Clinical trial NCT05784753: HEART Camp Connect -Promoting Exercise in Adults With Heart Failure With Preserved Ejection Fraction
Official title: HEART (Heart Failure Exercise and Resistance Training) Camp Connect: Promoting Adherence to Exercise in Adults With Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HFpEF - Heart Failure With Preserved Ejection Fraction
Keywords: exercise training
patient adherence
coaching
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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
* Score greater than or equal to 6 on the heart failure with preserved ejection fraction algorithm or hemodynamic evidence 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

Primary outcomes:
measure: Exercise Adherence
timeFrame: 6 months
measure: Exercise Adherence
timeFrame: 12 months
measure: Exercise Adherence
timeFrame: 18 months
Secondary outcomes:
measure: HF-related Health Status
timeFrame: Baseline
measure: HF-related Health Status
timeFrame: 6 months
measure: HF-related Health Status
timeFrame: 12 months
measure: HF-related Health Status
timeFrame: 18 months
measure: Physical Function
timeFrame: Baseline
measure: Physical Function
timeFrame: 6 months
measure: Physical Function
timeFrame: 12 months
measure: Physical Function
timeFrame: 18 months
measure: Physical Activity
timeFrame: Baseline
measure: Physical Activity
timeFrame: 6 months
measure: Physical Activity
timeFrame: 12 months
measure: Physical Activity
timeFrame: 18 months
measure: Dyspnea Severity
timeFrame: Baseline
measure: Dyspnea Severity
timeFrame: 6 months
measure: Dyspnea Severity
timeFrame: 12 months
measure: Dyspnea Severity
timeFrame: 18 months
measure: Global Symptoms
timeFrame: Baseline
measure: Global Symptoms
timeFrame: 6 months
measure: Global Symptoms
timeFrame: 12 months
measure: Global Symptoms
timeFrame: 18 months
measure: Health-related Quality of Life
timeFrame: Baseline
measure: Health-related Quality of Life
timeFrame: 6 months
measure: Health-related Quality of Life
timeFrame: 12 months
measure: Health-related Quality of Life
timeFrame: 18 months
measure: Health Status
timeFrame: Baseline
measure: Health Status
timeFrame: 6 months
measure: Health Status
timeFrame: 12 months
measure: Health Status
timeFrame: 18 months
measure: C-reactive protein (CRP)
timeFrame: Baseline
measure: C-reactive protein
timeFrame: 12 months
measure: Interleukin 1-Beta (IL1-beta)
timeFrame: Baseline
measure: Interleukin 1-Beta
timeFrame: 12 months
measure: Interleukin 1-Alpha (IL1-alpha)
timeFrame: Baseline
measure: Interleukin 1-Alpha
timeFrame: 12 months
measure: Tumor Necrosis Factor-alpha (TNF-alpha)
timeFrame: Baseline
measure: Tumor Necrosis Factor-alpha
timeFrame: 12 months
measure: Tumor Necrosis Factor-beta
timeFrame: Baseline
measure: Tumor Necrosis Factor-beta
timeFrame: 12 months
Other outcomes:
measure: Self-Efficacy
timeFrame: Baseline
measure: Self-Efficacy
timeFrame: 6 months
measure: Self-Efficacy
timeFrame: 12 months
measure: Self-Efficacy
timeFrame: 18 months
measure: Outcome Expectations
timeFrame: Baseline
measure: Outcome Expectations
timeFrame: 6 months
measure: Outcome Expectations
timeFrame: 12 months
measure: Outcome Expectations
timeFrame: 18 months
measure: Attitudes toward exercise
timeFrame: Baseline
measure: Attitudes toward exercise
timeFrame: 6 months
measure: Attitudes toward exercise
timeFrame: 12 months
measure: Attitudes toward exercise
timeFrame: 18 months
measure: Self-Regulation
timeFrame: Baseline
measure: Self-Regulation
timeFrame: 6 months
measure: Self-Regulation
timeFrame: 12 months
measure: Self-Regulation
timeFrame: 18 months
measure: Informational Support
timeFrame: Baseline
measure: Informational Support
timeFrame: 6 months
measure: Informational Support
timeFrame: 12 months
measure: Informational Support
timeFrame: 18 months
measure: Instrumental Support
timeFrame: Baseline
measure: Instrumental Support
timeFrame: 6 months
measure: Instrumental Support
timeFrame: 12 months
measure: Instrumental Support
timeFrame: 18 months
measure: Social Isolation
timeFrame: Baseline
measure: Social Isolation
timeFrame: 6 months
measure: Social Isolation
timeFrame: 12 months
measure: Social Isolation
timeFrame: 18 months
measure: Emotional Support
timeFrame: Baseline
measure: Emotional Support
timeFrame: 6 months
measure: Emotional Support
timeFrame: 12 months
measure: Emotional Support
timeFrame: 18 months
measure: Types of Physical Activity
timeFrame: Baseline
measure: Types of Physical Activity
timeFrame: 6 months
measure: Types of Physical Activity
timeFrame: 12 months
measure: Types of Physical Activity
timeFrame: 18 months
measure: Fatigue
timeFrame: Baseline
measure: Fatigue
timeFrame: 6 months
measure: Fatigue
timeFrame: 12 months
measure: Fatigue
timeFrame: 18 months
measure: Cognitive Assessment
timeFrame: Baseline
measure: Cognitive Assessment
timeFrame: 6 months
measure: Cognitive Assessment
timeFrame: 12 months
measure: Cognitive Assessment
timeFrame: 18 months
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Windy W Alonso, PhD
role: PRINCIPAL_INVESTIGATOR
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