Wearables and Cardiac Rehabilitation

Sponsor
Texas A&M University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06065319
Collaborator
Ascension Health (Industry)
50
2
8
25
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Wearable Sensors

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Estimating Recovery in Cardiac Rehabilitation Using Mobile Health Technology and Personalized Machine Learning
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Mar 1, 2024
Anticipated Study Completion Date :
May 31, 2024

Arms and Interventions

Arm Intervention/Treatment
All Comers to Cardiac Rehabilitation

Any participant that is enrolled in cardiac rehabilitation is eligible for this study.

Device: Wearable Sensors
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.

Outcome Measures

Primary Outcome Measures

  1. Improvement in cardiac function [12 weeks, 36 session cardiac rehabilitation]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ascension Health Austin Texas United States 78705
2 Texas A&M University College Station Texas United States 77843

Sponsors and Collaborators

  • Texas A&M University
  • Ascension Health

Investigators

  • Principal Investigator: Thomas Kurian, Ascension Health

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Texas A&M University
ClinicalTrials.gov Identifier:
NCT06065319
Other Study ID Numbers:
  • R21EB028486
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Texas A&M University

Study Results

No Results Posted as of Oct 3, 2023