Trial Outcomes & Findings for Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation (NCT NCT05773287)
NCT ID: NCT05773287
Last Updated: 2025-06-17
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
Baseline, 3 months
Results posted on
2025-06-17
Participant Flow
Participant milestones
| Measure |
Targeted Health Coaching Group
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation
Baseline characteristics by cohort
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=6 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 6.3 • n=99 Participants
|
72.5 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
70.8 years
STANDARD_DEVIATION 7.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsOutcome measures
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=6 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
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|---|---|---|
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Change in Physical Activity as Measured by Steps Per Day
|
1194 steps per day
Standard Deviation 1641
|
554 steps per day
Standard Deviation 1762
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsA metric of adherence to the steps/day prescription, calculated as (steps/day completed) divided by (steps/day prescribed) times 100 and averaged across the study period. Reported as the average adherence (percent) to the steps per day prescription across the three-month study period.
Outcome measures
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=6 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
|
|---|---|---|
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Average Adherence to Physical Activity Prescription
|
110.4 percent
Standard Deviation 26.8
|
102.7 percent
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: One participant opted out of the post-intervention SFT due to medical issues.
The chair stand test is similar to a squat test to measure leg strength, in which participants stand up repeatedly from a chair for 30 seconds. Reported as the number of completed chair stands in 30 seconds.
Outcome measures
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=5 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
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|---|---|---|
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Change in Senior Fitness Test Score (SFT) - Chair Stands
|
1.6 chair stands/30 seconds
Standard Deviation 3.1
|
2.2 chair stands/30 seconds
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: One participant opted out of the post-intervention SFT due to medical issues.
The Arm Curl test is a test of upper body strength and involves performing as many arm curls as possible in 30 seconds, while sitting in a chair. Reported as change in the number of arm curls completed in 30 seconds.
Outcome measures
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=5 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
|
|---|---|---|
|
Change in Senior Fitness Test Score (SFT) - Arm Curls
|
1.4 arm curls/30 seconds
Standard Deviation 1.5
|
2.8 arm curls/30 seconds
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: One participant opted out of the post-intervention SFT due to medical issues.
The 6MWT is reported as the distance walked in 6 minutes to the nearest meter.
Outcome measures
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=5 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
|
|---|---|---|
|
Change in Senior Fitness Test Score (SFT) - 6-minute Walk Test (6MWT)
|
5.7 meters
Standard Deviation 9.4
|
3.6 meters
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: One participant opted out of the post-intervention SFT due to medical issues.
The 2-Minute Step Test is a measure of endurance or physical stamina, reported as change in the number of steps, marching in place, achieved in 2 minutes.
Outcome measures
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=5 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
|
|---|---|---|
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Change in Senior Fitness Test Score (SFT) - 2-Minute Step Test
|
5.7 steps per 2 minutes
Standard Deviation 9.4
|
3.6 steps per 2 minutes
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: One participant opted out of the post-intervention SFT due to medical issues.
The Sit \& Reach test measures lower body flexibility, specifically hamstring flexibility. Reported as the change in distance reached in inches.
Outcome measures
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=5 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
|
|---|---|---|
|
Change in Senior Fitness Test Score (SFT) - Sit & Reach
|
0.9 inches
Standard Deviation 2.4
|
2.0 inches
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: One participant opted out of the post-intervention SFT due to medical issues.
The Back Scratch Test is a measure of upper body flexibility. This is reported as the change in distance between fingertip of the middle fingers on each hand in inches.
Outcome measures
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=5 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
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|---|---|---|
|
Change in Senior Fitness Test Score (SFT) - Back Scratch Test
|
-0.1 inches
Standard Deviation 1.0
|
0.2 inches
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: One participant opted out of the post-intervention SFT due to medical issues.
The Timed Up and Go test measures speed, agility, and balance. This is reported as the average change in time to the nearest second among two trials.
Outcome measures
| Measure |
Targeted Health Coaching Group
n=7 Participants
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=5 Participants
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
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|---|---|---|
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Change in Senior Fitness Test Score (SFT) - Timed Up and Go Test
|
0.03 seconds
Standard Deviation 0.60
|
0.20 seconds
Standard Deviation 0.60
|
Adverse Events
Targeted Health Coaching Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard Care/Education Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Targeted Health Coaching Group
n=7 participants at risk
Targeted Health Coaching Group: Participants in the THC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will partake in 6 virtual or in-person health coaching sessions lasting approximately 30-60 minutes in duration. These sessions will take place approximately every other week during the 3-month intervention period.
|
Standard Care/Education Group
n=6 participants at risk
Standard Care Group: Participants in the SC group will receive an exercise prescription (steps/day) based on their last cardiac rehabilitation session exercise prescription. Participants will be provided a Garmin wearable device to track steps/day. Additionally, participants will be provided with a single virtual or in-person education session, lasting approximately 30 minutes, at the beginning of the 3-month intervention period.
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|---|---|---|
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Cardiac disorders
Atrial Flutter
|
0.00%
0/7 • Up to 3 months
|
16.7%
1/6 • Up to 3 months
|
|
Cardiac disorders
Atrial Fibrilation
|
14.3%
1/7 • Number of events 1 • Up to 3 months
|
0.00%
0/6 • Up to 3 months
|
|
Cardiac disorders
Nonsustained Ventricular Tachycardia
|
0.00%
0/7 • Up to 3 months
|
16.7%
1/6 • Number of events 1 • Up to 3 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place