Clinical Trial: The Pacing (Guided Vs Unguided) Strategies Study

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: USDA Beltsville Human Nutrition Research Center

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Metabolic Flexibility [ Time Frame: 24 hours ]
    O2 utilization and CO2 production will be analyzed during each calorimeter stay and used to measure metabolic rate indirectly.
  • Continuous Glucose Monitoring [ Time Frame: 24 hours ]
    Continuous glucose monitoring will be used to examine the effects of the exercise regime on blood glucose.
  • Self Perception Scales [ Time Frame: During 2-hour exercise session ]
    Self perception scales will be used that measure mood state, perceived exertion, thermal sensation, physical stresses and motivation.
  • Profile of Mood States (POMS) Questionnaire [ Time Frame: During 2-hour exercise session ]
    The POMS is an inventory of subjective mood states (McNair, Lorr and Droppleman, 1992).
  • Thermal Sensation Scale [ Time Frame: During 2-hour exercise session ]
    Two thermal sensation scales (original and modified) will be used to assess the thermal sensation of volunteers.
  • Perceived Exertion Scale [ Time Frame: During 2-hour exercise session ]
    The Borg (1970) rating of perceived exertion (RPE) will be used.
  • Feeling Scale [ Time Frame: During 2-hour exercise session ]
    The feeling scale will be used as an affective valence measure of exercise.
  • Motivation [ Time Frame: During 2-hour exercise session ]
    Question will be asked to assess motivation during each exercise session.


Original Secondary Outcome: Same as current

Information By: USDA Beltsville Human Nutrition Research Center

Dates:
Date Received: December 1, 2014
Date Started: August 2014
Date Completion:
Last Updated: February 23, 2016
Last Verified: February 2016