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Clinical Trials/NCT02310334
NCT02310334
Completed
Not Applicable

The Impact of Real-Time Physiological Status Based Pacing Guidance on Physiological Strain for Exercising Humans

USDA Beltsville Human Nutrition Research Center1 site in 1 country23 target enrollmentAugust 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Body Temperature Changes
Sponsor
USDA Beltsville Human Nutrition Research Center
Enrollment
23
Locations
1
Primary Endpoint
Physiological Strain Index (PSI)
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The objectives of this study are to demonstrate that real time physiological status monitoring and the use of optimization techniques during exercise can have a positive impact on physiological status, and to collect metabolic flexibility profiles of young fit adults during rest and exercise.

Detailed Description

This experiment aims to accomplish two goals: collect additional metabolic flexibility data with young fit adults in response to exercise; and demonstrate that automated pace guidance generated from real-time thermal-work strain monitoring and an optimized pacing policy will allow less stressful completion of a timed (60 minute) treadmill exercise of 5 miles. Each participant will undergo two treatments of first UNGUIDED followed by GUIDED exercise. The two exercise sessions will be conducted as part of a \~24 hour stay in an indirect calorimetry chamber.

Registry
clinicaltrials.gov
Start Date
August 2014
End Date
December 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
USDA Beltsville Human Nutrition Research Center
Responsible Party
Principal Investigator
Principal Investigator

William Rumpler

Resesarch Physiologist

USDA Beltsville Human Nutrition Research Center

Eligibility Criteria

Inclusion Criteria

  • Male and Female
  • Ages 18 to 29 at the beginning of the study
  • Relatively fit can run 2 miles in under 16 minutes

Exclusion Criteria

  • History of Skin Sensitivity to Nickel
  • Hypertension
  • Alcoholism
  • Cannot run 2 miles in less than 16 minutes
  • No regular weekly exercise
  • Difficulty Swallowing Food or Large Pills
  • Diverticulitis
  • Inflammatory Bowel Disease
  • Peptic Ulcer Disease
  • Crohn's Disease

Outcomes

Primary Outcomes

Physiological Strain Index (PSI)

Time Frame: During 2-hour exercise session

The PSI is an index that combines heart rate and core body temperatures with equal weights into an index from 0 to 10+. PSI will be calculated according to Moran et al. (1998) from measures of heart rate and core body temperature.

Secondary Outcomes

  • Continuous Glucose Monitoring(24 hours)
  • Perceived Exertion Scale(During 2-hour exercise session)
  • Self Perception Scales(During 2-hour exercise session)
  • Metabolic Flexibility(24 hours)
  • Feeling Scale(During 2-hour exercise session)
  • Profile of Mood States (POMS) Questionnaire(During 2-hour exercise session)
  • Motivation(During 2-hour exercise session)
  • Thermal Sensation Scale(During 2-hour exercise session)

Study Sites (1)

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