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NCT Number: NCT05795036

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

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.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AdventHealth University

Orlando, Florida, 32803, United States

Location status: Recruiting

Location contact

Leana Goncalves Araujo

CONTACT

About this study

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:

  • Develop an intervention protocol using mHealth to promote Phase III CR clients' self-monitoring of PA.
  • Examine the efficacy of the intervention on clients' PA, sleep patterns, functional capacity and QoL.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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").

Treatment and study plan

mHealth 1

Device

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

mHealth 2

Device

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

Primary outcomes

  1. Clients' demographic information will be obtained using a paper questionnaire administered at screening phase

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Wei Fan, MD

CONTACT

[email protected]

407-609-1388

Leana Goncalves Araujo, PhD

CONTACT

[email protected]

407-609-1388

Sponsors and collaborators

Lead sponsor

AdventHealth University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 3, 2023
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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