Cardiac RehabilitationTarget-CRNCT05773287
Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation
A study testing Targeted Health Coaching Group in people with Cardiac Rehabilitation and Health Coaching, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cardiac Rehabilitation, Health Coaching, Physical Activity
- What is being tested?
- Targeted Health Coaching Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2023to 26 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center For Living
Durham, North Carolina, 27705
About this study
Official title: Targeted Health Coaching Intervention to Improve Physical Activity Maintenance and Mobility Post-Structured Cardiac Rehabilitation Programming Among Older Adults: A Pilot Study
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.
Read the 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.
- Conditions
- Cardiac Rehabilitation, Health Coaching, Physical Activity
- Being tested
- Targeted Health Coaching Group, Standard Care Group
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted Health Coaching GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Targeted Health Coaching Group | Experimental | Not described Receives: Behavioral: Targeted Health Coaching Group |
| Standard Care Group | Placebo comparator | Not described Receives: Behavioral: Standard Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Activity as Measured by Steps Per Day
Measured: 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.
Measured: Baseline to 3 months
Secondary outcomes (7)
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.
Measured: Baseline, 3 months
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start26 Sep 2023
- Primary completion26 Jun 2024
- Study completion26 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- William E. Kraus, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773287
- Sponsor's protocol ID
- Pro00112929
- Other IDs
- 1P30AG064201-01
- Acronym
- Target-CR
- Status last verified
- Jun 2025
- First submitted
- 10 Mar 2023
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Health Coaching Intervention to Improve Physical Activity Maintenance and Mobility Post-Structured Cardiac Rehabilitation Programming Among Older Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT05773287
- Acronym / sponsor ID
- Target-CR / Pro00112929
- Conditions
- Cardiac Rehabilitation, Health Coaching, Physical Activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Sep 2023 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 26 Jun 2024 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Posted 17 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Targeted Health Coaching Group | Experimental | Behavioral: Targeted Health Coaching Group |
| Standard Care Group | Placebo comparator | Behavioral: Standard Care Group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted Health Coaching GroupParticipants 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. | Behavioural | Targeted Health Coaching Group |
| Standard Care GroupParticipants 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. | Behavioural | Standard Care Group |
Primary outcome
Change in Physical Activity as Measured by Steps Per Day
Time frame: Baseline, 3 months
Average Adherence to Physical Activity Prescription
Time frame: 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.
7 secondary outcomes
Change in Senior Fitness Test Score (SFT) - Chair Stands
Time frame: Baseline, 3 months
Change in Senior Fitness Test Score (SFT) - Arm Curls
Time frame: Baseline, 3 months
Change in Senior Fitness Test Score (SFT) - 6-minute Walk Test (6MWT)
Time frame: Baseline, 3 months
Change in Senior Fitness Test Score (SFT) - 2-Minute Step Test
Time frame: Baseline, 3 months
Change in Senior Fitness Test Score (SFT) - Sit & Reach
Time frame: Baseline, 3 months
Change in Senior Fitness Test Score (SFT) - Back Scratch Test
Time frame: Baseline, 3 months
Change in Senior Fitness Test Score (SFT) - Timed Up and Go Test
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Olive Oil Supplementation for Heart Failure With Reduced Ejection Fraction
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Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William E. Kraus, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted Health Coaching Group in people with Cardiac Rehabilitation and Health Coaching, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Physical Activity as Measured by Steps Per Day (time frame: Baseline, 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.