Arterial StiffnessGONDOR-ASNCT06644014
Reducing Arterial Stiffness with a Smart Ring and AI-Guided Exercise
A study testing Exercise and Smart Ring in people with Arterial Stiffness and Maximal Oxygen Uptake, run by Pauli Ohukainen at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness, Maximal Oxygen Uptake
- What is being tested?
- Exercise and Smart Ring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteFinland
- Study dates
- 16 Sep 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported moderate intensity physical activity less than 2 hours 30 minutes per week or vigorous intensity physical activity less than 1 hour 15 minutes per week.
Who cannot join
- Coronary artery disease (or other chronic condition preventing safe participation in an exercise intervention), diabetes and moderate/severe hypertension diagnosed by a physician. Inability to use the Oura Ring for some reason (e.g. work-related restrictions) is also considered as exclusion criteria; however, short interruptions (e.g. 1-2 hour work tasks without ring) are possible.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Kuopio Institute of Exercise Medicine
Kuopio, Northern Savonia, 70210
About this study
Official title: Guidance with Oura and AI for Reducing Arterial Stiffness - the GONDOR-AS Trial
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 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?
Read more
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.
Read the 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 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
- Arterial Stiffness, Maximal Oxygen Uptake
- Being tested
- Exercise, Smart Ring
- Keywords
- arterial stiffness, maximal oxygen uptake, HIIT training, Oura Ring, Oura, AI, Artificial Intelligence, Aerobic Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
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).
ExerciseBehavioural
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 RingDevice
Participants will only receive an Oura Ring, but will not change anything about their normal physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Exercise |
| 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). Receives: Behavioral: Exercise |
| 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). Receives: Device: Smart Ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness, clinical reference
Measurement of carotid-femoral pulse-wave velocity (PWV) using the Complior device (Alam Medical)
Measured: 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)
Measured: Three months
Secondary outcomes (2)
Estimated PWV
Estimation of PWV using Oura Ring's proprietary photophletysmogram -based algorithm
Measured: 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).
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start16 Sep 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial StiffnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pauli Ohukainen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kuopio Research Institute of Exercise Medicine
- Responsible party
- Sponsor-investigator, Pauli Ohukainen, Ouraring Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06644014
- Sponsor's protocol ID
- 207/13.00/2024
- Acronym
- GONDOR-AS
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing plan will be updated pending the Sponsor's (Ouraring ltd) finalization of the relevant data sharing standards and practices
Publications
Pentikainen H, Strommer S, Caraker D, Kosonen J, Rantanen A, Hiltunen S, Komulainen P, Simila H, de Zambotti M, Savonen K, Ohukainen P. The Effects of AI-Guided Exercise and a Smart Ring on Arterial Stiffness: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Aug 21;15:e98213. doi: 10.2196/98213.
PubMed 42627713
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guidance with Oura and AI for Reducing Arterial Stiffness - the GONDOR-AS Trial
- ClinicalTrials.gov ID
- NCT06644014
- Acronym / sponsor ID
- GONDOR-AS / 207/13.00/2024
- Conditions
- Arterial Stiffness, Maximal Oxygen Uptake
- Keywords
- arterial stiffness, maximal oxygen uptake, HIIT training, Oura Ring, Oura, AI, Artificial Intelligence, Aerobic Exercise
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Pauli OhukainenIndustry (pharma, biotech, devices)
- Collaborators
- Kuopio Research Institute of Exercise Medicine
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 16 Oct 2024 (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 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 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
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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AI-instructed group | Experimental | Behavioral: ExerciseParticipants 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 | Behavioral: ExerciseParticipants 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 | Device: Smart RingParticipants in this group receive Oura Rings but no AI-advice or supervised training. They are blinded to the outcome measure (CVA). |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Self-reported moderate intensity physical activity less than 2 hours 30 minutes per week or vigorous intensity physical activity less than 1 hour 15 minutes per week.
Key exclusion criteria (1 listed)
- Coronary artery disease (or other chronic condition preventing safe participation in an exercise intervention), diabetes and moderate/severe hypertension diagnosed by a physician. Inability to use the Oura Ring for some reason (e.g. work-related restrictions) is also considered as exclusion criteria; however, short interruptions (e.g. 1-2 hour work tasks without ring) are possible.
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 |
|---|---|---|
| ExerciseParticipant 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). | Behavioural | AI-instructed group |
| ExerciseSupervised 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 | Behavioural | Supervised exercise group |
| Smart RingParticipants will only receive an Oura Ring, but will not change anything about their normal physical activity. | Device | Ring-only group |
Primary outcome
Arterial stiffness, clinical reference
Time frame: Three months
Measurement of carotid-femoral pulse-wave velocity (PWV) using the Complior device (Alam Medical)
VO2max
Time frame: Three months
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)
2 secondary outcomes
Estimated PWV
Time frame: Three months
Change in Cardiovascular Age
Time frame: Three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Derived from this study: PubMed 42627713Pentikainen H, Strommer S, Caraker D, Kosonen J, Rantanen A, Hiltunen S, Komulainen P, Simila H, de Zambotti M, Savonen K, Ohukainen P. The Effects of AI-Guided Exercise and a Smart Ring on Arterial Stiffness: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Aug 21;15:e98213. doi: 10.2196/98213.
- Individual participant dataSharing planned: Undecided. 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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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Smart Ring in people with Arterial Stiffness and Maximal Oxygen Uptake, run by Pauli Ohukainen at 1 site in Finland.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Arterial stiffness, clinical reference (time frame: Three months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06644014, which also lists 1 linked publication.
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 3 Dec 2024; AzTrials last refreshed its copy on 28 Oct 2026.