Heart Failure With Preserved Ejection Fraction
Conditions
Keywords
exercise training, adherence, coaching
Brief summary
This study builds on the tested and refined HEART Camp intervention which has been shown to improve long-term adherence to exercise in individuals diagnosed with heart failure. HEART Camp Connect enhances HEART Camp by delivering the coaching via videoconference and providing access to hospital-based exercise facilities and online exercise programming. This prospective study uses a 2-group, randomized repeated measures experimental design with 3 data collection points baseline, Month 3, and Month 6.
Detailed description
Potential participants will be approached at a Heart Failure clinic at an academic medical center. As a secondary recruitment strategy, we will use a database that identifies patients who previously indicated their willingness to be contacted for clinical research. Study personnel will obtain informed consent in person in a private room or over the phone facilitated by the academic medical center electronic consent process. Once consented, participants will complete cardiopulmonary exercise testing (CPET) to guide individual exercise prescriptions and protect against risks associated with exercise. CPET results that preclude safe exercise training (arrhythmia) or those with CPET results indicating cardio-respiratory fitness (females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study. Participants will be given instruction on the use of the heart rate monitor. Participants will wear their monitor exercise sessions for heart rate monitoring. Participants will also receive educational training via videos on topics such as exercising with heart failure, how medications impact exercise, and nutrition. Participants will be instructed to wear a heart rate monitor and strive to meet a goal of 150 minutes of moderate-intensity exercise per week. Minutes toward adherence goals for the study will be calculated as time spent participating in a moderate-intensity activity and determined by their CPET results and personalized exercise prescription. Each participant will be given access to an Omaha-based exercise coach that he/she will meet with weekly over Zoom for 30 minutes. Coaches will discuss exercise over the past week including problems, issues, concerns. Goals will be set, reviewed, assessed, and revised each week. For virtual exercise, all participants will access a Virtual Wellness Center.
Interventions
BEHAVIORALHEART Camp Connect
Once eligible and enrolled, participants will complete 150 minutes of moderate-intensity exercise a week with help of a virtual exercise coach.
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of heart failure (HF) with an ejection fraction (EF) ≥50% * Age ≥18 years * English-speaking * Echocardiogram in prior 12 months * Stable pharmacologic therapy in past 30 days
Exclusion criteria
* Score\<6 on a diagnostic algorithm * Life-limiting illness precluding study completion * Clinical evidence of decompensated HF * Unstable angina or marked shortness of breath on exertion at \<2 metabolic equivalents * Myocardial infarction, coronary artery bypass surgery, or biventricular pacemaker \<6 weeks * Orthopedic or neuromuscular disorders preventing participation in 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 | 3 months | Exercise adherence is defined as a count of the number of participants meeting 120 minutes or more of moderate intensity exercise per week at the prespecified time point of 3 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 3 months | KCCQ measures heart failure related health status. The overall summary score ranges from 0 to 100, with higher scores indicating better health status, typically interpreted in 25-point ranges as: very poor to poor (0-24), poor to fair (25-49), fair to good (50-74), and good to excellent (75-100). A change in score of 5 points or more is considered clinically meaningful. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Smart Devices | Baseline | Measures is a count of the number of potential participants without smart devices at baseline. Participants without a smart device are loaned one for the duration of the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HEART Camp Connect Participants will have access to a virtual exercise platform or membership to a medical exercise facility. Participants will meet with a virtual exercise coach via Zoom on a weekly basis.
HEART Camp Connect: Once eligible and enrolled, participants will complete 150 minutes of moderate-intensity exercise a week with help of a virtual exercise coach. | 4 |
| Usual Care Participants will have access to a virtual exercise platform or membership to a medical exercise facility. | 3 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Care | Total | HEART Camp Connect |
|---|---|---|---|
| Age, Continuous | 70.3 years STANDARD_DEVIATION 6.4 | 69.9 years STANDARD_DEVIATION 10.6 | 69.5 years STANDARD_DEVIATION 14.01 |
| Exercise Adherence | 0 Participants | 0 Participants | 0 Participants |
| Kansas City Cardiomyopathy Questionnaire Overall Summary Score | 48.7 units on a scale STANDARD_DEVIATION 17.1 | 47.7 units on a scale STANDARD_DEVIATION 15.4 | 46.3 units on a scale STANDARD_DEVIATION 16.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 6 Participants | 4 Participants |
| Region of Enrollment United States | 3 participants | 7 participants | 4 participants |
| Sex: Female, Male Female | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
Exercise Adherence
Exercise adherence is defined as a count of the number of participants meeting 120 minutes or more of moderate intensity exercise per week at the prespecified time point of 3 months.
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEART Camp Connect | Exercise Adherence | 1 Participants |
| Usual Care | Exercise Adherence | 1 Participants |
Secondary
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
KCCQ measures heart failure related health status. The overall summary score ranges from 0 to 100, with higher scores indicating better health status, typically interpreted in 25-point ranges as: very poor to poor (0-24), poor to fair (25-49), fair to good (50-74), and good to excellent (75-100). A change in score of 5 points or more is considered clinically meaningful.
Time frame: 3 months
Population: 1 participant in the intervention group was missing KCCQ data for 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HEART Camp Connect | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 56.7 units on a scale | Standard Deviation 14.3 |
| Usual Care | Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score | 57.4 units on a scale | Standard Deviation 16.1 |
Other Pre-specified
Smart Devices
Measures is a count of the number of potential participants without smart devices at baseline. Participants without a smart device are loaned one for the duration of the study.
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEART Camp Connect | Smart Devices | 2 Participants |
| Usual Care | Smart Devices | 1 Participants |