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临床试验/NCT02310334
NCT02310334已完成不适用

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

USDA Beltsville Human Nutrition Research Center2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2014年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
23
试验地点
2
主要终点
Physiological Strain Index (PSI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
盲法
None

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • History of Skin Sensitivity to Nickel
  • Hypertension
  • Alcoholism
  • 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

结局指标

主要结局

Physiological Strain Index (PSI)

时间窗: 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.

次要结局

  • Continuous Glucose Monitoring(24 hours)
  • Perceived Exertion Scale(During 2-hour exercise session)
  • Self Perception Scales(During 2-hour exercise session)
  • Metabolic Flexibility(24 hours)
  • Feeling Scale(During 2-hour exercise session)
  • Profile of Mood States (POMS) Questionnaire(During 2-hour exercise session)
  • Motivation(During 2-hour exercise session)
  • Thermal Sensation Scale(During 2-hour exercise session)

研究者

发起方
USDA Beltsville Human Nutrition Research Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

William Rumpler

Resesarch Physiologist

USDA Beltsville Human Nutrition Research Center

研究点 (2)

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