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R01 grant received, had to terminate preliminary research
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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.
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(females with maximum oxygen consumption ≥ 21ml/kg/min and males with oxygen consumption ≥ 24 ml/kg/min) will be withdrawn from the study.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEART Camp Connect | Experimental | 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. |
|
| Usual Care | No Intervention | Participants will have access to a virtual exercise platform or membership to a medical exercise facility. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEART Camp Connect | Behavioral | Once eligible and enrolled, participants will complete 150 minutes of moderate-intensity exercise a week with help of a virtual exercise coach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Windy W Alonso, PhD, RN | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-5330 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Participants will have access to a virtual exercise platform or membership to a medical exercise facility. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 3 months |
|
Events data collected for 3 months
We used standard definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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We initially planned to enroll 25 participants per arm but upon receipt of R01 funding the funds for this pilot study had to be forfeited. Therefore, only 7 were enrolled and completed. Data collection and analyses were limited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Windy Alonso | University of Nebraska Medical Center | 814-577-2941 | windy.alonso@unmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 26, 2023 | Feb 28, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2024 | Nov 14, 2025 | ICF_001.pdf |
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| 3 months |
| BG001 | Usual Care | Participants will have access to a virtual exercise platform or membership to a medical exercise facility. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | As reported in medical record | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Exercise Adherence | At baseline all participants were sedentary and not participating in exercise | Count of Participants | Participants |
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| Kansas City Cardiomyopathy Questionnaire Overall Summary Score | Mean | Standard Deviation | units on a scale |
|
|
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| 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. | 1 participant in the intervention group was missing KCCQ data for 3 months | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| 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. | Posted | Count of Participants | Participants | Baseline |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Usual Care | Participants will have access to a virtual exercise platform or membership to a medical exercise facility. | 0 | 3 | 0 | 3 | 0 | 3 |
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