Targeted Health Coaching to Improve Physical Activity Post-Structured Cardiac Rehabilitation

NCT ID: NCT05773287

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2024-06-26

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.

Conditions

Cardiac Rehabilitation; Health Coaching; Physical Activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Targeted Health Coaching Group

Group Type: EXPERIMENTAL

Targeted Health Coaching Group

Intervention Type: 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.

Standard Care Group

Group Type: PLACEBO_COMPARATOR

Standard Care Group

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William E. Kraus, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Center For Living

Durham, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1P30AG064201-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00112929

Identifier Type: -

Identifier Source: org_study_id