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Health, SubjectiveNCT05361876

Thermographic Analysis of Hemodynamics Changes Through & Following Wingate Test

An observational study of Health, Subjective, run by Tel Aviv University at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Remote sensing and measurements of hemodynamic changes in blood flow for Wingate Anaerobic test using a novel image processing algorithm. The algorithm calculates the heat distribution from the thermal images and assesses the changes in blood flow and temperatures in the torso and legs for each individual participant. Read more about this study

Who is it for?
Ages 18 to 38 yearsHealthy volunteers can take part
Conditions the study is for
Health, Subjective
How many people
24 participants
Where
1 siteIsrael
Study dates
1 Mar 2021to 13 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

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 18 to 38 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: Israeli volunteers

Who may be able to join

  • Age 18 up to 38 years old
  • Good health record
  • Sports experience of minimum 2 years

Who cannot join

  • Recorded health issues
  • Sedentary type people

Trial locations and contacts

1 site in 1 country.

Israel1 site
  • Tel Aviv University

    Tel Aviv, POBox 39040,, 6997801

Other trials in Israel

About this study

Official title: Remote Sensing and Measurements of Hemodynamic Changes in Blood Flow for Wingate Anaerobic Test Using a Novel Image Processing Algorithm.

Remote sensing and measurements of hemodynamic changes in blood flow for Wingate Anaerobic test using a novel image processing algorithm. The algorithm calculates the heat distribution from the thermal images and assesses the changes in blood flow and temperatures in the torso and legs for each individual participant.

Read the detailed description

Remote sensing and measurements of hemodynamic changes in blood flow during and following the Wingate Anaerobic test using Infra-Red (IR) cameras with novel image processing algorithms. The algorithm calculates the heat distribution from the thermal images and computes the changes in temperatures measured in the torso and that measured in the lower limbs before the test, immediately after, and during 10 minutes recovery period.

Background Thermal imaging The human body is self-generating and regulates the essential levels of temperature for survival. The body core is relatively stable in temperature, but the shell of the body (the surface tissues, which are mainly the skin) forms part of the regulatory process. Body temperature has been used to study many diseases where skin temperature can depict the presence of inflamation in underlying tissues, or where blood flow is increased or decreased because of a clinical abnormality. Thermal imaging has been investigated for numerous medical applications. Several studies reviewed medical thermography [1-3]. Thermal imaging has been investigated for bowel ischemia [4], fever screening [5], diabetic foot, vascular disorder [6], thermoregulation study [7], and breast cancer [8].

Wingate Test In the last 50 years, the Wingate Test is considered to be a common standard for the assessment of the anaerobic capability of athletes. The test is usually performed on computerized stationary bikes, while the participant has to pedal as hard as possible for only 30 seconds at resistance equivalent to 0.075 of their body weights (3).

A previous study (4) has shown a high correlation between the effective power generated and the hemodynamic changes between the leg muscles and the thoracic area of the participant.

Acute hemodynamic changes are the result of intensive vasodilation of metarterioles surrounding the main leg muscles and heavy blood perfusion. The massive blood flow in these areas causes congestion and slows the venous return to the heart.

During this phase, we expect to see significant temperature change between the warm legs, and relatively cooler heart (torso). As the recovery phase progress, we expect to see the legs cool down and the torso warms up until homeostasis is reached.

Thermal imaging and analysis The thermal imaging analysis will be performed using MATLAB software to extract two main features: mean temperature and the entropy, in a selected region-of-interest (ROI). First, the thermal image parameters will be stored in an EXCEL file as a two-dimensional matrix of temperature values. Then, the image (CSV file) is read to the program and the entire matrix is divided into the maximal temperature in the image. This yields a set of normalized temperatures in which the maximal value is 1 and which will be measured at rest, before the Wingate test has been performed. (This normalization is required to obtain correct entropy values using the MATLAB command.) The image is then resized fourfold in each axis and the result is displayed to the user. The user manually selects from this image a rectangular region, and the program extracts the mean value and the entropy of this region. The obtained mean value is multiplied by the maximal temperature in the original image (before normalization) to get the actual mean temperature (rather than the normalized temperature) in the selected ROI.

The main study goal suggests a correlation between the power generated during the 30 seconds of the Wingate Test and the temperature difference between the hot legs and relatively cold torso.

Method: 16 - 20 participants (10 men + 10 Women) healthy, age: 18-38, with some sports experience.

Candidates will be screened by questionnaire + verbal interview, and then they'll sign the Voluntary Informed Consent form (copy attached). Each participant will do his test alone for about one hour.

Test procedure: 5 minutes of warm-up, 2 minutes rest, ½ minute test, 10-15 minutes staying relaxed on the bike while the IR cameras are taking photographs synchronously every minute.

Data gathering: 3 IR cameras (ONE Pro) will be fixed on 3 tripods, one for each leg, and one for the torso photographing. A Voice recorder will record every individual test completely.

Data analysis The picture analysis will provide us with average (right \& left) legs and torso temperatures every minute from test start and 15 minutes later.

The SRM® bike computer will produce a power graph over 30 seconds of the test + Heart Rate recording of the participant for 15 minutes.

Assuming a positive correlation between the average output power, and the temperature difference (legs vs torso), we'll draw a graph of all participants.

Additional outcome results: Time required to full recovery - homeostasis, Heart Rate (HR) changes during recovery time. We may compare these additional results to the main correlation graph.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05361876
Study groupRoleWhat they receive
Young MaleHealthy men with some sport experience
Young FemaleHealthy female with some sport experience

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Temperatures of face, torso and legs, during and following Wingate Tests

    The calculated skin area temperatures, following the sensing and measurements of temperature changes during and following the Wingate Anaerobic Test, using a novel image processing algorithm. The algorithm calculates the heat distribution from the thermal images and assesses the temperature changes in the face, torso, and legs of each individual participant.

    Measured: 30 minutes

Secondary outcomes (2)
  1. Participant's maximum anaerobic legs power on SRM® bicycles

    This specific Wingate test is performed on SRM® stationary bicycles. SRM computer adjusts the bicycle's resistance to match the maximum capability of the participant while measuring and recording the applied power in watts, over a period of 30 seconds.

    Measured: 30 seconds

  2. Time required to full recovery - homeostasis

    Measuring the time from test end, until hemodynamics homeostasis returns

    Measured: 10 - 15 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2022
  2. Study start1 Mar 2021
  3. Primary completion13 Sep 2021
  4. Study completion13 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05361876
Sponsor's protocol ID
TAU BioMed 123456
Status last verified
May 2022
First submitted
25 Apr 2022
Last updated
12 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Coded list for all participants. Data per participant will include: Performed power, Heart rate, body temperature map

Questions about this trial

What is this clinical trial studying?

An observational study of Health, Subjective, run by Tel Aviv University at 1 site in Israel.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 12 May 2022. 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 Israel. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Temperatures of face, torso and legs, during and following Wingate Tests (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 May 2022.

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