FatigueNCT04531891
Utility and Validity of a High-intensity, Intermittent Exercise Protocol
A study testing Fatigue protocol in people with Fatigue, run by University Ghent at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Fatigue protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Sep 2020to 19 Nov 2021
- Phase
- Interventional
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatigue
- Being tested
- Fatigue protocol
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue protocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| All-out, high-intensity, intermittent exercise protocol | Experimental | Not described Receives: Other: Fatigue protocol |
| 5 min, high-intensity, intermittent exercise protocol | Experimental | Not described Receives: Other: Fatigue protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate, expressed in beats per minute
Measured: 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
Isokinetic dynamometry of the quadriceps muscle
Measured: This parameter will be monitored 10 minutes before the start of the fatigue protocol
Isokinetic dynamometry
Isokinetic dynamometry of the quadriceps muscle
Measured: This parameter will be monitored immediately after completion of the protocol
Isokinetic dynamometry
Isokinetic dynamometry of the quadriceps muscle
Measured: This parameter will be monitored 15 minutes after completion of the protocol
Isokinetic dynamometry
Isokinetic dynamometry of the quadriceps muscle
Measured: This parameter will be monitored 30 minutes after completion of the protocol
Blood lactate level
Blood lactate level, expressed in millimol per liter
Measured: This parameters will be monitored 10 minutes before the start of the fatigue protocol
Blood lactate level
Blood lactate level, expressed in millimol per liter
Measured: This parameters will be monitored 10 minutes after completion of the protocol
BORG
BORG-score, indicating the rate of perceived exertion for legs and breathlessness
Measured: This parameters will be continuously monitored 10 minutes before the start of the fatigue protocol until 30 minutes after completion of the protocol
Secondary outcomes (1)
Circuit time
Time to perform the fatigue protocol
Measured: Time will be recorded immediately after completion of the fatigue protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start7 Sep 2020
- Primary completion30 Jun 2021
- Study completion19 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will randomly be assigned to two different fatigue protocols, on separate days. The first protocol is a high-intensity, intermittent exercise protocol and will be performed until complete exhaustion. The second protocol is a time-based variant of the previous protocol and will be performed during 5 minutes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04531891
- Sponsor's protocol ID
- BC-07679
- Status last verified
- Nov 2021
- First submitted
- 13 Aug 2020
- Last updated
- 22 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is not yet decided.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility and Validity of a High-intensity, Intermittent Exercise Protocol in Male Jumping Athletes
- ClinicalTrials.gov ID
- NCT04531891
- Acronym / sponsor ID
- BC-07679
- Conditions
- Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 7 Sep 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 19 Nov 2021 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Each participant will randomly be assigned to two different fatigue protocols, on separate days. The first protocol is a high-intensity, intermittent exercise protocol and will be performed until complete exhaustion. The second protocol is a time-based variant of the previous protocol and will be performed during 5 minutes.
| Arm | Type | Receives |
|---|---|---|
| All-out, high-intensity, intermittent exercise protocol | Experimental | Other: Fatigue protocol |
| 5 min, high-intensity, intermittent exercise protocol | Experimental | Other: Fatigue protocol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Women
- <18 years
- >45 years
- other sports than volley- and basketball
- elite players
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigue protocolDuring 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. | Other | 5 min, high-intensity, intermittent exercise protocol, All-out, high-intensity, intermittent exercise protocol |
Primary outcome
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
Heart rate, expressed in beats per minute
Isokinetic dynamometry
Time frame: This parameter will be monitored 10 minutes before the start of the fatigue protocol
Isokinetic dynamometry of the quadriceps muscle
Isokinetic dynamometry
Time frame: This parameter will be monitored immediately after completion of the protocol
Isokinetic dynamometry of the quadriceps muscle
Isokinetic dynamometry
Time frame: This parameter will be monitored 15 minutes after completion of the protocol
Isokinetic dynamometry of the quadriceps muscle
Isokinetic dynamometry
Time frame: This parameter will be monitored 30 minutes after completion of the protocol
Isokinetic dynamometry of the quadriceps muscle
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
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
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
BORG-score, indicating the rate of perceived exertion for legs and breathlessness
1 secondary outcome
Circuit time
Time frame: Time will be recorded immediately after completion of the fatigue protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: Undecided. This is not yet decided.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigue protocol in people with Fatigue, run by University Ghent at 1 site in Belgium.
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 5 inclusion and 7 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 22 Nov 2021. 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 Belgium. 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?
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). The study lists 8 primary outcomes in all. 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 22 Nov 2021; AzTrials last refreshed its copy on 30 Oct 2026.