The Effect of Physical Fatigue on Lower Limb Functional Performance Tests in a Healthy Population

NCT04029935 | Completed

• 1 other identifier: 143201939779
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Fatigue; Return to Sport; Injury Prevention; Functional Performance

Outcome Measures

Primary Outcomes (4)

• Single-leg hop test

  Single-leg hop test for distance performance

  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

  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.

  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.

  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)

  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)

  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

  At baseline: prior to the first test battery

• Blood lactate

  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

  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)

Study Arms (2)

Physical Fatigue Condition

EXPERIMENTAL

Behavioral: Physical Fatigue

Control Condition

PLACEBO COMPARATOR

Behavioral: Control

Interventions

Physical Fatigue BEHAVIORAL

Maximal cycling effort for 30s (Wingate modified)

Physical Fatigue Condition

Control BEHAVIORAL

time-matched task (sitting on the bike without pedalling)

Control Condition

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy (No neurological/cardiorespiratory/psychological/musculoskeletal disorders)
• Male and female
• No medication
• Non-smoker
• Between 18 and 35 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Brussels, 1050, Belgium

Location

Study Officials

• Romain Meeusen, Professor

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr.

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 23, 2019
• Study Start: July 19, 2019
• Primary Completion: February 3, 2020
• Study Completion: February 3, 2020
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)