此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Physical Exercise in Patients With Chronic Kidney Disease in Hemodialysis (Pehedal-ESKD) (Pehedal-ESKD)

2026年9月14日 更新者：Ricerca Nefrocenter

Physical Exercise in Hemodialysis Patients in End Stage Kidney Disease

The goal of this clinical trial is to learn whether different types of exercise performed during hemodialysis are safe, well tolerated, and beneficial for adults receiving maintenance hemodialysis. The main questions it aims to answer are:

  • Are aerobic exercise using a cycle ergometer and resistance exercise using elastic bands well tolerated during hemodialysis?
  • Do these exercise programs improve physical function, body composition, quality of life, and dialysis-related outcomes compared with standard care?

Researchers will compare aerobic exercise, resistance exercise, and standard hemodialysis care to evaluate differences in tolerance and health outcomes.

Participants will:

  • Be assigned to one of three groups: cycle ergometer exercise, elastic-band resistance exercise, or standard care.
  • Attend hemodialysis sessions as scheduled.
  • Complete physical performance and body composition assessments at baseline and after 6 months.
  • Complete questionnaires about health and quality of life.

The results of this study may help identify effective exercise strategies to improve health and well-being in people receiving long-term hemodialysis treatment.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

312

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。

学习联系方式

学习地点

  • 意大利
      • Torre del Greco、意大利、80059
        • 招聘中
        • NefroCenter Dialysis Centers
        • 接触：
        • 首席研究员：
          • Ersilia Satta, PhD MD

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age ≥18 years.
  • Receiving maintenance hemodialysis for more than 3 months.
  • Clinically stable condition.
  • Ability and willingness to provide written informed consent.

Exclusion Criteria:

  • Unstable angina.
  • Uncontrolled hypertension.
  • Any medical condition judged by the treating nephrologist to contraindicate or make intradialytic exercise unsafe

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：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
有源比较器：Cycle ergometer
Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times per week for a total of 150 minutes per week at moderate intensity, corresponding to a Borg Rating of Perceived Exertion of 12-13. Training sessions were supervised by qualified exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
行为的：Intradialytic aerobic exercise using a cycle ergometer
Participants performed supervised intradialytic aerobic exercise using a cycle ergometer during the first 2 hours of hemodialysis sessions. Exercise was conducted three times weekly for a total of 150 minutes per week at moderate intensity (Borg Rating of Perceived Exertion 12-13). Sessions were supervised by exercise professionals and monitored by dialysis nurses to ensure safety and adherence.
有源比较器：Elastic band resistance training
Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times per week for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance was progressively adjusted according to individual tolerance and correct exercise execution. Sessions were supervised by exercise professionals and monitored by dialysis nurses.
行为的：Intradialytic elastic-band resistance exercise
Participants performed supervised intradialytic resistance exercise using progressive color-coded elastic bands during the first 2 hours of hemodialysis sessions. Training was conducted three times weekly for a total of 150 minutes per week at moderate intensity and targeted both upper and lower limbs. Resistance levels were progressively adjusted according to individual tolerance and proper exercise execution.
无干预：Control
Participants received standard hemodialysis care and continued their usual activities during dialysis sessions without participation in a structured intradialytic exercise program. Clinical assessments and follow-up evaluations were performed according to the study protocol.

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
Incidence of intradialytic intolerance and hemodynamic instability
大体时间：Baseline to 6 months
Exercise tolerability will be evaluated through the incidence of intradialytic intolerance events and the maintenance of hemodynamic stability during hemodialysis sessions. Hemodynamic monitoring will include systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate measured before, during, and after exercise sessions. Clinical signs and symptoms of exercise intolerance, including hypotension, dizziness, muscle cramps, nausea, premature interruption of exercise, or other adverse events occurring during dialysis, will be recorded. Outcomes will be compared among cycle ergometer exercise, elastic-band resistance training, and combined exercise programs to assess the relative tolerability and safety of each intervention.
Baseline to 6 months

次要结果测量

结果测量
措施说明
大体时间
Maximal workload during cycle ergometer stress testing
大体时间：Baseline to 6 months
Changes in maximal workload achieved during cycle ergometer stress testing.
Baseline to 6 months
Six-minute walk test distance
大体时间：Baseline and 6 months
Changes in distance covered during the 6-minute walk test as a measure of functional exercise capacity.
Baseline and 6 months
Step-test performance
大体时间：Baseline and 6 months
Changes in step-test performance as an indicator of functional mobility and lower-limb performance.
Baseline and 6 months
Chair-stand test performance
大体时间：Baseline and 6 months
Changes in the number of repetitions completed during the chair-stand test as a measure of lower-limb muscle function.
Baseline and 6 months
Handgrip strength
大体时间：Baseline and 6 months
Changes in handgrip strength measured using a hand dynamometer.
Baseline and 6 months
Weekly exercise time
大体时间：Throughout the 6-month intervention period
Changes in the total amount of exercise completed per week during the intervention period.
Throughout the 6-month intervention period
Fat-free mass and fat mass
大体时间：Baseline to 6 months
Changes in fat-free mass and fat mass assessed by bioelectrical impedance analysis, both reported as percentage of body weight.
Baseline to 6 months
Bone mineral content
大体时间：Baseline and 6 months
Changes in bone mineral content assessed by radiofrequency echographic multi-spectrometry (REMS).
Baseline and 6 months
Bone mineral status (T-score)
大体时间：Baseline and 6 months
Changes in T-score as an indicator of bone mineral status.
Baseline and 6 months
Appendicular skeletal muscle mass index (ASMMI)
大体时间：Baseline and 6 months
Changes in appendicular skeletal muscle mass index (ASMMI) as a measure of skeletal muscle mass.
Baseline and 6 months
Anthropometric circumferences
大体时间：Baseline and 6 months
Changes in upper-limb, lower-limb, and trunk circumferences measured using standardized anthropometric procedures.
Baseline and 6 months
Health-related quality of life
大体时间：Baseline to 6 months
Changes in health-related quality of life assessed using the Sarcopenia Quality of Life (SARQoL) questionnaire. The SARQoL questionnaire generates an overall score ranging from 0 to 100, with higher scores indicating better quality of life.
Baseline to 6 months
Medication burden
大体时间：Baseline to 6 months
Changes in the number of prescribed medications and antihypertensive drugs between baseline and follow-up.
Baseline to 6 months
Dialysis adequacy
大体时间：Baseline to 6 months
Changes in dialysis adequacy expressed as Kt/V.
Baseline to 6 months
Dialysis session duration
大体时间：Baseline and 6 months
Changes in the duration of the hemodialysis session (min).
Baseline and 6 months
Blood flow rate
大体时间：Baseline and 6 months
Changes in blood flow rate (Qb) during hemodialysis.
Baseline and 6 months

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。

赞助

Ricerca Nefrocenter

合作者

Federico II University
University of Naples

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。

有用的网址

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)

2024年6月1日

初级完成 (实际的)

2025年10月1日

研究完成 (估计的)

2027年3月1日

研究注册日期

首次提交

2026年8月24日

首先提交符合 QC 标准的

2026年9月14日

首次发布 (实际的)

2026年9月15日

研究记录更新

最后更新发布 (实际的)

2026年9月15日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 0079556CE
  • CUP E63C22002050006 (其他赠款/资助编号：National Recovery and Resilience Plan (PNRR), Age-It - Spoke 4)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

IPD 计划说明

The decision regarding sharing of individual participant data (IPD) has not yet been finalized. Data sharing will be evaluated after study completion, taking into account ethical, legal, privacy, and data protection requirements.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

订阅