The Pacing (Guided Vs Unguided) Strategies Study

Body Temperature Changes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02310334
• Other study ID #: HS47
• Status: Completed
• Phase: N/A
• First received: December 1, 2014
• Last updated: February 23, 2016
• Start date: August 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 29 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Body Temperature Changes

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center	United States Army Research Institute of Environmental Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Metabolic Flexibility	O2 utilization and CO2 production will be analyzed during each calorimeter stay and used to measure metabolic rate indirectly.	24 hours	No
Secondary	Continuous Glucose Monitoring	Continuous glucose monitoring will be used to examine the effects of the exercise regime on blood glucose.	24 hours	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Perceived Exertion Scale	The Borg (1970) rating of perceived exertion (RPE) will be used.	During 2-hour exercise session	No
Secondary	Feeling Scale	The feeling scale will be used as an affective valence measure of exercise.	During 2-hour exercise session	No
Secondary	Motivation	Question will be asked to assess motivation during each exercise session.	During 2-hour exercise session	No