Physical FatigueNCT04029935
The Effect of Physical Fatigue on Lower Limb Functional Performance Tests in a Healthy Population
A study testing Physical Fatigue in people with Physical Fatigue and Return to Sport, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial summary
The main objective of this project is: 1. To assess the influence of physical fatigue on a return-to-play test battery in a healthy population. In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Fatigue, Return to Sport, Injury Prevention
- What is being tested?
- Physical Fatigue
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jul 2019to 3 Feb 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal disorders)
- Male and female
- No medication
- Non-smoker
- Between 18 and 35 years old
Who cannot join
- Back and/or lower extremity injuries during the past 6 months
- Bone/joint abnormalities
- Dizziness, history of loss of consciousness, any inner ear disorders
- Nervous system disorders or dysfunctions
- Uncorrected eye disorders/dysfunctions
- Illness
Show all 9Show fewer
- Use of medication or any kind of drugs
- Use of alcohol, caffeine and heavy efforts 24 hours before each trial
- Not eating the same meal the night before and the morning of each experimental trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Acute Physical Fatigue on Functional Performance Tests of the Lower Limb in a Healthy Population
The main objective of this project is:
- To assess the influence of physical fatigue on a return-to-play test battery in a healthy population. In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population).
Read more
The researchers will use a randomized, placebo controlled, counter-balanced, cross-over design. Twenty healthy subjects will visit the lab 3 times. On the first visit (familiarisation trial), the investigators will collect the participants' characteristics. The participants will also be familiarized to the procedures and materials of the experiment during this first visit. The second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a pre-test checklist, a mental fatigue scale (M-VAS) and motivation scale. In the mean time a little blood will be collected from the ear lobe to determine lactate and glucose levels; also, blood pressure will be checked. Next, the subjects will carry out a functional test battery (hop test, vertical jump test, Y-balance test, and a balance reaction-time test). Session rate of perceived exertion (SRPE) is measured to indicate how fatigued the participants feel due to the test battery; also, M-VAS is collected once more, as well blood lactate, glucose and blood pressure. These measures are followed by either a physical fatigue inducing task (Modified 30 seconds Wingate protocol) or time-matched control task (sitting on the bike without pedalling). Afterwards, researchers will collect blood lactate, glucose and blood pressure two times more; participants have to fill in M-VAS (2x), perform the same test battery, and fill in the SRPE scale one more time.
Heart frequency will be measured continuously during the trials.
- Being tested
- Physical Fatigue, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical FatigueBehavioural
Maximal cycling effort for 30s (Wingate modified)
ControlBehavioural
time-matched task (sitting on the bike without pedalling)
| Study group | Role | What they receive |
|---|---|---|
| Physical Fatigue Condition | Experimental | Not described Receives: Behavioral: Physical Fatigue |
| Control Condition | Placebo comparator | Not described Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single-leg hop test
Single-leg hop test for distance performance
Measured: Change in single-leg hop test for distance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Vertical jump test
Vertical jump height performance
Measured: Change in vertical jump height performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Y-balance test
Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions.
Measured: Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Balance-reaction time test
Balance and reaction time performance; participants have to maintain their balance while reacting as fast as possible in 3 different directions.
Measured: Change in balance and reaction time performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Secondary outcomes (6)
Mental fatigue Visual Analogue Scale (M-VAS)
Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
Measured: Change in M-VAS: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
Perception of effort (Session RPE)
Subjective measure of effort after completion of the test battery (scale from 0 to 10; 0 = very very easy; 10 = maximal effort)
Measured: Change in session RPE: at baseline (immediately after the first test battery), 15 min after baseline (immediately after the final test battery)
Self-reported motivation
Subjective measure of motivation assessed with the self-reported Motivation scale of Matthews et al.. (the questionnaire measures 2 constructs: intrinsic motivation and task succes motivation;the questionnaire comprises 14 questions scored from 0 to 4 [0 = not all motivated, while 4 = maximally motivated]. Each construct contains 7 questions).
