Trial Outcomes & Findings for HEART Camp Connect: A Feasibility Study (NCT NCT05985395)
NCT ID: NCT05985395
Last Updated: 2025-12-11
Results Overview
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.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
3 months
Results posted on
2025-12-11
Participant Flow
Participant milestones
| Measure |
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.
|
Usual Care
Participants will have access to a virtual exercise platform or membership to a medical exercise facility.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Usual Care
Participants will have access to a virtual exercise platform or membership to a medical exercise facility.
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
HEART Camp Connect: A Feasibility Study
Baseline characteristics by cohort
| Measure |
HEART Camp Connect
n=4 Participants
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.
|
Usual Care
n=3 Participants
Participants will have access to a virtual exercise platform or membership to a medical exercise facility.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.5 years
STANDARD_DEVIATION 14.01 • n=237 Participants
|
70.3 years
STANDARD_DEVIATION 6.4 • n=243 Participants
|
69.9 years
STANDARD_DEVIATION 10.6 • n=480 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=237 Participants
|
3 Participants
n=243 Participants
|
6 Participants
n=480 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=237 Participants
|
1 Participants
n=243 Participants
|
1 Participants
n=480 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=237 Participants
|
2 Participants
n=243 Participants
|
6 Participants
n=480 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=237 Participants
|
3 participants
n=243 Participants
|
7 participants
n=480 Participants
|
|
Exercise Adherence
|
0 Participants
n=237 Participants
|
0 Participants
n=243 Participants
|
0 Participants
n=480 Participants
|
|
Kansas City Cardiomyopathy Questionnaire Overall Summary Score
|
46.3 units on a scale
STANDARD_DEVIATION 16.3 • n=237 Participants
|
48.7 units on a scale
STANDARD_DEVIATION 17.1 • n=243 Participants
|
47.7 units on a scale
STANDARD_DEVIATION 15.4 • n=480 Participants
|
PRIMARY outcome
Timeframe: 3 monthsExercise 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.
Outcome measures
| Measure |
HEART Camp Connect
n=4 Participants
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.
|
Usual Care
n=3 Participants
Participants will have access to a virtual exercise platform or membership to a medical exercise facility.
|
|---|---|---|
|
Exercise Adherence
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: 1 participant in the intervention group was missing KCCQ data for 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.
Outcome measures
| Measure |
HEART Camp Connect
n=3 Participants
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.
|
Usual Care
n=3 Participants
Participants will have access to a virtual exercise platform or membership to a medical exercise facility.
|
|---|---|---|
|
Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
|
56.7 units on a scale
Standard Deviation 14.3
|
57.4 units on a scale
Standard Deviation 16.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineMeasures 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.
Outcome measures
| Measure |
HEART Camp Connect
n=4 Participants
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.
|
Usual Care
n=3 Participants
Participants will have access to a virtual exercise platform or membership to a medical exercise facility.
|
|---|---|---|
|
Smart Devices
|
2 Participants
|
1 Participants
|
Adverse Events
HEART Camp Connect
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place