Ignite Creation Date:
2024-05-06 @ 6:56 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05834400
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2023-04-03
Brief Title:
Lymphatic System Stimulation in Heart Failure
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Lymphatic System Stimulation and Fluid Overload Symptoms in Patients With Heart Failure
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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
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
Detailed Description:
Heart failure HF is a growing public health problem affecting 62 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 eg dyspnea orthopnea coughing or wheezing and systemic venous congestion eg 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 eg 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
Aim 3 Explore the effects of lymphatic exercise training on sleep quality of life QOL and he number of abnormal weight fluctuations at post-training compared to daily monitoring group
Research Design and Methods Design We will use a prospective Randomized Controlled Trial RCT design to assess the feasibility acceptability and outcome patterns suggesting efficacy of a TOLF Lymphatic Exercise Training for Fluid Overload Symptom Management protocol This study will be conducted at the Cooper University Health Care Cooper with 80 adult HF patients
Study Population Patients aged 18 to 80 years hospitalized due to fluid overload with a primary diagnosis of HF in the chronic or stable phase
Research Procedures A total of 80 participants will be recruited Following consent and baseline assessment 80 participants will be randomly assigned in equal allocation to one of two conditions 1 TOLF Daily Monitoring DM or 2 DM Our research evaluator will not be involved in recruitment or have other contact with participants they will be blinded to participant randomization and conduct all study procedures where blinding is indicated eg assessments Additionally all efforts will be made for study staff and participants to be blinded to participant condition
Recruitment and Informed Consent All recruitment procedures will comply with HIPAA guidelines The recruitment procedure will be as follows Potential participants will be identified through electronic medical record review or their medical team Once a potential participant has been identified their primary physician will be contacted for permission to attempt to recruit the participant for this study If the physician agrees potential participants will be told about the study by a member of the medical staff and asked if they would be willing to talk with a member of the study team Once a potential subject agrees a member of the study team at Cooper will approach the patient At this time the member of the study team will describe the study in detail provide the patient with consent forms and offer to answer any questions about the study Once a patient has consented they will complete the first study assessment before heshe discharged from the hospital to home
RCT Randomization Following consent and baseline assessment 80 participants will be randomly assigned in equal allocation to one of two conditions 1 TOLF Daily Monitoring DM or 2 DM Randomization will be blocked by NYHA functional class II III IV and gender to ensure reasonable balance in each treatment condition The data programmer on this study who is not involved with recruitment will randomly draw a number of 1 or 2 to be given the participants study number not name to randomize the participant Our research evaluator will not be involved in recruitment or have other contact with participants they will be blinded to participant randomization and conduct all study procedures where blinding is indicated eg assessments Additionally all efforts will be made for study staff and nurses and physicians to be blinded to participant condition Participants who do not have a smartphone will be loaned a cellular phone with Internet access to the mHealth features video-conferencing fluid overload symptom management skill content TOLF lymphatic exercise videos
Treatment Conditions It is expected that participants either in TOLFDM or DM groups will complete initial in-person 40-minute session and 3 virtual 15-minute telehealth video-sessions over the course of 4 weeks
Daily Monitoring DM Participants will complete initial in-person training on daily monitoring of weight heart rate and blood pressure fluid overload symptoms and 3 video-conferencing coaching sessions conducted by the monitoring coach to enhance their skills
The-Optimal-Lymph-Flow TOLF Patients 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 video-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
Therapist Training TOLF and DM skills training sessions will be delivered by nurses with experience working with HF patients Treatment strategies will be taught through didactic instruction audio-video-recorded illustration of techniques and role-play
Procedures to Ensure Consistency of TOLF Treatment To ensure consistency with the intervention protocol 1 therapist will follow a treatment manual 2 weekly supervision will occur 3 sessions will be audio-recorded and reviewed during supervision and feedback provided and 4 ratings of treatment adherence and competence will be conducted
Timing and Frequency of data collection
Demographics and baseline data will be collected in Cooper University Health Care Cooper Cardiac Unit before patients are discharged Participants will be asked for a research visit to Cooper University Health Care Cooper on week 5 to collect post intervention data
During the intervention duration participants will be asked to text their weight heart rate and blood pressure daily and keep a daily log that will bring with them on week 5 Research Staff Training Research evaluator The research evaluator will be a recruited nurse who will collect self-reported and objective data from participants Research evaluator data collector will be trained on how to ask and explain questions in the questionnaires and how to use objective devices to collect objective data on fluid content and level Training will include didactic instruction audio-video-recorded illustration of techniques and role-play Therapist Training TOLF and DM skills training sessions will be delivered by two research assistant nurses who had experience working with HF patients One therapist will be the interventionist and the second will be the monitoring coach to avoid contamination Treatment strategies will be taught through didactic instruction audio-video-recorded illustration of techniques and role-play
Procedures to Ensure Consistency of TOLF Treatment To ensure consistency with the intervention protocol 1 therapist will follow a treatment manual 2 weekly supervision will occur 3 sessions will be audio-recorded and reviewed during supervision and feedback provided and 4 ratings of treatment adherence and competence will be conducted
Data Analysis Aim 1 Analyses Feasibility will be assessed by examining accrual adherence and attrition Accrual will be indicated by meeting the recruitment goal of 80 participants in 24 months Descriptive statistics will be reported on the number of HF patients screened and determine rates of non-eligibility and refusal Adherence will be indicated by calculating the proportion successfully completing all intervention sessions within the TOLFDM arm and the proportion completing post-treatment assessments within each arm 80 completed intervention sessions and 80 completed assessments will serve as our feasibility benchmark With a sample size of 50 we will be able to estimate a rate of 80 to within the 95 confidence interval width of - 11 So if less than 69 of participants complete all intervention sessions and assessments TOLFDM will not be considered feasible Attrition will be indicated by 80 of consented participants completing the study protocol ie remain enrolled Acceptability will be indicated by 80 of patients reporting satisfaction with TOLFDM Mean7 on the CSQ Aim 2 3 Analyses Between-group effect sizes will be used to evaluate treatment effects on fluid overload symptoms TFCI body fluid level hospital readmission the number of abnormal weight fluctuations and QOL Between-group effect sizes will provide an index of relative change for TOLFDM participants vs DM participants Because small samples can differ on pretest scores effect sizes will be calculated by first creating change scores for each person The between-group effect size will then be calculated by subtracting the average DM group change score from the average TOLDDM change score and dividing this difference by the standard deviation of the pooled treatmentcontrol groups change score This study is not designed to make conclusions about efficacy without further study
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 eg 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
Aim 3 Explore the effects of lymphatic exercise training on sleep quality of life QOL and he number of abnormal weight fluctuations at post-training compared to daily monitoring group
Research Design and Methods Design We will use a prospective Randomized Controlled Trial RCT design to assess the feasibility acceptability and outcome patterns suggesting efficacy of a TOLF Lymphatic Exercise Training for Fluid Overload Symptom Management protocol This study will be conducted at the Cooper University Health Care Cooper with 80 adult HF patients
Study Population Patients aged 18 to 80 years hospitalized due to fluid overload with a primary diagnosis of HF in the chronic or stable phase
Research Procedures A total of 80 participants will be recruited Following consent and baseline assessment 80 participants will be randomly assigned in equal allocation to one of two conditions 1 TOLF Daily Monitoring DM or 2 DM Our research evaluator will not be involved in recruitment or have other contact with participants they will be blinded to participant randomization and conduct all study procedures where blinding is indicated eg assessments Additionally all efforts will be made for study staff and participants to be blinded to participant condition
Recruitment and Informed Consent All recruitment procedures will comply with HIPAA guidelines The recruitment procedure will be as follows Potential participants will be identified through electronic medical record review or their medical team Once a potential participant has been identified their primary physician will be contacted for permission to attempt to recruit the participant for this study If the physician agrees potential participants will be told about the study by a member of the medical staff and asked if they would be willing to talk with a member of the study team Once a potential subject agrees a member of the study team at Cooper will approach the patient At this time the member of the study team will describe the study in detail provide the patient with consent forms and offer to answer any questions about the study Once a patient has consented they will complete the first study assessment before heshe discharged from the hospital to home
