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The Pacing (Guided Vs Unguided) Strategies Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310334
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
United States Army Research Institute of Environmental Medicine
Information provided by (Responsible Party):
William Rumpler, USDA Beltsville Human Nutrition Research Center

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.

Condition or disease Intervention/treatment Phase
Body Temperature Changes Other: Guided Exercise Session Other: Unguided Exercise Session Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: The Impact of Real-Time Physiological Status Based Pacing Guidance on Physiological Strain for Exercising Humans
Study Start Date : August 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Unguided Pacing Strategy
Each participant will stay in the calorimeter (~24 hrs) on 2 different occasions. During the first visit, the participant will partake in an unguided exercise session.
Other: Guided Exercise Session
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.

Experimental: Guided Pacing Strategy
Each participant will stay in the calorimeter (~24 hrs) on 2 different occasions. During the second visit, the participant will partake in a guided exercise session.
Other: Unguided Exercise Session
Participants will be instructed to complete 5 miles within 60 minutes and finish in as cool (lower body temperature) a state as possible.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310334


Locations
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United States, Maryland
Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705
Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
United States Army Research Institute of Environmental Medicine
Investigators
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Principal Investigator: William V Rumpler, PhD USDA Beltsville Human Nutrition Research Center
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Responsible Party: William Rumpler, Resesarch Physiologist, USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02310334    
Other Study ID Numbers: HS47
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Body Temperature Changes
Signs and Symptoms