Cardiac Rehabilitation, Health Coaching, Physical Activity
Conditions
Brief summary
To identify factors and triggers influencing physical activity (PA) participation after structured cardiac rehabilitation (CR) among older adults who have enrolled in a center-based CR program, and compare the effects of a targeted health coaching intervention versus standard care immediately following structured CR on PA maintenance and functional fitness.
Detailed description
Approximately 800,000 individuals in the United States have a heart attack every year, with almost 1 in 4 of those individuals already having suffered a previous heart attack. Attending cardiac rehabilitation (CR) following a cardiovascular event improves cardiorespiratory fitness and health-related quality of life, as well as decreases the risk of future illness and death from heart disease. Unfortunately, once an individual finishes a CR program, continued participation in physical activity (PA) too often reverts to previous sedentary patterns, limiting beneficial health effects. Continued participation in PA post-CR is especially challenging among older adults - likely due to a lack of self-efficacy and confidence in their ability to perform PA due to either their age or other health conditions that make PA more challenging. However, the need to address other health conditions, in conjunction with the benefits of improved strength and mobility, makes continued PA participation following a structured CR program even more useful for older adults. Although individuals typically understand habitual participation in PA is good for their health, we poorly understand why some individuals successfully adhere to and maintain PA habits, while others succumb to barriers preventing them from maintaining the health benefits beyond CR. In addition to understanding factors and triggers influencing PA maintenance beyond CR, little research has developed or investigated interventions targeting this important transition period following structured CR programming to promote continued PA participation at home. Therefore, this proposal aims to 1) identify factors and triggers influencing PA participation after a traditional 36-session CR program (Stage 0); and 2) test a targeted health coaching intervention using these identified triggers to optimize PA maintenance and mobility among older adults who completed a center-based CR program.
Interventions
BEHAVIORALTargeted 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.
BEHAVIORALStandard 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.
Sponsors
National Institute on Aging (NIA)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willingness to provide informed consent to participate in the Target-CR Study * Must be able to read and speak English well enough to provide informed consent and understand instructions * Age ≥60 years * Diagnosed with coronary heart disease * Of adequate clinical stability to allow study participation * Own a smartphone device for application download
Exclusion criteria
* Planned relocation during the 3-month study period * Medical procedure scheduled within the 3-month study period that may limit physical activity (i.e., joint replacement) * Decompensated heart failure * Heart failure - New York Heart Association class IV * Severe pulmonary hypertension * End-stage renal disease * Cardiac transplantation * Impairment from stroke, injury, or other medical condition that would prevent participation in the intervention * Dementia that would prevent participation in the intervention and following study protocols * Any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol * Psychiatric illness (self-report and screening) * Hospitalization for any psychiatric condition within one year (self-report) * Integrative Health Coaching Mental Health Screening Questionnaire score \>4 (screening) * Participation in an inpatient substance abuse rehabilitation program within one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Activity as Measured by Steps Per Day | Baseline, 3 months | — |
| Average Adherence to Physical Activity Prescription | Baseline to 3 months | A 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Senior Fitness Test Score (SFT) - 6-minute Walk Test (6MWT) | Baseline, 3 months | The 6MWT is reported as the distance walked in 6 minutes to the nearest meter. |
| Change in Senior Fitness Test Score (SFT) - 2-Minute Step Test | Baseline, 3 months | 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. |
| Change in Senior Fitness Test Score (SFT) - Chair Stands | Baseline, 3 months | 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. |
| Change in Senior Fitness Test Score (SFT) - Back Scratch Test | Baseline, 3 months | 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. |
| Change in Senior Fitness Test Score (SFT) - Timed Up and Go Test | Baseline, 3 months | 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. |
| Change in Senior Fitness Test Score (SFT) - Sit & Reach | Baseline, 3 months | The Sit & Reach test measures lower body flexibility, specifically hamstring flexibility. Reported as the change in distance reached in inches. |
| Change in Senior Fitness Test Score (SFT) - Arm Curls | Baseline, 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 7 |
| 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. | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Targeted Health Coaching Group | Total | Standard Care/Education Group |
|---|---|---|---|
| Age, Continuous | 69.4 years STANDARD_DEVIATION 6.3 | 70.8 years STANDARD_DEVIATION 7 | 72.5 years STANDARD_DEVIATION 8 |
| 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 | 2 Participants | 1 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 | 6 Participants | 11 Participants | 5 Participants |
| Region of Enrollment United States | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Female | 4 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 1 / 7 | 2 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
Average Adherence to Physical Activity Prescription
A 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.
