Lymphatic Exercise for Heart Failure

Overseen By Elizabeth Cerceo, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Liver insufficiency, Kidney insufficiency, Malignant tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Lymphatic Exercise for Heart Failure?

Research shows that resistance exercise can improve oxygen uptake in heart failure patients without worsening heart function, and Tai Chi, a gentle exercise, can enhance walking distance and mood in heart failure patients. These findings suggest that exercise-based treatments like Lymphatic Exercise may benefit heart failure patients by improving physical capacity and quality of life. ^{1 2 3 4 5}

How is the treatment TOLF different from other treatments for heart failure?

The Optimal Lymph Flow (TOLF) is unique because it uses web- and mobile-based lymphatic exercises to help manage fluid overload in heart failure by promoting lymph flow, which is different from traditional heart failure treatments that often focus on medications and diet changes. ^{6 7 8 9 10}

Research Team

Rida Gharzeddine, PhD

Principal Investigator

Rutgers, The State University of New Jersery

Eligibility Criteria

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.

Inclusion Criteria

I have heart failure and experience mild to severe symptoms.

I am willing and able to follow a home-based program after leaving the hospital.

Exclusion Criteria

I do not have severe liver or kidney problems or cancer.

I am waiting for or have had a heart transplant.

You have a serious mental health condition like severe depression or thoughts of hurting yourself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments before randomization and discharge from the hospital

1 week

1 visit (in-person)

Treatment

Participants are randomly assigned to either TOLF + Daily Monitoring or Daily Monitoring only, with interventions lasting 4 weeks

4 weeks

1 visit (in-person), 3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with post-intervention data collection

1 week

1 visit (in-person)

Treatment Details

Interventions

• Daily Monitoring
• The Optimal Lymph Flow (TOLF)

Trial Overview 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.

Participant Groups

Group I: The Optimal Lymph Flow (TOLF) Experimental Treatment 2 Interventions

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

Group II: Daily Monitoring Active Control 1 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.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

The Cooper Health System

Collaborator

Trials

82

Recruited

35,600+

Findings from Research

In a study of 319 heart failure patients, a flattening oxygen consumption (VO2) trajectory during exercise tests was identified in 28.8% of participants and was associated with worse cardiac function, indicated by higher pulmonary artery systolic pressure and lower tricuspid annular plane systolic excursion.

The flattening VO2 trajectory was found to be a strong predictor of serious outcomes, such as all-cause death, heart transplantation, and hospitalization for cardiac reasons, making it a valuable tool for assessing disease severity and prognosis in heart failure patients regardless of ejection fraction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A flattening oxygen consumption trajectory phenotypes disease severity and poor prognosis in patients with heart failure with reduced, mid-range, and preserved ejection fraction. Popovic, D., Arena, R., Guazzi, M.[2019]

Resistance training (RT) significantly improves peak oxygen uptake ([Formula: see text] peak) more than aerobic exercise (AE) in heart failure patients, with an increase of 3.57 ml kg-1 min-1 for RT compared to 2.63 ml kg-1 min-1 for AE.

While RT enhances exercise capacity without negatively affecting cardiac function, AE is more effective in improving left ventricular ejection fraction (LVEF) and reducing left ventricular end-diastolic volume (LVEDV), indicating that both exercise types have unique benefits for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance exercise enhances oxygen uptake without worsening cardiac function in patients with systolic heart failure: a systematic review and meta-analysis. Santos, FV., Chiappa, GR., Ramalho, SHR., et al.[2019]

Tai chi (TC) is a safe and feasible exercise option for patients with heart failure with preserved ejection fraction (HFPEF), showing significant improvements in 6-minute walk distance and mood compared to aerobic exercise after 12 weeks.

While both tai chi and aerobic exercise improved overall quality of life and self-efficacy, tai chi led to a greater reduction in depression scores, indicating its potential psychological benefits in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tai chi in patients with heart failure with preserved ejection fraction. Yeh, GY., Wood, MJ., Wayne, PM., et al.[2021]

Survival rates for heart failure patients have significantly improved in the current era, with one-year survival increasing from 78% to 88% and two-year survival from 67% to 79% compared to the past era, highlighting the effectiveness of modern therapies.

