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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05795036
Enrollment
46
Registered
2023-04-03
Start date
2023-02-17
Completion date
2025-12-17
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Rehabilitation, Physical Activity

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.

Interventions

DEVICEmHealth 1

Participants will use Fitbit device to self-monitor their physical activity in 8 weeks.

DEVICEmHealth 2

Participants will use Fitbit device to self-monitor their physical activity in 8 weeks. In addition, they will receive daily motivational text message.

Sponsors

AdventHealth University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Masking description

Participants will be randomly assigned to either the intervention group or the control group

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Clients' demographic information will be obtained using a paper questionnaire administered at screening phase12 monthsDescriptive 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

Countries

United States

Contacts

Primary ContactChia-Wei Fan, MD
chia-wei.fan@ahu.edu407-609-1388
Backup ContactLeana Goncalves Araujo, PhD
leana.goncalvesaraujo@ahu.edu407-609-1388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026