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| Name | Class |
|---|---|
| Kuopio Research Institute of Exercise Medicine | OTHER |
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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:
Participants will:
In addition, the study contains questionnaires investigating the participants' experiences related to lifestyle changes.
This is a single-site, 12-week randomized, controlled trial (RCT) consisting of three groups (N = 55 per group):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-instructed group | Experimental | 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). |
|
| Supervised exercise group | Active Comparator | 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). |
|
| Ring-only group | Other | Participants in this group receive Oura Rings but no AI-advice or supervised training. They are blinded to the outcome measure (CVA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial stiffness, clinical reference | Measurement of carotid-femoral pulse-wave velocity (PWV) using the Complior device (Alam Medical) | Three months |
| VO2max | Maximal oxygen consumption measured while cycling with an ergometer (Ergoselect 4, Ergoline GmbH, Germany), and VO2max will be measured by the breath-by-breath method (Vyntus CPX, Vyaire Medical, USA) | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated PWV | Estimation of PWV using Oura Ring's proprietary photophletysmogram -based algorithm | Three months |
| Change in Cardiovascular Age | The delta (change) in Oura Ring's proprietary Cardiovascular Age metric, which is expressed as a difference between their chronological age and cardiovascular age (units are plus- and minus- age years; e.g. -3 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight | Difference between baseline- and post-intervention weight (measured by Inbody 720 -device, South Korea) | Three months |
| Change in body fat | Difference between baseline- and post-intervention body fat mass (measured by Inbody 720 -device, South Korea) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kuopio Institute of Exercise Medicine | Kuopio | Northern Savonia | 70210 | Finland |
IPD sharing plan will be updated pending the Sponsor's (Ouraring ltd) finalization of the relevant data sharing standards and practices
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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Note: Participants are blinded to the outcome measure (CVA) on their Oura App. Outcomes are analyzed by blinded researchers not actively involved in data collection.
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| Exercise | Behavioral | 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 | Device | Participants will only receive an Oura Ring, but will not change anything about their normal physical activity. |
|
| Three months |
| Three months |
| Change in muscle mass | Difference between baseline- and post-intervention muscle mass (measured by Inbody 720 -device, South Korea) | Three months |