RCT Randomization Following consent and baseline assessment 80 participants will be randomly assigned in equal allocation to one of two conditions 1 TOLF Daily Monitoring DM or 2 DM Randomization will be blocked by NYHA functional class II III IV and gender to ensure reasonable balance in each treatment condition The data programmer on this study who is not involved with recruitment will randomly draw a number of 1 or 2 to be given the participants study number not name to randomize the participant Our research evaluator will not be involved in recruitment or have other contact with participants they will be blinded to participant randomization and conduct all study procedures where blinding is indicated eg assessments Additionally all efforts will be made for study staff and nurses and physicians to be blinded to participant condition Participants who do not have a smartphone will be loaned a cellular phone with Internet access to the mHealth features video-conferencing fluid overload symptom management skill content TOLF lymphatic exercise videos
Treatment Conditions It is expected that participants either in TOLFDM or DM groups will complete initial in-person 40-minute session and 3 virtual 15-minute telehealth video-sessions over the course of 4 weeks
Daily Monitoring DM Participants will complete initial in-person training on daily monitoring of weight heart rate and blood pressure fluid overload symptoms and 3 video-conferencing coaching sessions conducted by the monitoring coach to enhance their skills
The-Optimal-Lymph-Flow TOLF Patients 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 video-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
Therapist Training TOLF and DM skills training sessions will be delivered by nurses with experience working with HF patients Treatment strategies will be taught through didactic instruction audio-video-recorded illustration of techniques and role-play
Procedures to Ensure Consistency of TOLF Treatment To ensure consistency with the intervention protocol 1 therapist will follow a treatment manual 2 weekly supervision will occur 3 sessions will be audio-recorded and reviewed during supervision and feedback provided and 4 ratings of treatment adherence and competence will be conducted
Timing and Frequency of data collection
Demographics and baseline data will be collected in Cooper University Health Care Cooper Cardiac Unit before patients are discharged Participants will be asked for a research visit to Cooper University Health Care Cooper on week 5 to collect post intervention data
During the intervention duration participants will be asked to text their weight heart rate and blood pressure daily and keep a daily log that will bring with them on week 5 Research Staff Training Research evaluator The research evaluator will be a recruited nurse who will collect self-reported and objective data from participants Research evaluator data collector will be trained on how to ask and explain questions in the questionnaires and how to use objective devices to collect objective data on fluid content and level Training will include didactic instruction audio-video-recorded illustration of techniques and role-play Therapist Training TOLF and DM skills training sessions will be delivered by two research assistant nurses who had experience working with HF patients One therapist will be the interventionist and the second will be the monitoring coach to avoid contamination Treatment strategies will be taught through didactic instruction audio-video-recorded illustration of techniques and role-play
Procedures to Ensure Consistency of TOLF Treatment To ensure consistency with the intervention protocol 1 therapist will follow a treatment manual 2 weekly supervision will occur 3 sessions will be audio-recorded and reviewed during supervision and feedback provided and 4 ratings of treatment adherence and competence will be conducted
Data Analysis Aim 1 Analyses Feasibility will be assessed by examining accrual adherence and attrition Accrual will be indicated by meeting the recruitment goal of 80 participants in 24 months Descriptive statistics will be reported on the number of HF patients screened and determine rates of non-eligibility and refusal Adherence will be indicated by calculating the proportion successfully completing all intervention sessions within the TOLFDM arm and the proportion completing post-treatment assessments within each arm 80 completed intervention sessions and 80 completed assessments will serve as our feasibility benchmark With a sample size of 50 we will be able to estimate a rate of 80 to within the 95 confidence interval width of - 11 So if less than 69 of participants complete all intervention sessions and assessments TOLFDM will not be considered feasible Attrition will be indicated by 80 of consented participants completing the study protocol ie remain enrolled Acceptability will be indicated by 80 of patients reporting satisfaction with TOLFDM Mean7 on the CSQ Aim 2 3 Analyses Between-group effect sizes will be used to evaluate treatment effects on fluid overload symptoms TFCI body fluid level hospital readmission the number of abnormal weight fluctuations and QOL Between-group effect sizes will provide an index of relative change for TOLFDM participants vs DM participants Because small samples can differ on pretest scores effect sizes will be calculated by first creating change scores for each person The between-group effect size will then be calculated by subtracting the average DM group change score from the average TOLDDM change score and dividing this difference by the standard deviation of the pooled treatmentcontrol groups change score This study is not designed to make conclusions about efficacy without further study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None