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

NCT05773287 | Completed Results

• 2 other identifiers: Pro001129291P30AG064201-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Rehabilitation; Health Coaching; Physical Activity

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Change in Senior Fitness Test Score (SFT) - Chair Stands

  Baseline, 3 months

• Change in Senior Fitness Test Score (SFT) - Arm Curls

  Baseline, 3 months

• Change in Senior Fitness Test Score (SFT) - 6-minute Walk Test (6MWT)

  Baseline, 3 months

• Change in Senior Fitness Test Score (SFT) - 2-Minute Step Test

  Baseline, 3 months

• Change in Senior Fitness Test Score (SFT) - Sit & Reach

  Baseline, 3 months

Study Arms (2)

Targeted Health Coaching Group

EXPERIMENTAL

Behavioral: Targeted Health Coaching Group

Standard Care Group

PLACEBO COMPARATOR

Behavioral: Standard Care Group

Interventions

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.

Targeted Health Coaching Group

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.

Standard Care Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Duke Center For Living

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Katherine Collins-Bennett, Ph.D.
• Organization: Duke University

katherine.collins-bennett@duke.edu

919-479-2368

Study Officials

• William E. Kraus, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 17, 2023
• Study Start: September 26, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: June 17, 2025
• Results First Posted: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: No later than 1 year following completion of the funded project period.
• Access Criteria: 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.

Locations

US (1)