Validation of MotionPODTM a Device for Measuring Physical Activity, in Free-living Conditions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Daily physical activity energy expenditure (PAEE) MOTIONPODTM prediction
研究概览
简要总结
In this study, the investigators propose to assess the validity in measuring physical activity (PA) of a new PA monitor system the MOTIONPODTM, that coupled a hip-worn multi-sensor device (associating a tri-axial accelerometer, a magnetometer and a gyroscope) with an automatic activity/posture recognition algorithm and an activity-specific multilinear prediction model. The MOTIONPODTM performances in predicting mean daily PA energy expenditure (PAEE) will be calculated against the reference PAEE gold standard measure, using the doubly labeled water method (DLW). The MOTIONPODTM performances in predicting PAEE and PA patterns will be compared to those of two existing activity or movement monitors: the triaxial accelerometer ActigraphGT3X+TM and a device combining cardiofrequencemetry with accelerometry, the ActiheartTM. This latter has demonstrated fair performances but at the cost of a calibration of the heart-rate/EE relationship that limits its use in large population samples. Briefly, this open study will include 120 subjects, aged 18 to 75 years of both gender and with broad range of body mass index and physical activity level. The subjects will carry a MOTIONPODTM, an ActigraphGT3X+TM, an ActiheartTM and a GPS for a total of 14 days in everyday life conditions and complete a physical activity diary. In half of the subjects, PA will be evaluated on a period of 14 days, with standard PAEE measured by DLW. The other 60 subjects will be studied twice, one month apart, to test the reproducibility of the measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects
- •Age : 18 to 75 years
- •Patients or healthy volunteers
- •40 obese subjects (BMI ≥ 30 kg/m2), 40 non-obese (BMI <30 kg/m2) and active (PA level evaluated by the RPAQ questionnaire) subjects, 40 non-obese and sedentary subjects
- •Absence of cardiac rate disorders
排除标准
- •Subjects with acute disorders: cardiovascular or neoplastic, severe infection during 3 previous months
- •Subjects with a pathology restricting the walking distance (confinement, distance <200 meters)
- •Subjects with implants (Pacemaker, cardiac implant or another active implant)
- •Claustrophobic subjects (for subjects participating to "doubly labelled water" protocol)
- •Drug use that could affect energy expenditure
研究组 & 干预措施
MotionPod Validation
Medical device validation
干预措施: MOTIONPODTM device validation (Device)
结局指标
主要结局
Daily physical activity energy expenditure (PAEE) MOTIONPODTM prediction
时间窗: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
MotionPodTM predictions will be calculated with the newly developed algorithms to evaluate the concordance between the physical activity energy expenditure (PAEE) estimated by the MOTIONPODTM and that of 2 physical activity monitors: the Actigraph GT3X+TM and the ActiheartTM. The estimation of PAEE by MotionPodTM will be compared with the measure of PAEE by DLW (gold standard measure, primary outcome 2/), with the measure of PAEE by Actiheart TM (primary outcome 3/), and with the measure of PAEE by ActigraphGT3X+ TM (primary outcome 4/).
Daily physical activity energy expenditure (PAEE) using DLW (gold standard measure) (modality A)
时间窗: PAEE measurement will be measured over the 14-day study-period (Modality A)
Daily Total Energy Expenditure (TEE) and PAEE standards will be measured with the DLW reference method. Briefly Resting metabolic Rate (RMR) will be measured via indirect calorimetry using a ventilated open-hood metabolic cart after a 12h-overnight fast. TEE will be determined using a 14-day multipoint DLW protocol. After providing a baseline urine sample, subjects will ingest a premixed dose of H218O (10% enriched) and 2H2O (99.85% enriched) DLW. Equilibration will be assessed in urine samples collected at 4h and 5h post dose. Subsequent urine samples will be collected every two days of the 14 days of the protocol. 2H2 and 18O isotopic enrichment will be analyzed in quadruplicate by pyrolysis on an elemental analyzer (Flash HT; ThermoFisher) interfaced with an IRMS (Delta V, ThermoFisher).
Daily physical activity energy expenditure (PAEE) Actiheart TM estimates (modalities A & B)
时间窗: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
ActiheartTM PAEE predictions will be calculated using the Actiheart software.
Daily physical activity energy expenditure (PAEE) ActigraphGT3X+ TM estimates (modalities A & B)
时间窗: PAEE measurement will be measured over the 14-day study-period (Modality A) or the two 8-day periods (Modality B)
ActigraphGT3X+TM PAEE predictions will be calculated using the ActigraphGT3X+ TM software.
次要结局
- Identification and classification of activity/posture patterns by the MOTIONPODTM device (assessed by confusion matrices)(PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B))
- Identification and classification of activities/postures patterns collected in the activity diary(PAEE activity patterns will be evaluated over the 14-day study-period (Modality A) or over the two 8-day periods (Modality B))
- (BMI < or > 30 kg/m2).(Baseline (at inclusion))