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临床试验/NCT04186338
NCT04186338已完成不适用

Daily Physical Activity in Children and Adolescents With Low Lumbar and Sacral Level Myelomeningocele

Marmara University0 个研究点目标入组 20 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
主要终点
Average Activity energy expenditure (AEE)

研究概览

简要总结

Obesity is getting more common and challenging to treat in children and adolescents with myelomeningocele. Therefore, it is becoming more important to determine daily physical activity in these patients. Daily walking performance and average steps per day in patients with low lumbar and sacral level myelomeningocele are shown to not differ from healthy controls. Step counts can not reflect all torsional accelerations associated with daily living activities. Omnidirectional accelerometers provide all types of body movement outputs and give detailed parameters of physical activity level and energy expenditure. There is no data about energy expenditure and physical activity level of the patients with myelomeningocele in daily routine. This study aims to quantify energy expenditure and physical activity of children and adolescents with low lumbar and sacral level myelomeningocele.

详细描述

Children and adolescents with low lumbar and sacral level myelomeningocele, and age-, sex-, and BMI-matched controls were included. Omnidirectional accelerometer monitor (Actical®) was used to assess activity energy expenditure and daily durations spent in sedentary, light activity and moderate to vigorous physical activity (MVPA).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed myelomeningocele with the neurological level between L5 and S3
  • Patients aged between 6 and 16 years
  • Independent ambulatory patients without an assistive device or braces

排除标准

  • Presence of disorders other than myelomeningocele that affect physical activity or exercise (e.g. rheumatic disease, cardiovascular disease)
  • Unable to wear omnidirectional accelerometer monitor (Actical®, Philips Respironics) for five consecutive days

结局指标

主要结局

Average Activity energy expenditure (AEE)

时间窗: After wearing monitors for five consecutive days

Activity energy expenditure (AEE) (kcal/kg/min) refers to thermogenesis from all activities associated with daily living. An average amount of three valid weekdays will be calculated.

次要结局

  • Average physical activity durations(After wearing monitors for five consecutive days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kardelen Gencer Atalay

Principal Investigator

Marmara University

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