Using a mHealth Intervention to Promote Physical Activity in Phase III Cardiac Rehabilitation Clients

Not Applicable

Recruiting

• Conditions: Cardiac Rehabilitation; Physical Activity
• Interventions: Device: mHealth 1; Device: mHealth 2

• Registration Number: NCT05795036
• Lead Sponsor: AdventHealth University

Brief Summary

In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the participants' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

1. Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.

2. Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Detailed Description

In this study, the investigators will implement a pilot project of using activity tracker (i.e., Fitbit) with phase III CR clients. The study will record the clients' daily steps and sleep patterns for 8 consecutive weeks in natural settings. Two specific aims are identified for this project:

1. Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.

2. Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Study Timeline

• Study Start: 2023-02-17
• Study First Submitted: 2023-03-21
• Study First Submitted QC: 2023-03-21
• Study First Posted: 2023-04-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-08-17
• Study Completion: 2025-12-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

• currently receiving Phase III CR at Hope Clinic
• are 18 years of age or older
• can read and communicate in English
• able to follow instructions to walk
• provided signed informed consent
• willing to wear Fitbit throughout the study
• owns a smartphone with text messaging capability (participants need to decide ahead of time if they have a phone plan that is compatible with taking additional text messages without undue financial burden for themselves)
• willing to receive text messages and phone calls from the research team.

Exclusion Criteria

• are pregnant or lactating
• have scheduled surgery or traveling within the next 8 weeks
• currently participating in other health promotion program
• sufficiently or overly active, as determined by a physical activity monitor worn for one week, indicating averaging ≥ 7,500 steps per day ("somewhat overly active").

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hope Clinic	mHealth 2	Participants will be recruited from clients admitted to the Phase III CR program at Hope Clinic. An information sheet introducing this study will be provided to clients by the assigned therapist at the Hope clinic after admission.
Hope Clinic	mHealth 1	Participants will be recruited from clients admitted to the Phase III CR program at Hope Clinic. An information sheet introducing this study will be provided to clients by the assigned therapist at the Hope clinic after admission.

Primary Outcome Measures

Name	Time	Method
Clients' demographic information will be obtained using a paper questionnaire administered at screening phase	12 months	Descriptive statistics will be used to assess completeness of study data, normality of outcome measures, and potential covariates, and to identify potential covariate imbalances between study arms

Trial Locations

Locations (1)

AdventHealth University; 🇺🇸 Orlando, Florida, United States