Last updated: 11/03/2018 22:45:07

The effects of 2 consecutive days of multiple highintensity exercise bouts on cognitive function, mood and fatigue state in well-trained intermittent sports players.

GSK study ID
204738
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: The effects of 2 consecutive days of multiple highintensity exercise bouts on cognitive function, mood and fatigue state in well-trained intermittent sports players.
Trial description: This study is designed to investigate the effects of high-intensity exercise on parameters of cognitive function in highly-trained intermittent sport athletes. The study will investigate the effect of maximally performing 20 x 20m sprints with ~20 seconds active recovery, on reaction time, memory and executive function. Mood and fatigue states (mental and physical) will also be measured. This bout of exercise and associated cognitive assessments will be performed three times per day (9am/12pm/3pm) over two consecutive days to imitate many modern day sporting tournaments and training routines
Primary purpose:
Not applicable
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Effect of multiple high-intensity exercise bouts in one 24 hour period on simple reaction time (SRT)

Timeframe: 24 hours

Secondary outcomes:

Effect of multiple high-intensity exercise bouts in over two consecutive days on choice reaction time (CRT)

Timeframe: 48 hours

Effect of multiple high-intensity exercise bouts in over two consecutive days on spatial memory

Timeframe: 48 hours

Effect of multiple high-intensity exercise bouts in over two consecutive days on executive function

Timeframe: 48 hours

Effect of multiple high-intensity exercise bouts in over 2 consecutive days on mood

Timeframe: 48 hours

Effect of multiple high-intensity exercise bouts in over 2 consecutive days on perceived fatigue states

Timeframe: 48 hours

Interventions:
  • Other: Control
  • Other: Excercise
    • Enrollment:
    24
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Cognition
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    October 2015 to March 2016
    Type
    Interventional
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    18 - 35 Year
    Accepts healthy volunteers
    yes
    • Subject having an understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
    • Aged between 18 and 35 years inclusive
    • Currently taking any nutritional supplements, polyphenols (or are unwilling to abstain from taking during the study period) or medications (Beta-blockers, NSAID’s, recreational drugs) that could interfere with cognitive function.
    • Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subject having an understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
    • Aged between 18 and 35 years inclusive
    • Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon oral examination
    • Well-trained elite rugby football 7’s and rugby union backs players. Participants should have national playing experience and/or have played above national level 3
    • Willing, able, and likely to comply with all procedures and complete the study, after receiving a full brief, but prior to agreeing to participate in the study.
    Exclusion criteria:
    • Currently taking any nutritional supplements, polyphenols (or are unwilling to abstain from taking during the study period) or medications (Beta-blockers, NSAID’s, recreational drugs) that could interfere with cognitive function.
    • Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit
    • Previous participation in this study
    • Simultaneous participation in another study
    • An employee of the sponsor or the study site or members of their immediate family
    • Have a heart or any other medical condition that may contra-indicate participants from taking part in high intensity or exhaustive physical activity (as assessed by Health & Training Questionnaire).

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2016-01-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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