The study suggests that the current criteria for heart transplantation eligibility, based on peak exercise oxygen consumption (VO2) and heart failure survival score (HFSS), may need to be re-evaluated due to these improved survival rates and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selection of patients for heart transplantation in the current era of heart failure therapy. Butler, J., Khadim, G., Paul, KM., et al.[2007]

A 67-year-old man with acute decompensated heart failure showed significant improvements in walking distance and cardiorespiratory response after 12 days of exercise training while receiving dobutamine therapy.

The exercise program, assessed using the 6-minute walk test, resulted in a 7% greater improvement in estimated peak oxygen consumption than expected from the medical therapy alone, indicating that exercise can be safely integrated into treatment for advanced heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case report: exercise in a patient with acute decompensated heart failure receiving positive inotropic therapy. Paul E H, R., Camarda, R., Foley, LL., et al.[2021]

The Optimal Lymph Flow (TOLF) system significantly reduced chronic pain and soreness in breast cancer survivors compared to the arm precaution (AP) control group, with 50% of TOLF participants achieving complete pain reduction.

TOLF also led to improvements in symptoms like arm/hand swelling and limited movement, while reducing the need for pain medications by 13%, indicating its effectiveness in managing lymphedema-related symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Fu, MR., Axelrod, D., Guth, AA., et al.[2023]

The Optimal-Lymph-Flow (TOLF) program significantly improved lymphedema symptoms, including the number and severity of symptoms, as well as their impact on daily activities, in breast cancer survivors compared to a control group.

Patients in the TOLF group had a lower incidence of significant arm volume differences (≥5%) at the study's end, indicating better management of lymphedema and suggesting that TOLF could be an effective early intervention in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies in activating lymphatic system to promote lymph flow on lymphedema symptoms in breast cancer survivors: A randomized controlled trial. Du, X., Li, Y., Fu, L., et al.[2022]

The Optimal Lymph Flow (TOLF) health IT system was highly accepted by breast cancer survivors, with 90% reporting no usability issues and 96.6% finding it easy to use and effective for learning about lymphedema management.

Qualitative feedback highlighted themes of empowerment and accessibility, indicating that TOLF successfully provides high-quality information and user-friendly features to support self-care strategies for lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and feasibility of health IT interventions to enhance Self-Care for Lymphedema Symptom Management in breast cancer survivors. Fu, MR., Axelrod, D., Guth, AA., et al.[2022]

A pilot study involving 66 heart failure patients showed that a 4-week exercise program designed to activate the lymphatic system (TOLF-HF) significantly reduced symptoms of fluid overload and abnormal weight gains.

The TOLF-HF program also led to notable improvements in physical functions, suggesting it could be a beneficial addition to standard care for managing heart failure symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercises in activating lymphatic system on fluid overload symptoms, abnormal weight gains, and physical functions among patients with heart failure: A randomized controlled trial. Li, Y., Meng, Q., Luo, B., et al.[2023]

The Kinect-TOLF intervention significantly reduced lymphatic pain, swelling, and lymphedema symptoms in 30 breast cancer survivors, demonstrating its effectiveness in managing these issues after just one training session.

Participants reported high satisfaction with the Kinect-TOLF program, which not only improved their symptoms but also effectively taught them the correct lymphatic exercises, indicating its feasibility and safety for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Kinect-Enhanced Lymphatic Exercise Intervention on Lymphatic Pain, Swelling, and Lymph Fluid Level. Fu, MR., McTernan, ML., Qiu, JM., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

A flattening oxygen consumption trajectory phenotypes disease severity and poor prognosis in patients with heart failure with reduced, mid-range, and preserved ejection fraction. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Resistance exercise enhances oxygen uptake without worsening cardiac function in patients with systolic heart failure: a systematic review and meta-analysis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Tai chi in patients with heart failure with preserved ejection fraction. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Selection of patients for heart transplantation in the current era of heart failure therapy. [2007]

5. United States pubmed.ncbi.nlm.nih.gov

Case report: exercise in a patient with acute decompensated heart failure receiving positive inotropic therapy. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

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. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Strategies in activating lymphatic system to promote lymph flow on lymphedema symptoms in breast cancer survivors: A randomized controlled trial. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Usability and feasibility of health IT interventions to enhance Self-Care for Lymphedema Symptom Management in breast cancer survivors. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Exercises in activating lymphatic system on fluid overload symptoms, abnormal weight gains, and physical functions among patients with heart failure: A randomized controlled trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The Effects of Kinect-Enhanced Lymphatic Exercise Intervention on Lymphatic Pain, Swelling, and Lymph Fluid Level. [2021]