Cardiac RehabilitationNCT06065319
Wearables and Cardiac Rehabilitation
An observational study of Cardiac Rehabilitation, run by Texas A&M University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Wearable Sensors
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comers to cardiac rehabilitation who are capable of using smartphones for remote data collection
Who may be able to join
- Enrollment in Cardiac Rehabilitation - eligible all-comers to Cardiac Rehabilitation
- Age 18 or older
- Native English speaker
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ascension Health
Austin, Texas, 78705
Texas A&M University
College Station, Texas, 77843
About this study
Official title: Estimating Recovery in Cardiac Rehabilitation Using Mobile Health Technology and Personalized Machine Learning
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.
Read the 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.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Wearable Sensors
- Keywords
- Cardiac Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable SensorsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| All Comers to Cardiac Rehabilitation | Any participant that is enrolled in cardiac rehabilitation is eligible for this study. Receives: Device: Wearable Sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cardiac function
Improvement in the 6 minute walk test performance from pre assessment to post assessment
Measured: 12 weeks, 36 session cardiac rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Jun 2024
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Ascension Health
- Responsible party
- Sponsor
- Investigators
- Thomas Kurian, Principal investigator, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065319
- Sponsor's protocol ID
- R21EB028486
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified wearable data and 6minute walk data will be made available, upon reasonable request, for other researchers
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating Recovery in Cardiac Rehabilitation Using Mobile Health Technology and Personalized Machine Learning
- ClinicalTrials.gov ID
- NCT06065319
- Acronym / sponsor ID
- R21EB028486
- Conditions
- Cardiac Rehabilitation
- Keywords
- Cardiac Rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Ascension Health
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Comers to Cardiac Rehabilitation | – | Device: Wearable SensorsAny participant that is enrolled in cardiac rehabilitation is eligible for this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers to cardiac rehabilitation who are capable of using smartphones for remote data collection
Key inclusion criteria (3 listed)
- Enrollment in Cardiac Rehabilitation - eligible all-comers to Cardiac Rehabilitation
- Age 18 or older
- Native English speaker
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable SensorsParticipants will wear smartwatches and smartrings and this data will be used to design algorithms which seek to find associations between device data and recovery. | Device | All Comers to Cardiac Rehabilitation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: Yes. Deidentified wearable data and 6minute walk data will be made available, upon reasonable request, for other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Kurian principal investigator
Ascension Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation, run by Texas A&M University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in cardiac function (time frame: 12 weeks, 36 session cardiac rehabilitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.