The Pacing (Guided Vs Unguided) Strategies Study
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|ClinicalTrials.gov Identifier: NCT02310334|
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : February 24, 2016
|Condition or disease||Intervention/treatment||Phase|
|Body Temperature Changes||Other: Guided Exercise Session Other: Unguided Exercise Session||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|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|
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.
- 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.
- 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.
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
|United States, Maryland|
|Beltsville Human Nutrition Research Center|
|Beltsville, Maryland, United States, 20705|
|Principal Investigator:||William V Rumpler, PhD||USDA Beltsville Human Nutrition Research Center|