Lymphatic System Stimulation in Heart Failure

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. Does performing lymphatic exercise decrease fluid overload symptoms (shortness of breath, lower legs swelling, fatigue), thoracic fluid content, and body fluid level?
2. Does performing lymphatic exercise improve sleep and quality of life (QOL)?

Participants with heart failure will be randomly assigned into two groups:

Group 1 will receive training on lymphatic exercises, and will perform these training for 4 weeks. This group will also be trained to monitor daily their weight, heart rate and blood pressure, and fluid overload symptoms.

Group 2 will be trained to daily monitor their weight, heart rate and blood pressure, and fluid overload symptoms. This group will not perform the lymphatic exercises.

Researchers will compare the two groups at the baseline and after delivering the 4 week-interventions to see

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

Conditions

• Heart Failure

Interventions

BEHAVIORAL

The Optimal Lymph FLow (TOLF)

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.

BEHAVIORAL

Daily Monitoring

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

Sponsors & Collaborators

• The Cooper Health System

  collaborator OTHER

• Rutgers, The State University of New Jersey

  lead OTHER

Principal Investigators

• Rida Gharzeddine, PhD · Rutgers, The State University of New Jersery

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-15

Primary Completion

2025-09-30

Completion

2025-11-30

Countries

• United States

Study Locations