The Pacing (Guided Vs Unguided) Strategies Study

NCT02310334 | Completed

• 1 other identifier: HS47
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Body Temperature Changes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Metabolic Flexibility

  24 hours

• Continuous Glucose Monitoring

  24 hours

• Self Perception Scales

  During 2-hour exercise session

• Profile of Mood States (POMS) Questionnaire

  During 2-hour exercise session

• Thermal Sensation Scale

  During 2-hour exercise session

Study Arms (2)

Unguided Pacing Strategy

EXPERIMENTAL

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

Guided Pacing Strategy

EXPERIMENTAL

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

Interventions

Guided Exercise Session OTHER

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 Pacing Strategy

Unguided Exercise Session OTHER

Participants will be instructed to complete 5 miles within 60 minutes and finish in as cool (lower body temperature) a state as possible.

Guided Pacing Strategy

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and Female
• Ages 18 to 29 at the beginning of the study
• Relatively fit can run 2 miles in under 16 minutes

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead
• United States Army Research Institute of Environmental Medicine: collaborator

Study Sites (1)

Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

MeSH Terms

Conditions

Body Temperature Changes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William V Rumpler, PhD

  USDA Beltsville Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resesarch Physiologist

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 8, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

US (1)