The Pacing (Guided Vs Unguided) Strategies Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Body Temperature Changes

Intervention / Treatment
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* Other: Guided Exercise Session
* Other: Unguided Exercise Session


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unguided Pacing Strategy<br>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<br>* 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.<br>|
| Experimental: Guided Pacing Strategy<br>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<br>* Participants will be instructed to complete 5 miles within 60 minutes and finish in as cool (lower body temperature) a state as possible.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological Strain Index (PSI) | 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. | During 2-hour exercise session | 

Secondary Outcome Measures

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