- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04531891
Utility and Validity of a High-intensity, Intermittent Exercise Protocol
November 19, 2021 updated by: University Ghent
The Utility and Validity of a High-intensity, Intermittent Exercise Protocol in Male Jumping Athletes
The purpose of this study is to identify an exercise-induced fatigue protocol to mimic central and peripheral acute fatigue effects associated with participation in vigorous dynamic sports activities and to understand the expected central (cardiovascular) and peripheral (muscular) impact of this protocol.
Study Overview
Detailed Description
Fatigue-related parameters (BORG, heart rate, blood lactate level, concentric/eccentric force of the quadriceps muscle) will be measured before and after different short-term high-intensity, intermittent exercise protocols.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oost-Vlaanderen
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Gent, Oost-Vlaanderen, Belgium, 9000
- Vakgroep Revalidatiewetenschappen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Men
- ≥ 18 years
- Volley- and basketball, non-elite
- ≥ 3 times per week sports participation
- No acute or overuse low back/lower extremity injuries in the past 6 months
Exclusion Criteria:
- Women
- <18 years
- >45 years
- other sports than volley- and basketball
- elite players
- <3 times per week sports participation
- acute or overuse low back/lower extremity injuries in the past 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All-out, high-intensity, intermittent exercise protocol
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During the fatigue protocol, participants will sprint forward 5 m, cut at a 90° angle, sprint forward another 5 m, and backpedal 5 m.
This activity will be repeated 4 times before participants will complete a series of hurdle activities.
First, they will perform 2-legged jumps over 5 hurdles that are 30 cm high, turn, and repeat the jumps.
Second, they will perform side-stepping exercises over the 5 hurdles.
Third, they will complete four 5-m lateral shuffles.
|
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Experimental: 5 min, high-intensity, intermittent exercise protocol
|
During the fatigue protocol, participants will sprint forward 5 m, cut at a 90° angle, sprint forward another 5 m, and backpedal 5 m.
This activity will be repeated 4 times before participants will complete a series of hurdle activities.
First, they will perform 2-legged jumps over 5 hurdles that are 30 cm high, turn, and repeat the jumps.
Second, they will perform side-stepping exercises over the 5 hurdles.
Third, they will complete four 5-m lateral shuffles.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: This parameters will be continuously monitored 10 minutes before the start of the fatigue protocol until 30 minutes after completion of the protocol
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Heart rate, expressed in beats per minute
|
This parameters will be continuously monitored 10 minutes before the start of the fatigue protocol until 30 minutes after completion of the protocol
|
|
Isokinetic dynamometry
Time Frame: This parameter will be monitored 10 minutes before the start of the fatigue protocol
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Isokinetic dynamometry of the quadriceps muscle
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This parameter will be monitored 10 minutes before the start of the fatigue protocol
|
|
Isokinetic dynamometry
Time Frame: This parameter will be monitored immediately after completion of the protocol
|
Isokinetic dynamometry of the quadriceps muscle
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This parameter will be monitored immediately after completion of the protocol
|
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Isokinetic dynamometry
Time Frame: This parameter will be monitored 15 minutes after completion of the protocol
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Isokinetic dynamometry of the quadriceps muscle
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This parameter will be monitored 15 minutes after completion of the protocol
|
|
Isokinetic dynamometry
Time Frame: This parameter will be monitored 30 minutes after completion of the protocol
|
Isokinetic dynamometry of the quadriceps muscle
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This parameter will be monitored 30 minutes after completion of the protocol
|
|
Blood lactate level
Time Frame: This parameters will be monitored 10 minutes before the start of the fatigue protocol
|
Blood lactate level, expressed in millimol per liter
|
This parameters will be monitored 10 minutes before the start of the fatigue protocol
|
|
Blood lactate level
Time Frame: This parameters will be monitored 10 minutes after completion of the protocol
|
Blood lactate level, expressed in millimol per liter
|
This parameters will be monitored 10 minutes after completion of the protocol
|
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BORG
Time Frame: This parameters will be continuously monitored 10 minutes before the start of the fatigue protocol until 30 minutes after completion of the protocol
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BORG-score, indicating the rate of perceived exertion for legs and breathlessness
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This parameters will be continuously monitored 10 minutes before the start of the fatigue protocol until 30 minutes after completion of the protocol
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Circuit time
Time Frame: Time will be recorded immediately after completion of the fatigue protocol
|
Time to perform the fatigue protocol
|
Time will be recorded immediately after completion of the fatigue protocol
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 7, 2020
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
November 19, 2021
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 25, 2020
First Posted (Actual)
August 31, 2020
Study Record Updates
Last Update Posted (Actual)
November 22, 2021
Last Update Submitted That Met QC Criteria
November 19, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-07679
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
This is not yet decided.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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