Clinical trial NCT06065319: Wearables and Cardiac Rehabilitation
Official title: Estimating Recovery in Cardiac Rehabilitation Using Mobile Health Technology and Personalized Machine Learning
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Rehabilitation
Keywords: Cardiac Rehabilitation
Lead sponsor: Texas A&M University
Sponsor class: OTHER
Collaborators: name: Ascension Health
First posted: 2023-10-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers to cardiac rehabilitation who are capable of using smartphones for remote data collection

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Improvement in cardiac function
timeFrame: 12 weeks, 36 session cardiac rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ascension Health
state: Texas
city: College Station
country: United States
facility: Texas A&M University
state: Texas
Study officials:
affiliation: Ascension Health
name: Thomas Kurian
role: PRINCIPAL_INVESTIGATOR
References: