- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06871943
Can Wearable Technology be Used to Predict Exercise Intensity ((CWTPEI))
Developing a Rationale for the Use of Breathing Frequency and Wearable Foot-pods to Measure Intensity in Cardiac Populations
There is a knowledge gap in the literature around using watts to measure exercise intensity in walking and running, this is largely due to new technological developments. Whereas the relationship is widely recognised and used for cycling in elite to clinical populations.
While the relationship breathing rate and exercise intensity is well established, this are no guidelines using breathing rate as a physiological measure of intensity. New technology may aid to bridge these gaps.
The main aims of the study are: -
Can the relationship between oxygen uptake and watts during incremental exercise Can breathing frequency be used to determine aerobic exercise intensity
The participants will complete two 9 minute incremental accredited exercise tests on the flat around cones and on treadmill at the given speed of walking around the cones. The test will stop at 6.8kph or at participant volition.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The experimental feasibility study involves testing if the wearable technology (Stryd accelerometer) can translate work rate into an accurate measurement of watts (energy produced) within cardiac populations, when compared to V̇o2 consumed. While also testing to see the measured relationship between breathing rate and exercise induced exertion levels. The testing will involve participants working to a sub maximal incremental shuttle walk test pace on treadmill (unto 6.8kph) and following standard procedure on the flat around cones. They will be wearing a Stryd accelerometer attached to their training shoes and Respa breathing monitor attached to their lapel or t-shirt. V̇o2 will be measured using a Cortex Metalyzer 3B. All participants will perform the testing twice in a counter balanced order (i.e participant one will perform the treadmill first, while the next will perform the testing on the flat around cones).
Participants will be recruited from the cardiac rehabilitation team at the University Hospital of the North Midlands.
The pace of the treadmill will be in line with the constant walking pace required to achieve a steady state at each level of the incremental shuttle walk test protocol. The treadmill will not be an incline as normal testing is on flat surface. The Stryd and Respa will be linked to a mobile device where watts and breathing frequency readings will be gathered, progression to the next stage will be at one minute.
Each test lasts for 9 minutes, with a 15-minute recovery period between tests and pre and post exercise tests, participation will take approximately 1 hour. Post testing the participant can remove the device and face mask; while being encouraged to cool down until heart rate is within 20 beats of resting levels but they can leave at any time.
Power will be measured in watts from the Stryd accelerometer, V̇O2 will be measured in ml.kg.min, while respiratory rate will be breaths per minute To remove anomalies from the excel sheet, the watts and breathing frequency readings will be taken from smoothing the data within the last 30 seconds of the level. This will allow the participant to adjust to the change in pace and achieve a steady state of walking. The V̇o2 reading will also be taken in the last 30 seconds with the average of the smoothed data used.
It is anticipated that all participants will not finish the testing up to stage 9, due to volitional fatigue. All data will be reported and recorded, with a n value for each stage, denoting the power and the perceived drop out at each point.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Sam Jones, MSc
- Phone Number: +44 07841390625
- Email: s.jones3@keele.ac.uk
Study Contact Backup
- Name: Dean Burt, PhD
- Phone Number: +44 07967 581009
- Email: d.burt@keele.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Myocardial Infraction in the past 6 months
- Able to walk on a treadmill
- Aged ≥ 18
Exclusion Criteria:
• Injury or condition that impedes normal gait
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Myocardial Infraction
Participants who have suffered a myocardial infraction in the past 6 months and are actively enrolled onto a cardiac rehabilitation programme
|
The participants will walk on the flat around cones placed 9 meters apart inline with the procedure for the incremental shuttle walk test.
They will also walk at a matched speed to the incremental shuttle walk test on a treadmill.
This will be performed in a counter balanced procedure to reduce any benefit of a learning effect.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Can a Stryd accelerometer be used to predict V̇o2max and therefore be used to gather a baseline for exercise prescription in cardiac populations post myocardial infraction.
Time Frame: 1 day of testing, enrolment may be within 1 month prior to the test
|
Develop a regression equation for the use of watts derived from a foot pod to predict vo2.
Assessing watts per kg of body mass against vo2 per kg of body mass, offering insight as to how this population group can use watts to prescribe exercise.
|
1 day of testing, enrolment may be within 1 month prior to the test
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Can a breathing frequency monitor be used to predict aerobic exercise intensity in cardiac populations post myocardial infraction.
Time Frame: 1 day of testing, enrolment may be within 1 month prior to the test
|
Develop a regression equation for the use of breathing frequency to predict vo2.
Assessing breathing frequency against vo2 per kg of body mass, offering insight as to how this population group can use watts to prescribe exercise.
|
1 day of testing, enrolment may be within 1 month prior to the test
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: John Buckley, PhD, Keele University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KeeleU
- RG-0393-24 (Other Identifier: Integrated Research Application System)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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