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Smartwatch fitness test? study aims to replace lab treadmill with wearable sensors

NCT ID NCT05678530

Knowledge-focused Sponsor: Prolaio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 10, 2026 · Updated 3 times

Summary

This study is testing whether wearable sensors, like those in smartwatches, can accurately estimate a key measure of heart and lung fitness called VO2Max during everyday activities. Researchers will collect data from 1,000 participants, including healthy volunteers and patients undergoing standard exercise tests. The goal is to develop a machine learning algorithm that could make fitness tracking more accessible without needing special lab equipment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple way to measure heart and lung fitness using wearable devices, making it easier for people to track their health without needing a lab test.
What could go wrong
This is an early observational study focused on data collection, not a treatment. The algorithm may not be accurate enough for widespread use, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2019

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to comply with protocol procedures and available for the duration of the study. 2. Willing to sign and date informed consent document for study participation. 3. Participant is undergoing the Cardiopulmonary Exercise Test (CPET), or an echocardiogram (Echo), or both CPET and Echo as Standard of Care Exclusion Criteria: 1. Participant is pregnant, lactating or ≤30 days post-partum. 2. Participant has limited or no intrinsic sinus node function (i.e. chronic atrial pacing). • If participant has an indwelling cardiac device and programming cannot be sufficiently ascertained to assure sinus node competence and lack of atrial pacing, the patient should be excluded. 3. Barostim (™) or similar noncardiac electrical pulse generating device in situ. 4. Complex congenital heart disease (even repaired or palliated) with the following exception: • Biventricular physiology without severe valvar dysfunction (e.g. free pulmonary insufficiency) at the discretion of the investigator. 5. Any history of allergy to adhesive 6. Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures and/or reach a respiratory exchange ratio of 1.0, or perform a maximal CPET in the judgement of the investigator, and/or any limitations pertaining to obtaining a complete Echo

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiopulmonary

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Advocate Aurora Health Institute

    COMPLETED

    Oakbrook Terrace, Illinois, 60181, United States

  • Baylor Scott & White Research Institute

    RECRUITING

    Dallas, Texas, 75246, United States

  • Baylor Scott & White The Heart Hospital - Plano

    RECRUITING

    Plano, Texas, 75093, United States

  • Eastern Health Cardiac Rehabilitation

    RECRUITING

    St. John's, Newfoundland and Labrador, A1N3J5, Canada

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Arizona

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Memorial Healthcare System, Office of Human Research

    RECRUITING

    Hollywood, Florida, 33021, United States

  • Nemours Cardiac Center

    RECRUITING

    Wilmington, Delaware, 19803, United States

  • New Generation of Medical Research

    COMPLETED

    Naples, Florida, 34116, United States

  • The Lundquist Institute

    RECRUITING

    Torrance, California, 90502, United States

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94143, United States

  • University of Illinois Hospital & Health Sciences System

    COMPLETED

    Chicago, Illinois, 60608, United States

  • VA Palo Alto Healthcare System

    RECRUITING

    Palo Alto, California, 94304, United States

  • physIQ

    COMPLETED

    Chicago, Illinois, 60606, United States

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