Lymphatic System Stimulation in Heart Failure

Part of paid clinical trials in Camden, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT05834400
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

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.
  • 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

Study Details

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).

Key Dates

First listed
Apr 28, 2023
Start date
Aug 15, 2023
Status verified
Apr 2026
Primary completion
Sep 30, 2025
Completion
Nov 30, 2025

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: The Optimal Lymph Flow (TOLF)
    Participants in this arm perform lymphatic exercise training AND daily monitoring of fluid overload symptoms for 4 weeks
  • Active Comparator: Daily Monitoring
    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.

Primary Outcome Measure

Fluid Overload Symptoms [ Time Frame: 4 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cooper University Health Care (Cooper)CamdenNew Jersey08103-

Find similar trials in Camden, NJ

Nationwide
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By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Cooper University Health Care (Cooper)· Camden, NJ

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