Lymphatic System Stimulation and Fluid Overload Symptoms in Patients With Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Fluid Overload Symptoms
Study Overview
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 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
- if lymphatic exercise helped decrease symptoms associated with fluid overload like shortness of breath, lower leg swelling, and fatigue.
- if lymphatic exercises decreased thoracic fluid content and total body fluid level .
- if the lymphatic exercise helped improve sleep and quality of life (QOL).
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 gastrointestinal disturbance). Fluid overload symptoms are highly prevalent and burdensome, profoundly limiting patients' daily functioning and well-being. The occurrence or exacerbation of fluid overload symptoms is the major reason for patients with HF to be admitted or readmitted to hospital and causes patients' distress and poor QOL, imposing considerable burdens on the individual, family, and health care system.
The surveillance and management of worsening fluid overload symptoms is the cornerstone of HF care. Recent research on the role of lymphatic system in the pathogenesis of cardiovascular diseases has highlighted new therapeutic perspectives of fluid volume removal or fluid overload management in HF. If fluid is not drained at the same rate as it leaks, the painful and debilitating condition of fluid overload would develop. Prior work on lymphedema and symptoms related to lymph fluid accumulation in breast cancer patients showed efficacy in reduction of swelling, lymph fluid accumulation, reversed mild lymphedema, and improvement in pain severity, swelling severity, psychological distress, and QOL in these women. A recently published systematic review and meta-analysis summarizes data from 17 RCTs covering 1086 participants and demonstrated that peripheral muscle contracted exercises (e.g., aerobic exercises) can help to reduce the fluid overload symptom of dyspnea and edema. Thus, exercises focusing on optimizing lymph flow is a potential therapeutic approach to management of fluid overload symptoms in HF.
The specific aims of this study are to:
Aim1: Assess the feasibility and acceptability of lymphatic exercise training and obtaining data on fluid overload symptoms and body fluid level in adult patients with HF over training sessions. Feasibility will be assessed via (a) study accrual, (b) protocol adherence, and (c) retention.
Aim 2: Provide preliminary data for estimation of the effects of lymphatic exercise training on fluid overload symptoms and body fluid level at post-training compared to daily monitoring group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
The Optimal Lymph Flow (TOLF)
Participants in this arm perform lymphatic exercise training AND daily monitoring of fluid overload symptoms for 4 weeks
Intervention: The Optimal Lymph FLow (TOLF) (Behavioral)
The Optimal Lymph Flow (TOLF)
Participants in this arm perform lymphatic exercise training AND daily monitoring of fluid overload symptoms for 4 weeks
Intervention: Daily Monitoring (Behavioral)
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.
Intervention: Daily Monitoring (Behavioral)
Outcomes
Primary Outcomes
Fluid Overload Symptoms
Time Frame: 4 weeks
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.
Body Fluid Content
Time Frame: 4 weeks
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.
Thoracic Fluid Content
Time Frame: 4 weeks
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
Secondary Outcomes
- Sleep Quality(4 weeks)
- Health related Quality of Life(4 weeks)
- Insomnia Severity(4 weeks)
- Daytime sleepiness(4 weeks)
Investigators
Rida Gharzeddine, PhD, RN
Assistant Professor
Rutgers, The State University of New Jersey