Effects of Home-based or Center-based Aerobic Exercise in Patients With Chronic Kidney Disease (HBCKD)
2015年3月24日 更新者：Lilian Cuppari、Federal University of São Paulo
Effects of Home-based or Center-based Aerobic Exercise on Physical Function, Nutritional Status Ans Cardiopulmonary Parameters in Patients With Chronic Kidney Disease
Patients will be randomly assigned to perform the training program in center or home-based . The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine. All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes). The program will consist of 24 weeks with three sessions per week on alternate days. The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks. The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways. The intensity control was done by means of the heart rate value obtained at ventilatory threshold.
Both groups receive the same intervention. However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher. The other group will exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.
It will also constituted a control group remain without performing any activity during the study period. After 24 weeks patients receive the same advice the team conducting the training at home.
研究概览
研究类型
介入性
注册 (实际的)
45
阶段
- 不适用
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
30年 至 65年 (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:
- Sedentary individuals with chronic kidney disease stages 3 or 4 disease;
- Both genders;
- Age between 30 and 65 years;
- Overweight (BMI> 25 kg/m2);
- With a negative stress test.
Exclusion Criteria:
- Patients with chronic obstructive pulmonary disease,
- class IV heart failure,
- myocardial infarction within the last 6 months,
- decompensated hypertension (systolic blood pressure> 180 mmHg or diastolic> 110 mmHg in the last 6 months),
- uncontrolled cardiac arrhythmia,
- decompensated diabetes mellitus (glycated hemoglobin> 8.0%),
- unstable angina,
- infectious processes in the last 3 weeks;
- begin use of erythropoietin or with hemoglobin <11g/L.
- use of beta-blocker medication
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：支持治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：sedentary control
|
|
|
实验性的：Home-based aerobic exercise
The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine.
All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes).
The program will consist of 24 weeks with three sessions per week on alternate days.
The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks.
The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways.
The intensity control was done by means of the heart rate value obtained at ventilatory threshold.
The home-based exercise group exercise at home with telephone follow-up weekly and once a month will be held at the training center under the supervision of a physical education teacher.
|
|
|
有源比较器：Center-based aerobic exercise
The training program will be conducted in accordance with the recommendations of the American College of Sports Medicine.
All training sessions will be preceded by stretching of large muscle groups and heating (5 minutes) and at the end by cool down and stretching (5 minutes).
The program will consist of 24 weeks with three sessions per week on alternate days.
The aerobic training will be continuous, with an increment of 10 minutes in duration every 4 weeks.
The intensity will be prescribed according to ventilatory threshold, characterized by the highest intensity of physical exertion fully maintained by aerobic energy pathways.
The intensity control was done by means of the heart rate value obtained at ventilatory threshold.
However, a group exercise held in the center on a treadmill with the direct supervision of a physical education teacher.
|
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 |
|---|---|---|
|
Cardiopulmonary capacity
大体时间：24 weeks
|
The test began with a fixed inclination of 1%.
The initial velocity was 2 km/h during the first three minutes with increments of 0.5km/h every minute until the patient reaches physical exhaustion.
The ventilatory variables were measured using a gas analyzer.
The highest oxygen uptake obtained during the last stage reached was considered the peak oxygen uptake.
The ventilatory threshold was determined as the stage preceding the first occurrence of the exponential increase in ventilation, increase in the ventilatory equivalent for oxygen and increase in expired fraction of oxygen.
The respiratory compensation point was determined as the stage preceding the second occurrence of the exponential increase in ventilation, increase in the ventilatory equivalent for carbon dioxide and decrease in end-tidal carbon dioxide.
Data were analyzed by the average of 20 seconds.
|
24 weeks
|
|
Functional capacity (walk, sit-stand, arm curl, sit-reach, back scratch, timed up and go)
大体时间：24 weeks
|
Functional capacity was assessed using a variety of objective measures.
These included six-minute walk test (maximal distance walked along an internal corridor during six minutes), two-minute step test (maximal number of steps achieved in stationary walking during two minutes, used to quantifying the aerobic power), sit-to-stand test (maximal sit to stand cycles achieved in 30 seconds, used to quantifying the muscular endurance of the legs), arm curl test (maximal number of arm curl cycles in 30 seconds, used to quantifying the muscular endurance of the arms), sit and reach test (maximal distance achieved in the Wells bench, used to quantifying the general flexibility), back scratch test (maximum amplitude of the arms used to quantifying the arms flexibility) and time up and go test (shorter time to rise from a chair, walk three meters and sit back, used to quantifying the functional mobility).
|
24 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of life
大体时间：24 weeks
|
The Short-Form Health Survey (SF-36) questionnaire was applied to assess the quality of life.
The scores for each domain range from 0 to 100%.
The higher scores define a better quality of life.
The questionnaire was applied individually in a clear and quiet room with the patient rested.
|
24 weeks
|
|
sleep quality (PSQI)
大体时间：24 weeks
|
The PSQI assesses the quality of sleep for the last month of the interview.
The questionnaire has 19 questions that comprise seven assessment components: quality of sleep, latency, duration, efficiency, nocturnal sleep disturbances, use of sleep medication and daytime sleepiness.
Each component receives a score from 0 to 3, in a way that the final score can range between 0 and 21.
The higher the score, the worse the quality of sleep, and scores higher than five indicate sleep disturbances.
|
24 weeks
|
|
blood pressure
大体时间：24 weeks
|
Blood pressure and resting heart rate were measured before the cardiopulmonary exercise test.
|
24 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。
调查人员
- 首席研究员：Lilian Cuppari, PhD、Federal University of São Paulo
- 首席研究员：Danilo T Aoike, MSc、Federal University of São Paulo
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
- Conley MM, McFarlane CM, Johnson DW, Kelly JT, Campbell KL, MacLaughlin HL. Interventions for weight loss in people with chronic kidney disease who are overweight or obese. Cochrane Database Syst Rev. 2021 Mar 30;3(3):CD013119. doi: 10.1002/14651858.CD013119.pub2.
- Gomes TS, Aoike DT, Baria F, Graciolli FG, Moyses RMA, Cuppari L. Effect of Aerobic Exercise on Markers of Bone Metabolism of Overweight and Obese Patients With Chronic Kidney Disease. J Ren Nutr. 2017 Sep;27(5):364-371. doi: 10.1053/j.jrn.2017.04.009. Epub 2017 Jun 9.
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
2009年8月1日
初级完成 (实际的)
2013年2月1日
研究完成 (实际的)
2013年3月1日
研究注册日期
首次提交
2015年2月11日
首先提交符合 QC 标准的
2015年3月4日
首次发布 (估计)
2015年3月5日
研究记录更新
最后更新发布 (估计)
2015年3月26日
上次提交的符合 QC 标准的更新
2015年3月24日
最后验证
2015年3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.
有氧运动的临床试验
-
University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的