Measured: At baseline: prior to the first test battery
Blood lactate
Capillary blood will be collected at the ear lobe for the determination of blood lactate (determined enzymatically)
Measured: Change in blood lactate: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
Blood glucose
Capillary blood will be collected at the ear lobe for the determination of blood glucose concentration
Measured: Change in blood glucose: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
Blood pressure
Objective measure of blood pressure via eletronic blood pressure measuring device
Measured: Change in blood pressure: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study start19 Jul 2019
- Primary completion3 Feb 2020
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romain Meeusen, Vrije Universiteit Brussel
- Investigators
- Romain Meeusen, Professor, Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04029935
- Sponsor's protocol ID
- 143201939779
- Status last verified
- Feb 2020
- First submitted
- 18 Jul 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Acute Physical Fatigue on Functional Performance Tests of the Lower Limb in a Healthy Population
- ClinicalTrials.gov ID
- NCT04029935
- Acronym / sponsor ID
- 143201939779
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 19 Jul 2019 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 23 Jul 2019 (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 main objective of this project is:
- To assess the influence of physical fatigue on a return-to-play test battery in a healthy population. In a later stage, these experiments could be carried out in a clinical context (e.g. in an ankle sprain population).
The researchers will use a randomized, placebo controlled, counter-balanced, cross-over design. Twenty healthy subjects will visit the lab 3 times. On the first visit (familiarisation trial), the investigators will collect the participants' characteristics. The participants will also be familiarized to the procedures and materials of the experiment during this first visit. The second and third visit contain the experimental setup and will proceed as follows: first, the participants will fill in a pre-test checklist, a mental fatigue scale (M-VAS) and motivation scale. In the mean time a little blood will be collected from the ear lobe to determine lactate and glucose levels; also, blood pressure will be checked. Next, the subjects will carry out a functional test battery (hop test, vertical jump test, Y-balance test, and a balance reaction-time test). Session rate of perceived exertion (SRPE) is measured to indicate how fatigued the participants feel due to the test battery; also, M-VAS is collected once more, as well blood lactate, glucose and blood pressure. These measures are followed by either a physical fatigue inducing task (Modified 30 seconds Wingate protocol) or time-matched control task (sitting on the bike without pedalling). Afterwards, researchers will collect blood lactate, glucose and blood pressure two times more; participants have to fill in M-VAS (2x), perform the same test battery, and fill in the SRPE scale one more time.
Heart frequency will be measured continuously during the trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical Fatigue Condition | Experimental | Behavioral: Physical Fatigue |
| Control Condition | Placebo comparator | Behavioral: Control |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal disorders)
- Male and female
- No medication
- Non-smoker
- Between 18 and 35 years old
Key exclusion criteria (9 listed)
- Back and/or lower extremity injuries during the past 6 months
- Bone/joint abnormalities
- Dizziness, history of loss of consciousness, any inner ear disorders
- Nervous system disorders or dysfunctions
- Uncorrected eye disorders/dysfunctions
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 |
|---|---|---|
| Physical FatigueMaximal cycling effort for 30s (Wingate modified) | Behavioural | Physical Fatigue Condition |
| Controltime-matched task (sitting on the bike without pedalling) | Behavioural | Control Condition |
Primary outcome
Single-leg hop test
Time frame: Change in single-leg hop test for distance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Single-leg hop test for distance performance
Vertical jump test
Time frame: Change in vertical jump height performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Vertical jump height performance
Y-balance test
Time frame: Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions.
Balance-reaction time test
Time frame: Change in balance and reaction time performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Balance and reaction time performance; participants have to maintain their balance while reacting as fast as possible in 3 different directions.
6 secondary outcomes
Mental fatigue Visual Analogue Scale (M-VAS)
Time frame: Change in M-VAS: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
Perception of effort (Session RPE)
Time frame: Change in session RPE: at baseline (immediately after the first test battery), 15 min after baseline (immediately after the final test battery)
Self-reported motivation
Time frame: At baseline: prior to the first test battery
Blood lactate
Time frame: Change in blood lactate: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
Blood glucose
Time frame: Change in blood glucose: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
Blood pressure
Time frame: Change in blood pressure: at baseline, 10 min after baseline (immediately after the first test battery), 15 min after baseline (immediately after the assigned interventions) and 25 min after baseline (immediately after the final test battery)
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 6 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Romain Meeusen, Professor principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Fatigue in people with Physical Fatigue and Return to Sport, run by Vrije Universiteit Brussel 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 9 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 6 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
Single-leg hop test (time frame: Change in single-leg hop test for distance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)). The study lists 4 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 6 Feb 2020.