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Clinical Trial NCT05834400 for Heart Failure is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Lymphatic System Stimulation in Heart Failure 80 Exercise-Based
Clinical Trial NCT05834400 is an interventional study for Heart Failure that is recruiting. It started on 15 June 2023 with plans to enroll 80 participants. Led by Rutgers, The State University of New Jersey, it is expected to complete by 1 October 2025. The latest data from ClinicalTrials.gov was last updated on 28 October 2024.
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:
- Does performing lymphatic exercise decrease fluid overload symptoms (shortness of breath, lower legs swelling, fatigue), thoracic fluid content, and body fluid level?
- Does performing lymphatic exercise improve sleep and q...
Detailed Description
Heart failure (HF) is a growing public health problem affecting 6.2 million people in the United States. Fluid overload, the hallmark of HF, refers to a progressive body fluid retention or redistribution that impedes multiple body system functions and leads to symptoms of pulmonary congestion (e.g., dyspnea, orthopnea, coughing, or wheezing) and systemic venous congestion (e.g., edema, fatigue, bodily pain, and gastr...Show More
Official Title
Lymphatic System Stimulation and Fluid Overload Symptoms in Patients With Heart Failure
Conditions
Heart FailurePublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- Pro2022001875
NCT ID Number
Start Date (Actual)
2023-06-15
Last Update Posted
2024-10-28
Completion Date (Estimated)
2025-10
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Heart failure
Cardiac Edema
Self-care
Exercise Movement Techniques
Cardiac Edema
Self-care
Exercise Movement Techniques
Primary Purpose
Supportive Care
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalThe Optimal Lymph Flow (TOLF) Participants in this arm perform lymphatic exercise training AND daily monitoring of fluid overload symptoms for 4 weeks | 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 ...Show More 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 |
Active ComparatorDaily 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. | 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Health related Quality of Life | Will be measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The Minnesota Living with Heart Failure Questionnaire (MLHFQ) provides a total score (range 0-105), with higher scores indicating worse quality of life | 4 weeks |
Sleep Quality | Sleep quality is measured with the Pittsburgh Sleep Quality Index (PSQI). The scores are summed to yield a total score ranging from 0 to 21, with the higher total score (referred to as global score) indicating worse sleep quality. | 4 weeks |
Insomnia Severity | Insomnia severity is measured by Insomnia Severity Index (ISI). Total score ranges from 0-28 with higher scores indicating worse insomnia severity. | 4 weeks |
Daytime sleepiness | Daytime sleepiness is measured by The Epworth Sleepiness Scale (ESS) where the total score ranges from 0-24. Scores of 11-24 represent increasing levels of 'excessive daytime sleepiness. | 4 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Rutgers, The State University of New JerseyThe Cooper Health SystemStudy Responsible Party
Rida Gharzeddine, PhD, RN, Principal Investigator, Assistant Professor, Rutgers, The State University of New Jersey
Study Central Contact
Contact: Rida Gharzeddine, PhD, 2016570912, [email protected]
Contact: Elizabeth Cerceo, MD, 856-577-8975, [email protected]
1 Study Locations in 1 Countries
New Jersey
Cooper University Health Care (Cooper), Camden, New Jersey, 08103, United States
Elizabeth Cerceo, MD, Contact, 856-577-8975, [email protected]
Amine Al Soueidy, MD, Contact, 267-694-4645, [email protected]
Recruiting