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Exercise Induced QT Interval Changes in Response to Intermittent and Continuous Graded Exercise Tests

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ClinicalTrials.gov Identifier: NCT04005027
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : June 11, 2020
Sponsor:
Collaborators:
Sheffield Hallam University
Newcastle University
Teesside University
Information provided by (Responsible Party):
Will Evans, University of Sunderland

Brief Summary:
Long QT syndrome (LQTS) is an inherited heart defect where the heart takes longer to recover between beats. LQTS is a known condition predisposing young footballers to sudden cardiac death (SDC). The existence of LQTS can be established by measuring the QT interval in an electrocardiogram (ECG). Currently pre-participation cardiac screening is performed in young athletes but players may only be screened at 16 years old using only a resting ECG, and a medical check including a questionnaire on family and medical history. However, the sensitivity and specificity of the screening to investigate underlying causes of SCD could be improved with the addition of an exercise stress test or cardiopulmonary exercise test (CPET). Certain abnormalities in the heart may only become apparent when the heart has been stressed (e.g. via exercise). This is particularly important as in young athletes these abnormal rhythms manifest during rest and recovery rather than at peak exercise. The CPET measures changes in the ECG in response to exercise that increases in intensity in a continuous manner until the participant cannot exercise any long. However, football is characterised by high- intensity bouts of exercise interspersed with low-intensity bouts or pauses. Therefore, the continuous test does not reflect the movement patterns of football and may not stress the cardiovascular system in a similar manner. To address this, intermittent graded exercise tests have been developed to reflect the intermittent movement pattern. As yet there is limited evidence on whether there are any differences in ECG changes during intermittent exercise. Specifically, it is not clear how an intermittent movement pattern might affect the QT interval.

Condition or disease Intervention/treatment Phase
Qt Interval, Variation in Other: Intermittent graded exercise test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The investigators will use a replicated randomised repeated measures crossover design in which the participants will be randomised to different sequences of four experimental conditions
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Exercise Induced Inter-individual Responses in QT Interval Duration and Dispersion During and Following Intermittent and Continuous Graded Exercise Tests in Young Male Football Players
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intermittent graded exercise (INT)
The intermittent graded exercise test (INT) increase treadmill speed incrementally using three minute stage duration on a motorised treadmill. However, the speed within each three minute exercise bout will vary every 30 s between the target speed, and a complete pause for 30 s. The acceleration of the treadmill belt will be set to its maximum capability.
Other: Intermittent graded exercise test
Participants will run on a treadmill until volitional exhaustion. The speed of the treadmill belt will increase incrementally every 3 minutes. Within each 3 minute stage the speed will vary between the target speed and a complete pause (e.g target speed = 8 km/hr)

Active Comparator: Continuous graded exercise (CONT)
The continuous graded exercise test (CONT) will increase treadmill speed incrementally using three minute stage duration on a motorised treadmill
Other: Intermittent graded exercise test
Participants will run on a treadmill until volitional exhaustion. The speed of the treadmill belt will increase incrementally every 3 minutes. Within each 3 minute stage the speed will vary between the target speed and a complete pause (e.g target speed = 8 km/hr)




Primary Outcome Measures :
  1. QT interval duration [ Time Frame: Measured during exercise, and immediately following exercise (6 min recovery) ]
    Duration of the QT interval calculated in each 3 minute stage using various algorithms


Secondary Outcome Measures :
  1. Maximal/ Peak Oxygen Uptake [ Time Frame: End of exercise (final workload stage) taken as highest value over 30 second average ]
    Maximum or peak value of oxygen (L/ min) consumed

  2. Ventilatory threshold [ Time Frame: During exercise determined using V slope method (10 second, and middle 5 of 7 averages) ]
    Point during exercise at which ventilation starts to increase at a faster rate than Oxygen consumed



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Ages Eligible for Study:   16 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male soccer players
  • Must be participating in ~3 - 6 h of soccer training per week as part of a soccer academy or regional training centre (RTC)

Exclusion Criteria:

  • More than one coronary artery disease risk factor
  • At least one cardiovascular, respiratory or metabolic disease.
  • Have suffered from a lower limb musculoskeletal injury in the past 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005027


Contacts
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Contact: Will Evans, PhD +44 (0)191 515 ext 3134 will.evans@sunderland.ac.uk

Locations
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United Kingdom
Sunderland University Recruiting
Sunderland, Tyne And Wear, United Kingdom, SR1 3SD
Contact: Will Evans, PhD       will.evans@sunderland.ac.uk   
Sub-Investigator: Simon Nichols, PhD         
Sub-Investigator: Chris Eggett, PhD         
Sub-Investigator: Greg Atkinson, PhD         
Sponsors and Collaborators
University of Sunderland
Sheffield Hallam University
Newcastle University
Teesside University
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Responsible Party: Will Evans, Principle Investigator, University of Sunderland
ClinicalTrials.gov Identifier: NCT04005027    
Other Study ID Numbers: LQT004291
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Will Evans, University of Sunderland:
QT interval
Intermittent Exercise
Continuous Exercise
Cardiac
Electrocardiogram