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The Pacing (Guided Vs Unguided) Strategies Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02310334
Enrollment
23
Registered
2014-12-08
Start date
2014-08-31
Completion date
2015-12-31
Last updated
2016-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Temperature Changes

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.

Interventions

OTHERGuided 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.

OTHERUnguided 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.

Sponsors

United States Army Research Institute of Environmental Medicine
CollaboratorFED
USDA Beltsville Human Nutrition Research Center
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Physiological Strain Index (PSI)During 2-hour exercise sessionThe 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

MeasureTime frameDescription
Continuous Glucose Monitoring24 hoursContinuous glucose monitoring will be used to examine the effects of the exercise regime on blood glucose.
Self Perception ScalesDuring 2-hour exercise sessionSelf perception scales will be used that measure mood state, perceived exertion, thermal sensation, physical stresses and motivation.
Profile of Mood States (POMS) QuestionnaireDuring 2-hour exercise sessionThe POMS is an inventory of subjective mood states (McNair, Lorr and Droppleman, 1992).
Metabolic Flexibility24 hoursO2 utilization and CO2 production will be analyzed during each calorimeter stay and used to measure metabolic rate indirectly.
Perceived Exertion ScaleDuring 2-hour exercise sessionThe Borg (1970) rating of perceived exertion (RPE) will be used.
Feeling ScaleDuring 2-hour exercise sessionThe feeling scale will be used as an affective valence measure of exercise.
MotivationDuring 2-hour exercise sessionQuestion will be asked to assess motivation during each exercise session.
Thermal Sensation ScaleDuring 2-hour exercise sessionTwo thermal sensation scales (original and modified) will be used to assess the thermal sensation of volunteers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026