The Effect of Physical Fatigue on Lower Limb Functional Performance Tests in a Healthy Population
Primary Purpose
Physical Fatigue, Return to Sport, Injury Prevention
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Physical Fatigue
Control
Sponsored by
About this trial
This is an interventional prevention trial for Physical Fatigue
Eligibility Criteria
Inclusion Criteria:
- Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal disorders)
- Male and female
- No medication
- Non-smoker
- Between 18 and 35 years old
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Vrije Universiteit Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Physical Fatigue Condition
Control Condition
Arm Description
Outcomes
Primary Outcome Measures
Single-leg hop test
Single-leg hop test for distance performance
Vertical jump test
Vertical jump height performance
Y-balance test
Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions.
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.
Secondary Outcome Measures
Mental fatigue Visual Analogue Scale (M-VAS)
Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
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)
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).
Blood lactate
Capillary blood will be collected at the ear lobe for the determination of blood lactate (determined enzymatically)
Blood glucose
Capillary blood will be collected at the ear lobe for the determination of blood glucose concentration
Blood pressure
Objective measure of blood pressure via eletronic blood pressure measuring device
Full Information
NCT ID
NCT04029935
First Posted
July 18, 2019
Last Updated
February 5, 2020
Sponsor
Vrije Universiteit Brussel
1. Study Identification
Unique Protocol Identification Number
NCT04029935
Brief Title
The Effect of Physical Fatigue on Lower Limb Functional Performance Tests in a Healthy Population
Official Title
The Influence of Acute Physical Fatigue on Functional Performance Tests of the Lower Limb in a Healthy Population
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 19, 2019 (Actual)
Primary Completion Date
February 3, 2020 (Actual)
Study Completion Date
February 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Fatigue, Return to Sport, Injury Prevention, Functional Performance
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical Fatigue Condition
Arm Type
Experimental
Arm Title
Control Condition
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Physical Fatigue
Intervention Description
Maximal cycling effort for 30s (Wingate modified)
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
time-matched task (sitting on the bike without pedalling)
Primary Outcome Measure Information:
Title
Single-leg hop test
Description
Single-leg hop test for distance performance
Time Frame
Change in single-leg hop test for distance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Title
Vertical jump test
Description
Vertical jump height performance
Time Frame
Change in vertical jump height performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Title
Y-balance test
Description
Balance and reach performance; participants have to maintain their balance while reaching as far as possible along 3 different directions.
Time Frame
Change in Y-balance performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Title
Balance-reaction time test
Description
Balance and reaction time performance; participants have to maintain their balance while reacting as fast as possible in 3 different directions.
Time Frame
Change in balance and reaction time performance: from baseline and 20 minutes after baseline (immediately after the assigned interventions)
Secondary Outcome Measure Information:
Title
Mental fatigue Visual Analogue Scale (M-VAS)
Description
Subjective measure of mental fatigue (0-10cm; 0 = no mental fatigue; 10 = maximal mental fatigue)
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)
Title
Perception of effort (Session RPE)
Description
Subjective measure of effort after completion of the test battery (scale from 0 to 10; 0 = very very easy; 10 = maximal effort)
Time Frame
Change in session RPE: at baseline (immediately after the first test battery), 15 min after baseline (immediately after the final test battery)
Title
Self-reported motivation
Description
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).
Time Frame
At baseline: prior to the first test battery
Title
Blood lactate
Description
Capillary blood will be collected at the ear lobe for the determination of blood lactate (determined enzymatically)
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)
Title
Blood glucose
Description
Capillary blood will be collected at the ear lobe for the determination of blood glucose concentration
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)
Title
Blood pressure
Description
Objective measure of blood pressure via eletronic blood pressure measuring device
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal disorders)
Male and female
No medication
Non-smoker
Between 18 and 35 years old
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romain Meeusen, Professor
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1050
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effect of Physical Fatigue on Lower Limb Functional Performance Tests in a Healthy Population
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