Technology to Improve Assessment of Physical Activity

描述(申请人提供)：这项研究的目标是检查LifeChek KAL-X传感器在不同模式和强度的体力活动中评估能量消耗的有效性和可靠性。我们还将检查环境条件或服装变化是否会影响KAL-X传感器的精度或性能。此外，我们还将研究KAL-X传感器和自由生活期间自我报告的体力活动之间的相关性。这也将使我们能够检查参与者是否愿意长时间佩戴这种设备，以及传感器在自由生活条件下的完整性。这项申请是对美国国立卫生研究院最近宣布的一项计划(PAR-03-009)的回应。 拟议的研究将包括三个阶段；在第一阶段，我们将比较KAL-X传感器的能量消耗与能量消耗的标准测量(间接量热法)。这将要求受试者进行各种活动，包括以下活动：跑步机步行、自行车测功机、手臂测功机、阻力练习和模拟生活方式活动。每一次活动将在单独的一天进行，使用LifeChek KAL-X传感器估计能量消耗，能量消耗的标准测量将是间接量热法。为了评估体重和体型的变化是否会影响KAL-X传感器的准确性，我们将从三个体重指数类别(20-24.9 kg/m2，25-29.9 kg/m2，30-35 kg/m2)招募相同数量的男性和女性。基于力量分析，48名受试者(每个体重指数类别16人)将被招募参与这项研究。 在第二阶段，受试者将进行大约60分钟的户外活动。同样，能源消耗将使用LifeChek KAL-X传感器进行估计，能源消耗的标准测量将是间接量热法。我们还将监测环境条件(温度、湿度和云量)，以评估这些因素是否会影响KAL-X传感器的准确性。 在第三阶段，受试者将在自由生活条件下佩戴KAL-X传感器一周。这将使我们能够比较KAL-X传感器的能源消耗与使用问卷的自我报告估计的能源消耗。此外，我们将能够检查参与者是否愿意在自由生活条件下佩戴该设备和KAL-X传感器的完整性。 我们假设，在KAL-X传感器和间接量热法之间的验证研究中，能量消耗的测量结果之间没有显著差异。此外，我们假设服装和环境条件不会影响KAL-X传感器的准确性或可靠性。此外，我们假设受试者将愿意佩戴KAL-X传感器，并且传感器在自由生活条件下将是可靠的。KAL-X传感器是一项创新技术，可能会彻底改变能量消耗的评估，并可能对改善临床计划的结果产生影响。

DESCRIPTION (provided by applicant): The goal of this study is to examine the validity and reliability of the LifeChek KAL-X Sensor to assess energy expenditure during varying modes and intensities of physical activity. We will also examine whether environmental conditions or variations in clothing impact the accuracy or performance of the KAL-X Sensor. In addition, we will examine the correlation between the KAL-X Sensor and self-reported physical activity across a period of free-living. This will also permit us to examine if participants are willing to wear this device for an extended period of time and the integrity of the sensor under free-living conditions. This application is in response to a recent program announcement by the NIH (PAR-03-009). The proposed study will involve three phases; in Phase 1 we will compare energy expenditure from the KAL-X Sensor to a criterion measure of energy expenditure (indirect calorimetry). This will involve the subjects performing a variety of activities including the following: treadmill walking, cycle ergometry, armcrank ergometry, resistance exercise, and a simulation of lifestyle activity. Each activity session will be performed on a separate day with energy expenditure estimated using the LifeChek KAL-X Sensor and the criterion measure of energy expenditure will be indirect calorimetry. To assess whether variations in bodyweight and body size impact the accuracy of the KAL-X Sensor, we will recruit equal numbers of men and women from three body mass index categories (20-24.9 kg/m 2, 25-29.9 kg/m 2, 30-35 kg/m2). Based on a power analysis, 48 subjects (16 in each body mass index category) will be recruited to participate in this study. In Phase 2 subjects will perform an outdoor activity for a period of approximately 60 minutes. Again, energy expenditure will be estimated using the LifeChek KAL-X Sensor and the criterion measure of energy expenditure will be indirect calorimetry. We will also monitor environmental conditions (temperature, humidity, and cloud cover) to assess whether these factors impact the accuracy of the KAL-X Sensor. In Phase 3 subjects will wear the KAL-X Sensor for a one-week period under free-living conditions. This will allow us to compare energy expenditure from the KAL-X Sensor with energy expenditure estimated from self-report using a questionnaire. Moreover, we will be able to examine if participants are willing to wear this device and the integrity of the KAL-X Sensor under free-living conditions. We hypothesize that there will be no significant difference between the measurements of energy expenditure in the validation study between the KAL-X Sensor and indirect calorimetry. In addition, we hypothesize that clothing and environmental conditions will not affect the accuracy or reliability of the KAL-X Sensor. Moreover, we hypothesize that subjects will be willing to wear the KAL-X Sensor and that the sensor will be reliable under free-living conditions. The KAL-X Sensor is an innovative technology that may revolutionize the assessment of energy expenditure and may have implications for improving outcomes in clinical programs.