Reducing Arterial Stiffness with a Smart Ring and AI-Guided Exercise

NCT06644014 | Active Not Recruiting

• 1 other identifier: 207/13.00/2024
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Arterial Stiffness; Maximal Oxygen Uptake

Keywords

arterial stiffness; maximal oxygen uptake; HIIT training; Oura Ring; Oura; AI; Artificial Intelligence; Aerobic Exercise

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Estimated PWV

  Three months

• Change in Cardiovascular Age

  Three months

Other Outcomes (3)

• Change in body weight

  Three months

• Change in body fat

  Three months

• Change in muscle mass

  Three months

Study Arms (3)

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).

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).

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).

Device: Smart Ring

Interventions

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).

AI-instructed group

Smart Ring DEVICE

Participants will only receive an Oura Ring, but will not change anything about their normal physical activity.

Ring-only group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Pauli Ohukainen: lead
• Kuopio Research Institute of Exercise Medicine: collaborator

Study Sites (1)

Kuopio Institute of Exercise Medicine

Kuopio, Northern Savonia, 70210, Finland

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 16, 2024
• Study Start: September 16, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

FI (1)