- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03515668
Dopamine and Muscle Function in the Heat
The Influence of Dopamine Activity on Neuromuscular Function During Passive Heat Stress
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Increased core temperature (hyperthermia) has been associated with impaired neuromuscular performance, with the majority of research suggesting that the observed fatigue is related to the central nervous system. Small doses of Ritalin has been used to study how changes in dopamine activity affects exercise capacity in the heat. This study found that 20 mg of Ritalin had no effect on exercise capacity in a thermoneutral environment of 18°C. However, when in a hot (30°C) environment, the Ritalin resulted in a 16% improvement in finishing time compared to the placebo trial. Interestingly, the higher output during the Ritalin-hot condition also resulted in higher rates of heat production and a higher (~0.6°C) core temperature, suggesting that dopamine enabled greater voluntary tolerance of hyperthermia. This matches recent work from our own work showing that motivational skills training increased both exercise tolerance and final core temperature, and it is possible that dopamine activity played a role in this improvement.
Ultimately, fatigue is shown in an inability to sustain muscular force. However, the role of dopamine activity on neuromuscular function (e.g., central activation and recruitment of muscle) during hyperthermia is unknown. One study reported that 20 mg of Ritalin did not alter neuromuscular function, but this study was done without thermal stress.
Therefore, our goal is to study the effects of dopamine activity, using Ritalin ingestion, on neuromuscular function over the course of a progressive heating and cooling protocol developed in our lab. We hypothesize that Ritalin will minimize the previously reported progressive impairment in neuromuscular function with hyperthermia (5, 7) compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
St Catharines, Ontario, Canada, L2S 3A1
- Brock University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- High aerobic fitness (>55 mL/kg/min maximal aerobic capacity)
Exclusion Criteria:
- diagnosed cardiovascular, respiratory and/or neuromuscular disease, prescription of Ritalin or any drugs for hyperactivity within the past 1 year, any current prescription medication (except for asthma/allergy inhalers), any contraindications to Ritalin.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Ritalin
20 mg Ritalin, 90 min before testing
|
Single dose for all participants
|
PLACEBO_COMPARATOR: Control
Identical size/taste placebo pill, 90 min before testing
|
Placebo with same appearance/taste
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wrist flexion torque
Time Frame: 2-4 hours after ingestion
|
Maximal voluntary contraction of wrist flexion
|
2-4 hours after ingestion
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Body Temperature Changes
- Heat Stress Disorders
- Hyperthermia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Methylphenidate
Other Study ID Numbers
- 17-123
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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