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| ID | Type | Description | Link |
|---|---|---|---|
| 1P30AG064201-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Targeted Health Coaching Group | Experimental |
| |
| Standard Care Group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted Health Coaching Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Physical Activity as Measured by Steps Per Day | Baseline, 3 months | |
| 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. | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 3 months |
| Change in Senior Fitness Test Score (SFT) - Arm Curls |
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Inclusion Criteria:
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)
Participation in an inpatient substance abuse rehabilitation program within one year
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| Name | Affiliation | Role |
|---|---|---|
| William E. Kraus, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Center For Living | Durham | North Carolina | 27705 | United States |
The proposed research is a Stage 0 and I pilot project that will involve a small sample (26 participants) in order to understand factors and triggers influencing physical activity participation immediately following a structured cardiac rehabilitation program and testing a targeted intervention approach to maintaining physical activity participation among older adults. Given the primary focus of this study will be intervention development and feasibility, we do not anticipate that sharing data will be of significant scientific or clinical merit. Therefore, we are not planning to share the data broadly. However, the structure of how we collect data, what data we collect, and how it will be monitored is part of the implementation and evaluation plan. Those materials will be made available.
No later than 1 year following completion of the funded project period.
The project PI and Co-investigators who use the data will be made aware of the location of the data on the Duke University secure server. All other researchers will be asked to contact the project PI to discuss the secondary use of the data or the need for direct access beyond what will be made available on clinical trials.gov. All potential users will need to oblige to make no attempt to identify participants from de-identified data.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change in Physical Activity as Measured by Steps Per Day | Posted | Mean | Standard Deviation | steps per day | Baseline, 3 months |
|
Up to 3 months
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Flutter | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine Collins-Bennett, Ph.D. | Duke University | 919-479-2368 | katherine.collins-bennett@duke.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 | Feb 23, 2024 | May 5, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2024 | Apr 4, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Standard Care Group | Behavioral | 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. |
|
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. |
| Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| 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. | Baseline, 3 months |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | Posted | Mean | Standard Deviation | percent | Baseline to 3 months |
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| 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. | One participant opted out of the post-intervention SFT due to medical issues. | Posted | Mean | Standard Deviation | chair stands/30 seconds | Baseline, 3 months |
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| 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. | One participant opted out of the post-intervention SFT due to medical issues. | Posted | Mean | Standard Deviation | arm curls/30 seconds | Baseline, 3 months |
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| 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. | One participant opted out of the post-intervention SFT due to medical issues. | Posted | Mean | Standard Deviation | meters | Baseline, 3 months |
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| 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. | One participant opted out of the post-intervention SFT due to medical issues. | Posted | Mean | Standard Deviation | steps per 2 minutes | Baseline, 3 months |
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| 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. | One participant opted out of the post-intervention SFT due to medical issues. | Posted | Mean | Standard Deviation | inches | Baseline, 3 months |
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| 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. | One participant opted out of the post-intervention SFT due to medical issues. | Posted | Mean | Standard Deviation | inches | Baseline, 3 months |
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| 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. | One participant opted out of the post-intervention SFT due to medical issues. | Posted | Mean | Standard Deviation | seconds | Baseline, 3 months |
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| 0 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | 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. | 0 | 6 | 0 | 6 | 2 | 6 |
| Atrial Fibrilation | Cardiac disorders | Non-systematic Assessment |
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| Nonsustained Ventricular Tachycardia | Cardiac disorders | Non-systematic Assessment |
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