Neurophysiological Reserve With Caffeine Manipulation
Neurophysiological Reserve: Peripheral and Central Effects of Caffeine Manipulation
2 other identifiers
interventional
20
1 country
1
Brief Summary
The objective of this study is to verify if there is a neurophysiologic reserve when caffeine and placebo perceived as caffeine are manipulated in closed- and opened-loop exercises. Parameters of excitability level of skeletal muscle and Central Nervous System (CNS), and peripheral metabolism will be measured
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2010
CompletedFirst Posted
Study publicly available on registry
July 22, 2010
CompletedStudy Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedDecember 5, 2014
December 1, 2014
3 months
July 21, 2010
December 4, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neurophysiological reserve evidenced by caffeine
The time to cover a 4-km trial (closed-loop) or the time to exhaustion in an incremental intensity test (opened-loop) can show if the caffeine manipulation affects the performance. In addition, measures of CNS excitability such as EMG during the closed-loop exercise or at the exhaustion point in the opened-loop exercise, and measures such as the amplitude of H reflex, the rate of increase in H reflex/M wave relationship, can indicate if some central or peripheral alteration occurred during the exercises.
Immediately after the administration (around 10 minutes)
Neurophysiological reserve evidenced by caffeine
The time to cover a 4-km trial (closed-loop) or the time to exhaustion in an incremental intensity test (opened-loop) can show if the placebo manipulation affects the performance. In addition, measures of CNS excitability such as EMG during the closed-loop exercise or at the exhaustion point in the opened-loop exercise, and measures such as the amplitude of H reflex, the rate of increase in H reflex/M wave relationship, can indicate if some central or peripheral alteration ocurred during the exercises.
Immediately after the administration (around 10 minutes)
Secondary Outcomes (1)
Neurophysiological reserve evidenced by placebo
Immediately after the administration (around 10 minutes)
Study Arms (1)
Caffeine
EXPERIMENTALInterventions
After ingestion of 6 mg.kg-1 of body mass of caffeine, subjects will perform the one exercise trial.
Eligibility Criteria
You may qualify if:
- trained cyclists
- trained in long distance races
You may not qualify if:
- Maximum oxygen uptake lower than 55 ml/kg/min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of São Paulo
São Paulo, São Paulo, 05508-030, Brazil
Related Publications (1)
Lambert EV, St Clair Gibson A, Noakes TD. Complex systems model of fatigue: integrative homoeostatic control of peripheral physiological systems during exercise in humans. Br J Sports Med. 2005 Jan;39(1):52-62. doi: 10.1136/bjsm.2003.011247.
PMID: 15618343BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Ugrinowitsch, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Post-doctoral
Study Record Dates
First Submitted
July 21, 2010
First Posted
July 22, 2010
Study Start
March 1, 2011
Primary Completion
June 1, 2011
Study Completion
September 1, 2011
Last Updated
December 5, 2014
Record last verified: 2014-12