Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06644014
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Reducing Arterial Stiffness with a Smart Ring and AI-Guided Exercise
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Guidance with Oura and AI for Reducing Arterial Stiffness - the GONDOR-AS Trial
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GONDOR-AS
Brief Summary:
The goal of this three-month clinical trial is to study if wearing an Oura Ring and following the exercise guidance provided by an AI-based Advisor in the Oura App works to reduce arterial stiffness It will also study the difference between different exercise protocols in reducing arterial stiffness and improving aerobic fitness The main questions the study aims to answer are
Can an AI-based Advisor provide useful exercise guidance that helps improve cardiovascular health and aerobic fitness
Does regular exercise lower arterial stiffness measured with a clinical reference device and Oura Rings proprietary Cardiovascular Age -metric and its estimated arterial stiffness
Is there a difference between attending supervised high-intensity interval HIIT training sessions and following personalized exercise instructions for steady-state aerobic training
Participants will
Follow Ouras AI Advisors instructions at their own convenience attend supervised training sessions or just wear the Ring without changing their lifestyle
Visit an exercise physiology lab in the beginning of the trial and after three months for measurements in arterial stiffness cardiorespiratory fitness and body composition
In addition the study contains questionnaires investigating the participants experiences related to lifestyle changes
Can an AI-based Advisor provide useful exercise guidance that helps improve cardiovascular health and aerobic fitness
Does regular exercise lower arterial stiffness measured with a clinical reference device and Oura Rings proprietary Cardiovascular Age -metric and its estimated arterial stiffness
Is there a difference between attending supervised high-intensity interval HIIT training sessions and following personalized exercise instructions for steady-state aerobic training
Participants will
Follow Ouras AI Advisors instructions at their own convenience attend supervised training sessions or just wear the Ring without changing their lifestyle
Visit an exercise physiology lab in the beginning of the trial and after three months for measurements in arterial stiffness cardiorespiratory fitness and body composition
In addition the study contains questionnaires investigating the participants experiences related to lifestyle changes
Detailed Description:
This is a single-site 12-week randomized controlled trial RCT consisting of three groups N 55 per group
The Oura Ring a control group
The Oura Ring Supervised high-intensity interval training HIIT twice a week
The Oura Ring AI-based Coaching for steady-state aerobic training no external supervision
Exercise modalities are selected based on hypothesized long-term sustainability and expected cardiorespiratory outcomes The HIIT protocol has been tested in previous studies and found to be effective in improving VO2max but it is unlikely to be sustainable in the long-term Thus in this study we compare the HIIT protocol to individualized steady-state Zone 2 exercise guidance provided by AI
Participants will be recruited via e-mail and newspaper ads from the region of Kuopio Finland All groups will be blinded to their CVAPWV information but will use identical Rings Apart from the AI coach -group Oura Ring App experiences will also be identical The study consists of four 4 visits
The study site is Kuopio Institute for Exercise Medicine Kuopio Finland Participants will be provided materials for an informed consent prior to participation Eligible participants who have provided a written consent will be invited for the first baseline measurement Visit 1 where they will be provided Oura Rings and given instructions for using it and their VO2max is measured The next baseline measurement Visit 2 is scheduled for two weeks which is the time the Ring needs to calibrate its Cardiovascular Age and pulse-wave velocity PWV estimates At the second baseline measurement the participants PWV is recorded with a reference device and their body composition is also measured Following these measurements they are immediately randomized to one of the three study groups and given written and oral instructions specific to their allocation After 12 weeks the participant is invited for a repeated VO2max measurement Visit 3 followed by final PWV and body composition measurements Visit 4 within the same week Measurements are not conducted on the same days due to fasting requirements for PWV and interfering effect of VO2max testing on PWV
The Oura Ring a control group
The Oura Ring Supervised high-intensity interval training HIIT twice a week
The Oura Ring AI-based Coaching for steady-state aerobic training no external supervision
Exercise modalities are selected based on hypothesized long-term sustainability and expected cardiorespiratory outcomes The HIIT protocol has been tested in previous studies and found to be effective in improving VO2max but it is unlikely to be sustainable in the long-term Thus in this study we compare the HIIT protocol to individualized steady-state Zone 2 exercise guidance provided by AI
Participants will be recruited via e-mail and newspaper ads from the region of Kuopio Finland All groups will be blinded to their CVAPWV information but will use identical Rings Apart from the AI coach -group Oura Ring App experiences will also be identical The study consists of four 4 visits
The study site is Kuopio Institute for Exercise Medicine Kuopio Finland Participants will be provided materials for an informed consent prior to participation Eligible participants who have provided a written consent will be invited for the first baseline measurement Visit 1 where they will be provided Oura Rings and given instructions for using it and their VO2max is measured The next baseline measurement Visit 2 is scheduled for two weeks which is the time the Ring needs to calibrate its Cardiovascular Age and pulse-wave velocity PWV estimates At the second baseline measurement the participants PWV is recorded with a reference device and their body composition is also measured Following these measurements they are immediately randomized to one of the three study groups and given written and oral instructions specific to their allocation After 12 weeks the participant is invited for a repeated VO2max measurement Visit 3 followed by final PWV and body composition measurements Visit 4 within the same week Measurements are not conducted on the same days due to fasting requirements for PWV and interfering effect of VO2max testing on PWV
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None