The Pacing (Guided Vs Unguided) Strategies Study

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Body Temperature Changes

Treatments: Other: Unguided Exercise Session; Other: Guided Exercise Session

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02310334

HS47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

23 participants in 2 patient groups

Unguided Pacing Strategy

Experimental group

Description:

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.

Treatment:

Other: Guided Exercise Session

Guided Pacing Strategy

Experimental group

Description:

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.

Treatment:

Other: Unguided Exercise Session