跳至主要内容
临床试验/NCT01270529
NCT01270529已完成不适用

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

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Change in Physical Activity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

CKD Stages 1-4

Experimental

干预措施: Increasing Physical activity (Other)

ESRD on Dialysis

Experimental

干预措施: Increasing Physical activity (Other)

Kidney Transplant recipients

Experimental

干预措施: Increasing Physical activity (Other)

结局指标

主要结局

Change in Physical Activity

时间窗: Baseline, 12 weeks

Participants will measure physical activity in the form of daily steps using a pedometer

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验