Time frame: Baseline to 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Health Coaching Group | Average Adherence to Physical Activity Prescription | 110.4 percent | Standard Deviation 26.8 |
| Standard Care/Education Group | Average Adherence to Physical Activity Prescription | 102.7 percent | Standard Deviation 18.1 |
p-value: 0.552t-test, 2 sided
Primary
Change in Physical Activity as Measured by Steps Per Day
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Health Coaching Group | Change in Physical Activity as Measured by Steps Per Day | 1194 steps per day | Standard Deviation 1641 |
| Standard Care/Education Group | Change in Physical Activity as Measured by Steps Per Day | 554 steps per day | Standard Deviation 1762 |
p-value: 0.509t-test, 2 sided
Secondary
Change in Senior Fitness Test Score (SFT) - 2-Minute Step Test
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.
Time frame: Baseline, 3 months
Population: One participant opted out of the post-intervention SFT due to medical issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Health Coaching Group | Change in Senior Fitness Test Score (SFT) - 2-Minute Step Test | 5.7 steps per 2 minutes | Standard Deviation 9.4 |
| Standard Care/Education Group | Change in Senior Fitness Test Score (SFT) - 2-Minute Step Test | 3.6 steps per 2 minutes | Standard Deviation 3.1 |
Secondary
Change in Senior Fitness Test Score (SFT) - 6-minute Walk Test (6MWT)
The 6MWT is reported as the distance walked in 6 minutes to the nearest meter.
Time frame: Baseline, 3 months
Population: One participant opted out of the post-intervention SFT due to medical issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Health Coaching Group | Change in Senior Fitness Test Score (SFT) - 6-minute Walk Test (6MWT) | 5.7 meters | Standard Deviation 9.4 |
| Standard Care/Education Group | Change in Senior Fitness Test Score (SFT) - 6-minute Walk Test (6MWT) | 3.6 meters | Standard Deviation 3.1 |
Secondary
Change in Senior Fitness Test Score (SFT) - Arm Curls
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.
Time frame: Baseline, 3 months
Population: One participant opted out of the post-intervention SFT due to medical issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Health Coaching Group | Change in Senior Fitness Test Score (SFT) - Arm Curls | 1.4 arm curls/30 seconds | Standard Deviation 1.5 |
| Standard Care/Education Group | Change in Senior Fitness Test Score (SFT) - Arm Curls | 2.8 arm curls/30 seconds | Standard Deviation 2.5 |
Secondary
Change in Senior Fitness Test Score (SFT) - Back Scratch Test
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.
Time frame: Baseline, 3 months
Population: One participant opted out of the post-intervention SFT due to medical issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Health Coaching Group | Change in Senior Fitness Test Score (SFT) - Back Scratch Test | -0.1 inches | Standard Deviation 1 |
| Standard Care/Education Group | Change in Senior Fitness Test Score (SFT) - Back Scratch Test | 0.2 inches | Standard Deviation 1.3 |
Secondary
Change in Senior Fitness Test Score (SFT) - Chair Stands
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.
Time frame: Baseline, 3 months
Population: One participant opted out of the post-intervention SFT due to medical issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Health Coaching Group | Change in Senior Fitness Test Score (SFT) - Chair Stands | 1.6 chair stands/30 seconds | Standard Deviation 3.1 |
| Standard Care/Education Group | Change in Senior Fitness Test Score (SFT) - Chair Stands | 2.2 chair stands/30 seconds | Standard Deviation 1.1 |
Secondary
Change in Senior Fitness Test Score (SFT) - Sit & Reach
The Sit & Reach test measures lower body flexibility, specifically hamstring flexibility. Reported as the change in distance reached in inches.
Time frame: Baseline, 3 months
Population: One participant opted out of the post-intervention SFT due to medical issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Health Coaching Group | Change in Senior Fitness Test Score (SFT) - Sit & Reach | 0.9 inches | Standard Deviation 2.4 |
| Standard Care/Education Group | Change in Senior Fitness Test Score (SFT) - Sit & Reach | 2.0 inches | Standard Deviation 7.3 |
Secondary
Change in Senior Fitness Test Score (SFT) - Timed Up and Go Test
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.
Time frame: Baseline, 3 months
Population: One participant opted out of the post-intervention SFT due to medical issues.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Targeted Health Coaching Group | Change in Senior Fitness Test Score (SFT) - Timed Up and Go Test | 0.03 seconds | Standard Deviation 0.6 |
| Standard Care/Education Group | Change in Senior Fitness Test Score (SFT) - Timed Up and Go Test | 0.20 seconds | Standard Deviation 0.6 |