymphatic exercise decrease fluid overload symptoms (shortness of breath, lower legs swelling, fatigue), thoracic fluid content, and body fluid level?
2. 2.Does performing lymphatic exercise improve sleep and quality of life (QOL)?
3. 3.if lymphatic exercise helped decrease symptoms associated with fluid overload like shortness of breath, lower leg swelling, and fatigue.
4. 4.if lymphatic exercises decreased thoracic fluid content and total body fluid level .
5. 5.if the lymphatic exercise helped improve sleep and quality of life (QOL).

Conditions

Heart Failure

Keywords

Heart failure; Cardiac Edema; Self-care; Exercise Movement Techniques

Outcome Measures

Primary Outcomes (3)

• Fluid Overload Symptoms

  Fluid overload symptoms include shortness of breath, difficulty breathing when lying flat, cough, lack of energy, swelling of legs or ankles, and waking up breathless at nigh swelling of the lower extremities. These symptoms are measured by The Memorial Symptom Assessment Scale - Heart Failure (MSAS-HF). Individual scores are summed for each symptom present, rating frequency, severity, and distress to obtain a total symptom score for each symptom with a possible range of 0-13. Higher scores indicate greater symptom burden.

  4 weeks

• Thoracic Fluid Content

  Will be assessed by the FDA approved, non-invasive remote dielectric sensing (ReDS) (Sensible Medical Innovations, Ltd, Israel). ReDS uses low-power electromagnetic signals emitted between 2 sensors (1 each on the anterior and posterior body surfaces) embedded in a wearable vest

  4 weeks

• Body Fluid Content

  Will be measured by stand-on bioimpedance analysis (BIA) device (InBody 570, Biospace Co., Ltd., Cerritos, CA, USA). Intracellular and extracellular fluid levels are measured to determine total body fluid levels. These measures will be combined to determine the ratio of extracellular fluid to the total body fluid to indicate whether body fluids are balanced. Normal ratios range from 0.36 to 0.39, and higher ratios are indicative of fluid retention and edema.

  4 weeks

Secondary Outcomes (4)

• Health related Quality of Life

  4 weeks

• Sleep Quality

  4 weeks

• Insomnia Severity

  4 weeks

• Daytime sleepiness

  4 weeks

Other Outcomes (1)

• Number of abnormal weight fluctuations

  4 weeks

Study Arms (2)

The Optimal Lymph Flow (TOLF)

EXPERIMENTAL

Participants in this arm perform lymphatic exercise training AND daily monitoring of fluid overload symptoms for 4 weeks

Behavioral: The Optimal Lymph FLow (TOLF); Behavioral: Daily Monitoring

Daily Monitoring

ACTIVE COMPARATOR

Participants in this arm will only perform daily monitoring of fluid overload symptoms including weight, heart rate, and blood pressure for 4 weeks. Participants will NOT perform TOLF in this arm.

Behavioral: Daily Monitoring

Interventions

The Optimal Lymph FLow (TOLF) BEHAVIORAL

Participants in TOLF intervention will complete initial in-person 40-minute session on TOLF lymphatic exercise training and daily monitoring, and 3 virtual 15-minute telehealth sessions to enhance their skills over the course of 4 weeks. These sessions will be conducted by the TOLF interventionist of the study. For 4-week study duration, participants will be asked to practice the set of 8 lymphatic exercises twice a day.

The Optimal Lymph Flow (TOLF)

Daily Monitoring BEHAVIORAL

Participants will complete initial in-person training on daily monitoring of weight, heart rate and blood pressure, fluid overload symptoms; and 3 conferencing coaching sessions conducted by the monitoring coach to enhance their skills. Over the course of 4 weeks, Participants will monitor these daily fluid overload parameters and symptoms

Daily Monitoring; The Optimal Lymph Flow (TOLF)

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of HF with New York Heart Association (NYHA) functional class II, III, or IV
• Willing and able to complete the home-based TOLF program upon discharge from the hospital to home

You may not qualify if:

• Severe liver or kidney insufficiency or malignant tumors
• A terminal condition with a life expectancy of \< 6 months
• Received or waiting for heart transplantation
• Pregnancy
• Cognitive impairment (e.g., dementia)
• Severe psychiatric condition (psychotic disorder, severe depression, suicidal intent)
• Inability to converse in English

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• The Cooper Health System: collaborator

Study Sites (1)

Cooper University Health Care (Cooper)

Camden, New Jersey, 08103, United States

Location

Related Publications (3)

• Fu MR, Li Y, Conway C, Masone A, Fang J, Lee C. The Effects of Exercise-Based Interventions on Fluid Overload Symptoms in Patients with Heart Failure: A Systematic Review and Meta-Analysis. Biomedicines. 2022 May 11;10(5):1111. doi: 10.3390/biomedicines10051111.

  PMID: 35625848 BACKGROUND

• Liu F, Li F, Fu MR, Zhao Q, Wang Y, Pang D, Yang P, Jin S, Lu Q. Self-management Strategies for Risk Reduction of Subclinical and Mild Stage of Breast Cancer-Related Lymphedema: A Longitudinal, Quasi-experimental Study. Cancer Nurs. 2021 Nov-Dec 01;44(6):E493-E502. doi: 10.1097/NCC.0000000000000919.

  PMID: 34694088 BACKGROUND

• Fu MR, Axelrod D, Guth AA, Scagliola J, Rampertaap K, El-Shammaa N, Qiu JM, McTernan ML, Frye L, Park CS, Yu G, Tilley C, Wang Y. A Web- and Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial. JMIR Cancer. 2022 Jan 17;8(1):e29485. doi: 10.2196/29485.

  PMID: 35037883 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Edema, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Edema; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rida Gharzeddine, PhD

  Rutgers, The State University of New Jersery

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants are randomly assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 28, 2023
• Study Start: August 15, 2023
• Primary Completion: September 30, 2025
• Study Completion: November 30, 2025
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)