HFpEF - Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
exercise training, patient adherence, coaching
Brief summary
The goal of this study is to learn more about patients with heart failure with preserved ejection fraction (HFpEF) and exercise. Investigators want to see if meeting with a coach in person or by video conference will help these patients exercise, feel better, and change markers in their blood. Participants will be randomly placed in one of three groups for 18 months. All groups will have access to a fitness center and be given a watch and heart rate monitor to wear during exercise. The usual care group (control group) will have access to exercise videos via the medical fitness center and will not meet with a coach. The HEART Camp group will exercise and meet with their coach in-person at the medical fitness center. The HEART Camp Connect group will have access to exercise videos via the medical fitness center and will meet with their coach via videoconferencing. All participants will take part in an exercise test and study training prior to being randomized. At four data collection time points, participants will wear an activity monitor for 7 days each, have their blood drawn, and answer questions related to heart failure and exercise. Participants will also wear a heart rate monitor when they exercise and fill out a daily exercise diary.
Detailed description
The overall objectives for this study are to: (a) test the efficacy of virtual and in-person exercise interventions to promote long-term adherence to exercise; (b) determine a benchmark of exercise minutes that reaches a minimal clinically important difference in heart failure related health status and drives improvements in physical function, inflammatory markers, and patient-reported outcomes; (c) identify interventional mechanisms, interim clinical events and prognostic indicators of heart failure with preserved ejection fraction (HFpEF) that mediate adherence; (d) assess delivery method and related cost of the intervention to support translation and scalability. To meet these objectives, investigators propose a three-group, 2-2-1 randomized repeated measures experimental design with 4 data collection points \[baseline, 6, 12, and 18 months to compare HEART Camp, HEART Camp Connect, and virtual enhanced usual care (EUC). This study begins with the cardiopulmonary exercise testing (CPET) . The CPET is used to develop an exercise prescription and ensure participant safety and readiness for exercise. Participants who have completed a CPET within 6 months of enrollment with no changes in medications will not repeat the test. Any participants who exhibit potential safety concerns during CPET (e.g. cardiac arrhythmias, balance instability) will be evaluated by a trained providers, prior to continuing in the study. Those deemed unsafe to exercise will be withdrawn. After the CPET, participants will take part in the run-in period with 3 monitored sessions in cardiac rehabilitation and study orientation. All participants will be oriented during a one-time in-person training to familiarize them with the 1) Either in-person Engage center or Engage virtual platform via the HEART Camp You Tube channel; 2) All monitoring devices (Polar watch and Polar heart rate monitor, Actigraph, rating of perceived exertion scale, and exercise diary); and 3) Private HEART Camp You Tube channel where they can view investigator-developed educational videos specific to HFpEF and virtual exercise content. Participants who do not have a smart device with internet capability or have an insufficient data plan will be given a tablet with a wireless data plan for study use. After randomization, participants in the intervention groups (HEART Camp Connect and HEART Camp) meet with a coach for the first 12 months of the study. The HEART Camp group will meet in-person at the medical fitness center with their coach. The HEART Camp Connect group will meet virtually, over videoconference. To improve the scalability of this intervention, investigators will taper coaching sessions according to the following schedule: Months 1-3 weekly, 1-on-1 coaching for 30 minutes; Months 4-12 1-on-1 coaching is reduced to 15 minute sessions every other week. On alternate weeks, participants will attend a 1-hour group-based exercise training and coaching. During these sessions, the coach will meet with 4-6 participants at once. One half of the class will be an exercise training session and the other half will be a question/answer session for participants to talk to the coach and each other about strategies for exercise. After 12 months, coaching (both intervention groups) and motivational messages (HEART Camp Connect only) will stop and participants will be expected to self-regulate exercise in months 13-18. Participants will be asked to build up to 150 minutes of moderate-intensity exercise weekly. During exercise sessions, participants will be asked to wear their study-provided watch and heart rate monitor and keep a daily exercise diary. Participants will meet with research personnel at 4 times during the study for data collection including where they will have their blood drawn and complete a 6 minute walk test. At these data collection time points, participants will also wear an activity monitor for 7 days/nights and complete surveys related to their heart failure and exercise.
Interventions
BEHAVIORALHEART Camp
Participants will meet with an in-person coach at the medical fitness center: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a 1-hour group-based exercise training and coaching).
BEHAVIORALHEART Camp Connect
Participants will meet with a virtual coach from the medical fitness center via videoconferencing: Months 1-3 weekly for 30 minutes; Months 4-12 every other week for 15 minutes (on alternate weeks, participants will attend a virtual 1-hour group-based exercise training and coaching session via videoconferencing).
