Reducing Arterial Stiffness with a Smart Ring and AI-Guided Exercise
NCT ID: NCT06644014
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
165 participants
INTERVENTIONAL
2024-09-16
2025-07-31
Brief Summary
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* 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 Ring's 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 Oura's AI Advisor's 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
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* 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 CVA/PWV 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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AI-instructed group
Participants in this group will receive Oura Rings and access to AI-based exercise guidance. They are instructed to follow received instructions, but they are blinded to their outcome measure (CVA).
Exercise
Participant will communicate with a "chatbot-like" proprietary AI to receive exercise instructions. The AI will provide personalized advice according to the user's needs, aiming for 2-3 hours of steady-state zone 2 -effort aerobic exercise. Instructions will also be tailored to the user's exercise preferences and limitations (for example, suggest cycling, if running is not convenient).
Supervised exercise group
Participants in this group receive Oura Rings and are instructed to attend supervised HIIT-cycling sessions twice a week. They are blinded to their outcome measure (CVA).
Exercise
Supervised HIIT -cycling twice a week. Intensities for cycling intervals will are based on the participants fitness-level determined at first visit. Intensity will gradually increase over the 12-week period
Ring-only group
Participants in this group receive Oura Rings but no AI-advice or supervised training. They are blinded to the outcome measure (CVA).
Smart Ring
Participants will only receive an Oura Ring, but will not change anything about their normal physical activity.
Interventions
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Exercise
Participant will communicate with a "chatbot-like" proprietary AI to receive exercise instructions. The AI will provide personalized advice according to the user's needs, aiming for 2-3 hours of steady-state zone 2 -effort aerobic exercise. Instructions will also be tailored to the user's exercise preferences and limitations (for example, suggest cycling, if running is not convenient).
Exercise
Supervised HIIT -cycling twice a week. Intensities for cycling intervals will are based on the participants fitness-level determined at first visit. Intensity will gradually increase over the 12-week period
Smart Ring
Participants will only receive an Oura Ring, but will not change anything about their normal physical activity.
Eligibility Criteria
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Inclusion Criteria
30 Years
65 Years
ALL
Yes
Sponsors
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Kuopio Research Institute of Exercise Medicine
OTHER
Pauli Ohukainen
INDUSTRY
Responsible Party
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Pauli Ohukainen
Senior Research Scientist
Locations
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Kuopio Institute of Exercise Medicine
Kuopio, Northern Savonia, Finland
Countries
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Other Identifiers
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207/13.00/2024
Identifier Type: -
Identifier Source: org_study_id