Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)
This study is looking at new ways to understand how well your heart and lungs cope with everyday tasks. Currently, detailed measurements often require special tests in a hospital. We want to see if wearable devices, like those you might wear on your wrist, can accurately estimate these measurements using information from your body, such as your movements and heart rhythm. The main goal is to collect information to develop and test a computer program that can interpret these signals. This could eventually provide a simpler way for people to monitor their heart and lung fitness at home. We plan to involve 1000 volunteers, including healthy individuals and those already having standard heart and lung tests.
At a glance
What is this study about?
Imagine being able to get a good idea of how well your heart and lungs are working, simply by wearing a device in your daily life? That's what this study is exploring. We know that certain measurements, like how much oxygen your body uses during exercise (often called VO2Max), tell us a lot about your overall fitness and heart health. Currently, to get a very accurate reading, you usually need to do a special exercise test in a clinic, where you might wear a mask and have sensors attached.
This study is trying to find a simpler way. We believe that information gathered by everyday wearable devices – like smartwatches or fitness trackers that measure your movement and heart activity – might be used to estimate these important heart and lung measurements. We're going to collect data from volunteers to help build and test a special computer program. This program will be designed to learn from these signals and hopefully estimate how effectively your body uses oxygen.
Ultimately, if this project is successful, it could lead to new tools that make it easier for people to understand and monitor their heart and lung health outside of a hospital setting. This could be particularly helpful for managing long-term conditions or simply staying on top of your general fitness.
Key takeaways
- This study evaluates if wearable sensors can estimate heart and lung fitness.
- It aims to simplify how we measure crucial health indicators.
- Participation involves wearing extra sensors during a routine heart and lung test.
- No change to your current medical care or medicines.
- Your involvement helps develop future health monitoring tools.
- Low risk, no direct personal benefit, and you can withdraw anytime.
Who may be eligible?
To join this study, you need to be at least 18 years old and willing to follow the study's instructions. You also need to be someone who is already scheduled to have a specific heart and lung exercise test (called a Cardiopulmonary Exercise Test or CPET) as part of your usual medical care, or you can be a healthy person between 18 and 80 years old.
There are some reasons why you might not be able to join. For example, if you are pregnant, breastfeeding, or have recently given birth, you cannot participate. Also, if you have certain types of heart rhythm problems or an implanted device that affects your heart's natural rhythm – like some pacemakers – you might not be suitable.
We also can't include you if you have a special device called a Barostim or a similar electrical device in your body. People with certain complex conditions that affect the heart from birth are also generally excluded, though there might be exceptions decided by the study doctor. Finally, if you have an allergy to adhesive medical tape or any health issue that might prevent you from taking part fully or exercising enough for the test, you won't be able to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you aged 18 or over?
- Are you already scheduled for a Cardiopulmonary Exercise Test (CPET)? (Or are you a healthy adult between 18 and 80?)
- Are you able to follow study instructions?
- Are you NOT pregnant or breastfeeding?
- Do you NOT have certain complex heart conditions or specific implanted electrical devices (like some pacemakers)?
- Are you NOT allergic to adhesive tape?
What does participation involve?
If you decide to take part in this study, you will likely continue with your planned Cardiopulmonary Exercise Test (CPET) as usual. During this test, you'll also wear some additional small, temporary sensors. These sensors will simply record information like your movement and heart rhythm. You won't be asked to change any of your existing medications or treatments.
For healthy participants, you will undertake a CPET and wear these sensors at that time. The study mainly involves collecting this extra data during your scheduled CPET, rather than multiple separate visits. The length of time you'll be involved with the study will generally be quite short, focused around the time of your test. There's no long-term follow-up required after your test.
Potential risks and benefits
Locations (16)
- Mayo Clinic ArizonaVerified postcodeScottsdale, United States· Recruiting
- VA Palo Alto Healthcare SystemVerified postcodePalo Alto, United States· Recruiting
- University of California San FranciscoVerified postcodeSan Francisco, United States· Recruiting
- The Lundquist InstituteVerified postcodeTorrance, United States· Recruiting
- Nemours Cardiac CenterVerified postcodeWilmington, United States· Recruiting
- Memorial Healthcare System, Office of Human ResearchVerified postcodeHollywood, United States· Recruiting
- Mayo Clinic FloridaVerified postcodeJacksonville, United States· Recruiting
- New Generation of Medical ResearchVerified postcodeNaples, United States· Recruiting
- physIQVerified postcodeChicago, United States· Completed
- University of Illinois Hospital & Health Sciences SystemVerified postcodeChicago, United States· Recruiting
- Advocate Aurora Health InstituteVerified postcodeOakbrook Terrace, United States· Completed
- Mayo ClinicVerified postcodeRochester, United States· Recruiting
Common questions
What is a Cardiopulmonary Exercise Test (CPET)?
It's a special exercise test, often done on a bike or treadmill, that measures how well your heart and lungs work together during physical activity.
Will this study change my medical treatment?
No, this study will not change any of your current medical treatments or the care you receive from your doctor.
Do I have to wear special equipment for a long time?
You'll wear some small, temporary sensors during your scheduled heart and lung exercise test. You won't wear them for long periods outside of this test.
Will I find out my personal test results from the study?
The study focuses on developing new methods, so individual results from the new measurements will not generally be shared directly with participants.
What is VO2Max and why is it important?
VO2Max is a measure of how much oxygen your body can use during intense exercise. It's an important indicator of your fitness level and heart health.
How to find out more
Clinical Trials at Prolaio
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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