Effects of Dehydration on Neuromuscular Performance and Sympathetic Control of Cardiovascular Function
1 other identifier
interventional
43
0 countries
N/A
Brief Summary
The mechanism(s) by which dehydration (both intra- and extracellular) impairs performance are still poorly described. A loss of volume results in increased occurrence of orthostatic intolerance, including dizziness, fatigue, headaches and related symptoms with upright posture. Any of these symptoms can contribute to decreased performance in maneuvers performed in the upright posture, which includes many military tasks. Thus, loss of volume challenges the cardiovascular and blood pressure responses to systemic whole body endurance exercise, while osmolality is the stimulus for intracellular dehydration that may impair local muscle force production by impairing contractile function, neural signaling, or both. In this study, we will compare how both types of dehydration affect MSNA and CAC. The results of this study will provide mechanistic insight for how dehydration (intra- or extracellular) impairs systemic whole body and local small muscle performance in vivo. This Basic Science study seeks to understand how volume and osmolality impact MSNA and CAC as a basis for improving potential countermeasures, such as a more optimally formulated rehydration beverage. Therefore, this study directly complements Task Area T10 (Hot Weather Operations and Hydration: Injury and Performance Optimization) and impacts virtually all 14 Military Operational Medicine Research Program Drivers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2014
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2016
CompletedFirst Submitted
Initial submission to the registry
August 23, 2017
CompletedFirst Posted
Study publicly available on registry
August 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 22, 2020
April 1, 2020
2.1 years
August 23, 2017
April 20, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Water and electrolyte retention
Mass balance measures of total body water and electrolytes
180 minutes
Secondary Outcomes (1)
Body water compartment changes
180 minutes
Study Arms (2)
Exercise heat STress (EHS)
EXPERIMENTALEHS - dehydration produced by sweating and fluid restriction; primary loss of body water accompanied by small loss of electrolytes (hypertonicity). Interventions include rehydration with Gatorade or Enterade oral rehydration therapies.
Lasix (LAS)
EXPERIMENTALLAS - dehydration produced by Lasix (diuretic, 80 mg oral dose) administration to produce losses of body water accompanied by large losses of electrolytes (isotoncity). Interventions include rehydration with Gatorade or Enterade oral rehydration therapies.
Interventions
Commercially available oral rehydration therapies
Eligibility Criteria
You may qualify if:
- Male or female, age 18-45
- In good health as determined by OMSO General Medical Clearance
- Passed his/her most recent Army Physical Fitness Test (APFT) (military volunteers only) or exercise at least 2 times per week (civilian volunteers)
- Ability to comprehend and willingness to sign informed consent
You may not qualify if:
- Females who are pregnant or planning to become pregnant during the study
- Taking prescription or over the counter medication, other than a contraceptive (unless approved by OMSO and PI)
- Physical problems/injuries associated with walking or cycling
- Allergy to sulfa drugs (Lasix™ or sulfonamide antibiotics such as Septra™)
- Allergy to skin adhesive
- Hemoglobinopathy (sickle cell trait)
- Heart, lung, kidney, muscle, or nerve disorder(s)
- History of heat or orthostatic intolerance
- Diagnosed and/or treated for fluid/electrolyte imbalance within the last 30 days
- Presence of metal implants/electronic medical devices in lower extremities
- Current or previous (within the past 5 years) diagnosis of any autonomic disorder, including idiopathic orthostatic intolerance, orthostatic hypotension, postural tachycardia syndrome (POTS), or neurocardiogenic syncope (MSNA group only)
- Tobacco/nicotine use (MSNA group only)
- Significant muscle, joint, or bone injury affecting the legs within the last 6 months (CAC group only)
- Difficulty swallowing large pills
- History of obstructive disease of the gastrointestinal tract including (but not limited to) diverticulosis, diverticulitis and inflammatory bowel disease, peptic ulcer disease, Crohn's disease, ulcerative colitis; or previous gastrointestinal surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2017
First Posted
August 28, 2017
Study Start
October 31, 2014
Primary Completion
December 8, 2016
Study Completion
December 1, 2017
Last Updated
April 22, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share