Clinical trial NCT05773287: Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation
Official title: Targeted Health Coaching Intervention to Improve Physical Activity Maintenance and Mobility Post-Structured Cardiac Rehabilitation Programming Among Older Adults: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Health Coaching
Physical Activity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-03-17
Enrollment: 13
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Activity as Measured by Steps Per Day
timeFrame: Baseline, 3 months
measure: Average Adherence to Physical Activity Prescription
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change in Senior Fitness Test Score (SFT) - Chair Stands
timeFrame: Baseline, 3 months
measure: Change in Senior Fitness Test Score (SFT) - Arm Curls
timeFrame: Baseline, 3 months
measure: Change in Senior Fitness Test Score (SFT) - 6-minute Walk Test (6MWT)
timeFrame: Baseline, 3 months
measure: Change in Senior Fitness Test Score (SFT) - 2-Minute Step Test
timeFrame: Baseline, 3 months
measure: Change in Senior Fitness Test Score (SFT) - Sit & Reach
timeFrame: Baseline, 3 months
measure: Change in Senior Fitness Test Score (SFT) - Back Scratch Test
timeFrame: Baseline, 3 months
measure: Change in Senior Fitness Test Score (SFT) - Timed Up and Go Test
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Center For Living
state: North Carolina
Study officials:
affiliation: Duke University
name: William E. Kraus, MD
role: PRINCIPAL_INVESTIGATOR
References: