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Completed

NCT Number: NCT02310334

The Pacing (Guided Vs Unguided) Strategies Study

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.

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Key information

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • Diabetes
  • Pregnant
  • Age >29
  • 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
  • Ulcerative Colitis
  • Previous Gastrointestinal Surgery
  • Possible Nuclear Magnetic Resonance Scan
  • Women who have given birth during the previous 12 months
  • Pregnant women or women who plan to become pregnant or become pregnant during the study
  • Lactating women
  • History or presence of kidney disease, liver disease, certain cancers, gastrointestinal, pancreatic, other metabolic diseases, or malabsorption syndromes
  • History of bariatric or certain other surgeries related to weight control
  • Smokers or other tobacco users (for at least 6 months prior to the start of the study)
  • History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
  • Volunteers who have lost 10% of body weight within the last 12 months or who plan to initiate a weight loss program during the next 10 months
  • Unable or unwilling to give informed consent or communicate with study staff.
  • Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
  • Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
  • Blood donation within the previous month

Treatment and study plan

Guided Exercise Session

Other

Participants will be provided a pace based upon their current (estimated) physiological strain index (PSI) - a measure of thermal work strain, the time, and the distance completed already.

Unguided Exercise Session

Other

Participants will be instructed to complete 5 miles within 60 minutes and finish in as cool (lower body temperature) a state as possible.

Primary outcomes

  1. 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

  1. 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.

  2. Continuous Glucose Monitoring

    Time frame: 24 hours

    Continuous glucose monitoring will be used to examine the effects of the exercise regime on blood glucose.

  3. 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.

  4. 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).

  5. 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.

  6. Perceived Exertion Scale

    Time frame: During 2-hour exercise session

    The Borg (1970) rating of perceived exertion (RPE) will be used.

  7. Feeling Scale

    Time frame: During 2-hour exercise session

    The feeling scale will be used as an affective valence measure of exercise.

  8. Motivation

    Time frame: During 2-hour exercise session

    Question will be asked to assess motivation during each exercise session.

Sponsors and collaborators

Lead sponsor

USDA Beltsville Human Nutrition Research Center

Fed

Collaborators

  • United States Army Research Institute of Environmental Medicine

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 8, 2014
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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