The Pacing (Guided Vs Unguided) Strategies Study

Not Applicable

Completed

• Conditions: Body Temperature Changes
• Interventions: Other: Guided Exercise Session; Other: Unguided Exercise Session

• Registration Number: NCT02310334
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-03
• Study First Posted: 2014-12-08
• Primary Completion: 2015-04
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Unguided Pacing Strategy	Guided Exercise Session	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.
Guided Pacing Strategy	Unguided Exercise Session	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.

Primary Outcome Measures

Name	Time	Method
Physiological Strain Index (PSI)	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

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

Trial Locations

Locations (1)

Beltsville Human Nutrition Research Center; 🇺🇸 Beltsville, Maryland, United States