A pilot study to assess physical activity and heart ratevariability in Indian Children using the LifeInsightâ„¢BioTelemetry Platform
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- 1. Movement/physical activity during structured exercise
研究概览
简要总结
Objective quantification of physical activity is becoming anincreasingly important measure in health research. For example, the accuratemeasurement of daily movement is critical to understanding the relativecontribution of physical activity to weight management and metabolic health. Theaim of this study is to investigate the validity and repeatability of thistechnology for assessing overall daily activity and activity during controlledexercise, as well as HRV in Indian children aged from 9 to 11. This study willbe conducted in India and results may be used in subsequent interventionaltrials, for which resulting communications may be used about children’s dailyphysical activity levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 9.00 Year(s) 至 11.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Demonstrates understanding of the study and willingness to participate.
- •Good general and mental health and no clinically significant and relevant abnormalities in medical history or upon physical examination.
- •Absence of any condition that would impact on the participant’s safety or wellbeing 4.Participant and participant’s parents/LAR understand and are willing, able and likely to comply with all study procedures and restrictions.
- •Able to read and comprehend one of the languages used for study visits and assessments.
排除标准
- •1.A child cared for by foster parents or living in a care home or institution.
- •2.Concurrent Medication/ Medical History Use of concomitant medication that, in the opinion of the Principal Investigator, might interfere with the outcome of the study.
- •3.Allergy/ Intolerance Known or suspected intolerance or hypersensitivity to the study materials.
- •4.Participation in another clinical study within 30 days of the screening visit.
- •5.Previous participation in this study.
- •7.An employee of the sponsor or the study site or members of their immediate family/ OR Sibling of child already part of this study.
- •8.Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study.
结局指标
主要结局
1. Movement/physical activity during structured exercise
时间窗: 1. Up to 72 hours | 2. Up to 72 hours
2. Heart Rate Variability (HRV) during structured exercise
时间窗: 1. Up to 72 hours | 2. Up to 72 hours
次要结局
- 1. Movement/physical activity and heart rate variability during spontaneous daily physical activity, including sleep(2. Heart rate variability during spontaneous daily physical activity, including sleep)