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Lymphatic Exercise for Heart Failure
N/A
Recruiting
Led By Rida Gharzeddine, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of HF with New York Heart Association (NYHA) functional class II, III, or IV
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Study Summary
This trial will study if lymphatic exercise can help reduce symptoms and improve sleep and quality of life in patients with heart failure.
Who is the study for?
This trial is for heart failure patients who can do a home-based exercise program and are in NYHA class II-IV. It's not for pregnant individuals, those with severe liver or kidney issues, cancer, serious mental health conditions, less than 6 months to live, awaiting heart transplant, or cognitive impairments like dementia.Check my eligibility
What is being tested?
The study tests if lymphatic exercises can reduce fluid overload symptoms (like breathlessness and swelling), lower thoracic and body fluid levels, and improve sleep and life quality in heart failure patients. One group does the exercises along with daily monitoring; the other only monitors without exercising.See study design
What are the potential side effects?
Since this trial involves non-drug interventions such as exercise training and daily monitoring of vital signs, side effects may be minimal but could include muscle soreness or fatigue from the new physical activities.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have heart failure and experience mild to severe symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Fluid Content
Fluid Overload Symptoms
Thoracic Fluid Content
Secondary outcome measures
Daytime sleepiness
Health related Quality of Life
Insomnia Severity
+1 moreOther outcome measures
Number of abnormal weight fluctuations
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: The Optimal Lymph Flow (TOLF)Experimental Treatment2 Interventions
Participants in this arm perform lymphatic exercise training AND daily monitoring of fluid overload symptoms for 4 weeks
Group II: Daily MonitoringActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daily Monitoring
2020
N/A
~30
Find a Location
Who is running the clinical trial?
Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,152 Total Patients Enrolled
1 Trials studying Heart Failure
320 Patients Enrolled for Heart Failure
The Cooper Health SystemOTHER
76 Previous Clinical Trials
33,033 Total Patients Enrolled
1 Trials studying Heart Failure
1,001 Patients Enrolled for Heart Failure
Rida Gharzeddine, PhDPrincipal InvestigatorRutgers, The State University of New Jersery
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe liver or kidney problems or cancer.I have heart failure and experience mild to severe symptoms.I am waiting for or have had a heart transplant.I am willing and able to follow a home-based program after leaving the hospital.You have a serious mental health condition like severe depression or thoughts of hurting yourself.I cannot communicate in English.My doctor expects I have less than 6 months to live.You have trouble thinking clearly, such as with memory or understanding.
Research Study Groups:
This trial has the following groups:- Group 1: The Optimal Lymph Flow (TOLF)
- Group 2: Daily Monitoring
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What aims is this research attempting to fulfill?
"This four-week trial will primarily measure Thoracic Fluid Content but also evaluate Sleep Quality based on the Pittsburgh Sleep Quality Index, Insomnia Severity through the use of the Insomnia Severity Index and Daytime sleepiness with The Epworth Sleepiness Scale."
Answered by AI
Is eligibility for this study confined to those aged 18 and over?
"This study requires potential participants to be of legal age and under 80 years old."
Answered by AI
Who is eligible to register for this experiment?
"To be eligible to join this clinical trial, participants must possess a diagnosis of heart failure and should fall within the age range of 18-80 years old. Currently, 80 patients are needed for recruitment."
Answered by AI
Are there any vacancies available for potential participants in this clinical trial?
"The clinicaltrials.gov database indicates that this trial, first posted on May 1st 2023, is not actively seeking participants. As of now, 721 other studies are looking for people to participate in their research."
Answered by AI
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