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

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05795036
• Other study ID #: 1848850-2
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: December 17, 2024

Study information

• Verified date: March 2023
• Source: AdventHealth University
• Contact: Chia-Wei Fan, MD
• Phone: 407-609-1388
• Email: chia-wei.fan[@]ahu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we 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.

Description:

In this study, we 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 17, 2024
• Est. primary completion date: February 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Clients who met the following criteria will be recruited using convenience sampling: (i) currently receiving Phase III CR at Hope Clinic (ii) are 18 years of age or older (iii) can read and communicate in English (iv) able to follow instructions to walk (v) provided signed informed consent (vi) willing to wear Fitbit throughout the study (vii) 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) (viii) willing to receive text messages and phone calls from the research team.

Exclusion Criteria:

• Clients will be excluded if they: (i) are pregnant or lactating (ii) have scheduled surgery or traveling within the next 8 weeks (iii) currently participating in other health promotion program (iv) 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").

Related Conditions & MeSH terms

• Cardiac Rehabilitation
• Physical Activity

Intervention

Device:
• Mhealth
Using a mHealth intervention to promote physical activity in Phase III cardiac rehabilitation clients

Locations

Country	Name	City	State
United States	AdventHealth University	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clients' demographic information will be obtained using a paper questionnaire administered at screening phase	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	12 months