The Pacing (Guided Vs Unguided) Strategies Study

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

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.

Study Overview

• Status: Completed
• Conditions: Body Temperature Changes
• Intervention / Treatment: Other: Guided Exercise Session; Other: Unguided Exercise Session

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: NON_RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center
• Collaborators: United States Army Research Institute of Environmental Medicine
• Investigators: Principal Investigator: William V Rumpler, PhD, USDA Beltsville Human Nutrition Research Center

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (ACTUAL): April 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: December 3, 2014
• First Posted (ESTIMATE): December 8, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): February 24, 2016
• Last Update Submitted That Met QC Criteria: February 23, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes
• Other Study ID Numbers: HS47