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Pedometers to Assess and Increase Physical Activity Among Children With Chronic Kidney Disease

2016年6月22日 更新者:University of California, San Francisco

Hypothesis #1: Most children with CKD stages 2-4, ESRD and kidney transplantation will report participation in physical activity that falls short of recommended levels of physical activity; Children on dialysis will be less active.

Hypothesis #2: Patients will endorse many barriers to physical activity, some of which will be related to their disease or its treatment; those who are less active will endorse more barriers.

Hypothesis #3: Patients will increase their participation in physical activity in response to a pedometer-based 12 week intervention.

Baseline level of physical activity and magnitude of increase in physical activity will be more closely associated with change in physical functioning and performance than stage of kidney disease or type of renal replacement therapy.

Exercise capacity of the child will be measured by the six minute walk test whereby the subject will asked to walk as far as possible in 6 minutes in a straight corridor.

Body fat or body composition will then be measured by Bioelectric Impedance Spectroscopy.

Physical functioning or Health Related Quality of Life will be assessed self reported/ parent proxy reliable and validated questionnaire specifically designed for child with chronic kidney disease called Pediatric Quality of Life Inventory (Peds QL 4.0). Subjects (teens) or parents will also be asked to fill out a questionnaire on barriers to physical activity on their first visit.

Physical activity will be measured in the form of daily steps. The child will wear the pedometer for the first week to assess his/her baseline level of activity. Then the child will continue to wear the pedometer for another 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and motivate the participant.

After 12 weeks of the pedometer-based intervention to increase physical activity, physical performance, body composition and physical functioning (as described above) will be measured once again to assess the effect of increased physical activity on a second visit.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

44

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • San Francisco、California、美国、94122
        • UCSF

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

6年 至 20年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Pediatric patients, male and female, aged 6-20 years.
  • Chronic kidney disease stages 2-4 and ESRD on peritoneal dialysis or hemodialysis and kidney transplantation.
  • Patients who can follow simple commands.
  • English and Spanish speaking only.

Exclusion Criteria:

  • Patients hospitalized in the past 1 month.
  • Patients hospitalized in the past I month for infection.
  • Patients hospitalized in the past 1 month post peritoneal or hemodialysis catheter placement for the first time.
  • 1 month after starting renal replacement therapy for the first time.
  • 3 months post kidney transplantation.
  • In the opinion of the investigator too ill to participate.
  • Unwilling to participate.
  • Language barrier.
  • Patient with any signs of active infection, shortness of breath, trauma or injury to the legs or feet or those undergoing cardiac evaluation.
  • Patients unable to verbalize discomfort or developmental delay will not be included.
  • Patients with respiratory distress or on oxygen will be excluded.
  • Parents or subjects unable to afford transportation for the 2 scheduled visits will also be excluded.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:CKD Stages 1-4
The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
实验性的:ESRD on Dialysis
The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
实验性的:Kidney Transplant recipients
The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Physical Activity
大体时间:Baseline, 12 weeks
Participants will measure physical activity in the form of daily steps using a pedometer
Baseline, 12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年7月1日

初级完成 (实际的)

2012年6月1日

研究完成 (实际的)

2014年3月1日

研究注册日期

首次提交

2011年1月3日

首先提交符合 QC 标准的

2011年1月4日

首次发布 (估计)

2011年1月5日

研究记录更新

最后更新发布 (估计)

2016年8月4日

上次提交的符合 QC 标准的更新

2016年6月22日

最后验证

2016年6月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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