Use of Pedometers to Measure and Increase Walking Among Patients With ESRD (PED)
2019年9月10日 更新者:University of California, San Francisco
Randomized controlled trial using pedometers to increase physical activity among patients on dialysis.
研究概览
研究类型
介入性
注册 (实际的)
60
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、94114
- University of California San Francisco
-
-
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
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- on hemodialysis for ≥ 3 months
- able to walk
- able to give informed consent and willing to participate
Exclusion Criteria:
- unable to walk
- unable to understand directions or give informed consent
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:随机化
- 介入模型:并行分配
- 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:pedometer
Patients will be given pedometers and instructions to increase physical activity based on pedometer output
|
pedometer-based physical activity recommendations
|
无干预:usual care
No intervention
|
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 |
---|---|---|
Physical Activity
大体时间:Baseline and 12 weeks
|
change in steps per day from pedometer
|
Baseline and 12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Physical Performance
大体时间:Baseline and 12 weeks
|
change in score on the Short Physical Performance Battery (0-12), higher scores indicate greater physical performance
|
Baseline and 12 weeks
|
Self-reported Physical Functioning
大体时间:Baseline and 12 weeks
|
Change in score on the Physical Function scale of the Short-Form 36 Health Survey (scale from 0-100, higher numbers indicate better physical functioning)
|
Baseline and 12 weeks
|
Change in Activities of Daily Living Score
大体时间:Baseline and 12 weeks
|
Barthel's Index of Daily Activities (Index range 0-20, higher scores indicate greater functional independence)
|
Baseline and 12 weeks
|
Change in Symptom Burden on the Dialysis Symptoms Index
大体时间:Baseline and 12 weeks
|
Dialysis symptom index (symptom burden ranges from 0 - 29 symptoms experienced)
|
Baseline and 12 weeks
|
Change in Total Body Muscle Mass (Adjusted by Height Squared)
大体时间:Baseline and 12 weeks
|
(TBMM calculated from measurements of intracellular water from bioimpedance spectrometry)
|
Baseline and 12 weeks
|
Change in Endothelial Function
大体时间:12 weeks
|
Reactive hyperemia index (RHI) using peripheral arterial tonometry.
RHI is a non-invasive measure of endothelial function, measured using the EndoPAT 2000 (Itamar Medical).
The pulse amplitude in the middle fingers of both hands was recorded for five minutes.
A blood pressure cuff was then inflated in one arm (which did not have a vascular access in place) to at least 60 mmHg above systolic blood pressure to achieve full occlusion (minimum 200 mmHg, maximum 300 mmHg).
After occlusion for 5 minutes, the cuff was deflated, and the device recorded changes in pulse amplitude for an additional 5 minutes and calculated RHI as the ratio of the post to pre occlusion amplitude of the occluded arm relative to the post to pre occlusion amplitude of the control arm, corrected for baseline vascular tone.
|
12 weeks
|
Change in the Short From 36 Vitality Scale
大体时间:Baseline and 12 weeks
|
Short Form 36 Vitality Scale (0-100, greater values indicate increased levels of energy/decreased levels of fatigue)
|
Baseline and 12 weeks
|
Change in SDNN (ms)
大体时间:12 weeks
|
Standard deviation of N-N intervals as recorded on electrocardiography waveform (ms)
|
12 weeks
|
Change in Symptom Severity on Dialysis Symptoms Index
大体时间:Baseline and 12 weeks
|
Symptoms range from score of 0 (Not at all bothersome) to 5 (Very Bothersome) over 29 symptoms.
Score ranges from 0 - 145
|
Baseline and 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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Sheshadri A, Kittiskulnam P, Delgado C, Sudore RL, Lai JC, Johansen KL. Association of Cognitive Function Screening Results with Adherence and Performance in a Pedometer-Based Intervention. Am J Nephrol. 2021;52(5):420-428. doi: 10.1159/000516130. Epub 2021 May 12.
- Sheshadri A, Kittiskulnam P, Delgado C, Sudore R, Lai JC, Johansen KL. Association of motivations and barriers with participation and performance in a pedometer-based intervention. Nephrol Dial Transplant. 2020 Aug 1;35(8):1405-1411. doi: 10.1093/ndt/gfaa047.
- Sheshadri A, Kittiskulnam P, Lai JC, Johansen KL. Effect of a pedometer-based walking intervention on body composition in patients with ESRD: a randomized controlled trial. BMC Nephrol. 2020 Mar 16;21(1):100. doi: 10.1186/s12882-020-01753-5.
- Sheshadri A, Kittiskulnam P, Lazar AA, Johansen KL. A Walking Intervention to Increase Weekly Steps in Dialysis Patients: A Pilot Randomized Controlled Trial. Am J Kidney Dis. 2020 Apr;75(4):488-496. doi: 10.1053/j.ajkd.2019.07.026. Epub 2019 Nov 1.
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 (实际的)
2015年12月1日
初级完成 (实际的)
2018年6月1日
研究完成 (实际的)
2018年6月1日
研究注册日期
首次提交
2015年12月1日
首先提交符合 QC 标准的
2015年12月2日
首次发布 (估计)
2015年12月7日
研究记录更新
最后更新发布 (实际的)
2019年10月2日
上次提交的符合 QC 标准的更新
2019年9月10日
最后验证
2019年9月1日
更多信息
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.