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Blinded study personnel will participate in all data collection time points, meeting with participants at four time points during the study and confirming completeness of questionnaires.
Intervention model description
Participants will be randomized following a 2-2-1 (HEART Camp Connect - HEART Camp - Enhanced Usual Care) scheme to fully examine comparative effects between virtual and in-person treatment groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of heart failure with an ejection fraction greater than or equal to 50 * Echocardiogram in prior 24 months * Stable pharmacologic therapy in the past 30 days * Any of the following evidence to confirm HFpEF - Score\< 6 on Heavy Hypertensive Atrial Fibrillation, Pulmonary Hypertension, Elder, Filling Pressure algorithm, invasive hemodynamic evidence of HFpEF(i.e., elevated pulmonary wedge pressure), or a confirmed clinical diagnosis of HFpEF
Exclusion criteria
* Life-limiting illness precluding study completion * Clinical evidence of decompensated heart failure * Unstable angina or marked shortness of breath on exertion at less than 2 metabolic equivalents * Myocardial infarction, coronary artery bypass graft, or biventricular pacemaker in prior 6 weeks * Orthopedic or neuromuscular disorders preventing aerobic exercise * Cardiopulmonary exercise test results that preclude safe exercise * Unwilling/unable to complete pre-randomization procedures * Pregnancy * Implantable cardioverter defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise Adherence | 6 months | Adherence is measured as weekly minutes of moderate intensity exercise as measured by a watch and heart rate sensor. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HF-related Health Status | Baseline | Scores on the Kansas City Cardiomyopathy Questionnaire, assessing the domains of physical limitations, HF symptoms, quality of life, social impact of HF, and self efficacy. A 23-item questionnaire where scores are generated for each domain and scaled from 0-100, with 0 denoting the worst and 100 the best possible status. |
| Physical Function | Baseline | Physical function will be measured by distance in meters completed on the 6 minute walk test. |
| Physical Activity | Baseline | Physical activity will be assessed based on data gathered from participants wearing an accelerometer for 7 days/nights. |
| Dyspnea Severity | Baseline | Patient-Reported Outcomes Measurement Information System (PROMIS)-Dyspnea Severity 10a, assessing severity of shortness of breath in response to different activities over the prior 7-day period. 10 items are assessed on a 4-point Likert scale with raw scores ranging from 0-30. Higher scores indicate greater perceived dyspnea. |
| Global Symptoms | Baseline | PROMIS-29 Profile v2.1 assessing physical function, anxiety, depression, fatigue, sleep disturbances, satisfaction with social role, pain impact, and pain intensity. Pain intensity is assessed using a single 0-10 numeric rating, The 7 health domains are measured using 4 items per domain that are assessed on a 5-point Likert scale. Each domain is scored separately with raw scores ranging from 4-20, higher scores indicate worse symptomatology. |
| Health-related Quality of Life | Baseline | Euro Qual (EQ)-5 Dimension, assessing the five dimensions of mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 5 items are assessed on a 5-point Likert scale and a summary index with a maximum score of 1 is derived from the 5 dimensions by conversion with a table of scores. The maximum score of 1 indicates the best health state. |
| Health Status | Baseline | Euro Qual (EQ)-Visual Analog Scale, Participants rate their perceived health status on a scale of 0-100 with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state |
| C-reactive protein (CRP) | Baseline | CRP will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 1.33 Max 49,600 |
| C-reactive protein | 12 months | CRP will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 1.33 Max 49,600 |
| Interleukin 1-Beta (IL1-beta) | Baseline | IL1-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.05 Max 375 |
| Interleukin 1-Beta | 12 months | IL1-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.05 Max 375 |
| Interleukin 1-Alpha (IL1-alpha) | Baseline | IL1-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.09 Max 278 |
| Interleukin 1-Alpha | 12 months | IL1-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.09 Max 278 |
| Tumor Necrosis Factor-alpha (TNF-alpha) | Baseline | TNF-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.04 Max 248 |
| Tumor Necrosis Factor-alpha | 12 months | TNF-alpha will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.04 Max 248 |
| Tumor Necrosis Factor-beta | Baseline | TNF-beta will be measured from human plasma using the Mesoscale Discovery Human Biomarker Panel Unit pg/mL Min 0.08 Max 458 |
Countries
United States
Contacts
CONTACTWindy W Alonso, PhD
PRINCIPAL_INVESTIGATORWindy W Alonso, PhD
University of Virginia
PRINCIPAL_INVESTIGATORBunny Pozehl, PhD
University of Nebraska
Outcome results
None listed