Wearables and Cardiac Rehabilitation

Cardiac Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06065319
• Other study ID #: R21EB028486
• Status: Not yet recruiting
• Start date: October 1, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: Texas A&M University
• Contact: Chloe Cowan
• Phone: 51232443434
• Email: chloe.cowan[@]ascension.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 31, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
United States	Ascension Health	Austin	Texas
United States	Texas A&M University	College Station	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas A&M University	Ascension Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in cardiac function	Improvement in the 6 minute walk test performance from pre assessment to post assessment	12 weeks, 36 session cardiac rehabilitation