The Effect of Physical Fatigue on Different Balance Tests and Brain Activity in a Healthy Population

NCT ID: NCT04030390

Last Updated: 2020-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-19
• Study Completion Date: 2020-03-09

Brief Summary

The main objective of this project is:

1. To assess the influence of physical fatigue on brain functioning during a balance and reaction time task 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 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 Y-balance test and balance reaction time test, and fill in the SRPE scale one more time. Heart frequency and EEG will be measured continuously during the trials.

Conditions

Physical Fatigue; Return to Sport; Injury Prevention; EEG; Brain Activity; Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Physical Fatigue Condition

Group Type: EXPERIMENTAL

Physical Fatigue

Intervention Type: BEHAVIORAL

Maximal cycling effort for 30s (Wingate modified)

Control Condition

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: BEHAVIORAL

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

Interventions

Physical Fatigue

Maximal cycling effort for 30s (Wingate modified)

Intervention Type: BEHAVIORAL

Control

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Romain Meeusen

Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Romain Meeusen, Professor

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

Vrije Universiteit Brussel

Brussels, , Belgium

Countries

Belgium

Other Identifiers

143201939780

Identifier Type: -

Identifier Source: org_study_id