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OpenTrials
Active, Not Recruiting

NCT Number: NCT06065319

Wearables and Cardiac Rehabilitation

The goal of this study is to collect wearable sensor data that the investigators hypothesize will be useful in future algorithm development for monitoring recovering of participants enrolled in cardiac rehabilitation programs. Participants will be provided one or more smartwatches and/or smart rings to wear during a 14 week study which includes 2 weeks of baseline data collection and a 12-week, 36-session cardiac rehabilitation program. They will capture a pre-assessment 6 minute walk tests and a post-assessment 6 minute walk test. They will otherwise conduct standard cardiac rehabilitation program procedures and our sensors will capture data and sleep information throughout the study period.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ascension Health, Austin, Texas, United States

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About this study

The goal of this study is to collect wearable sensor data that the investigators hypothesize will be useful in future algorithm development for monitoring the recovery of participants enrolled in cardiac rehabilitation programs. Participants will be provided one or more smartwatches and/or smart rings to wear during a 14 week study which includes 2 weeks of baseline data collection and a 12-week, 36-session cardiac rehabilitation program. They will capture a pre-assessment 6 minute walk tests and a post-assessment 6 minute walk test. They will otherwise conduct standard cardiac rehabilitation program procedures and our sensors will capture data and sleep information throughout the study period.

This work will use data from cardiac rehabilitation, captured from smartwatches, and data from rest/sleep, captured from smartwatches and smartrings, to see if there are trends in recovery that can be modeled. Recovery is measured as an improvement in 6 minute walk test performance over the course of cardiac rehabilitation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Enrollment in Cardiac Rehabilitation - eligible all-comers to Cardiac Rehabilitation
  • Age 18 or older
  • Native English speaker

Exclusion criteria

  • Inability to wear one or more SmartWatches or Smartring
  • Inability to walk unassisted
  • Inability to participate in cardiac rehabilitation
  • Inability to use a smartphone to aid in upload of remote data
  • Lack of smartphone to use in the study
  • There is a change in participant health such that the participant meets any of the exclusion criteria for this study during the course of the cardiac rehab sessions

Treatment and study plan

Wearable sensors

Device

Participants will wear smartwatches and smartrings and this data will be used to design algorithms which seek to find associations between device data and recovery.

Primary outcomes

  1. Improvement in cardiac function

    Time frame: 12 weeks, 36 session cardiac rehabilitation

    Improvement in the 6 minute walk test performance from pre assessment to post assessment

Sponsors and collaborators

Lead sponsor

Texas A&M University

Other

Collaborators

  • Ascension Health

Registry information

Official study title

Estimating Recovery in Cardiac Rehabilitation Using Mobile Health Technology and Personalized Machine Learning

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2023
Registry last updated
Sep 23, 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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