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Cardiovascular Autonomic Function After Resistance Training

2026年9月2日 更新者:Sungchul Huh、Pusan National University Yangsan Hospital

Effects of 8-Week Resistance Training on Cardiovascular Autonomic Function in Spinal Cord Injury

The purpose of this clinical trial is to evaluate whether an 8-week upper-limb resistance training program improves cardiovascular autonomic function in adults with chronic spinal cord injury (SCI). The primary objectives are to determine whether upper-limb resistance training improves heart rate variability (HRV) and baroreflex sensitivity (BRS), and whether it improves blood pressure responses during postural change, upper-limb strength, symptoms related to orthostatic hypotension, and quality of life.

Participants will be randomly assigned to either the resistance training group or the control group. All participants will complete assessments before and after the 8-week study period, including measurements of HRV, BRS, blood pressure responses during a tilt-table test, hand grip strength, and questionnaires assessing orthostatic hypotension symptoms and quality of life. Participants assigned to the resistance training group will participate in supervised upper-limb resistance training three times per week for 8 weeks.

研究概览

地位

尚未招聘

条件

详细说明

SCI can impair cardiovascular autonomic function by disrupting the neural pathways that regulate heart rate and blood pressure. As a result, many individuals with SCI experience cardiovascular autonomic dysfunction, including orthostatic hypotension, which may increase cardiovascular health risks.

Although exercise is recommended for people with SCI, previous studies have mainly focused on aerobic exercise and have demonstrated inconsistent effects on cardiovascular autonomic function. Upper-limb resistance training is widely used in rehabilitation to improve strength and functional independence, but its effects on autonomic function have not been well established.

This randomized controlled trial will evaluate whether an 8-week upper-limb resistance training program improves cardiovascular autonomic function in adults with chronic SCI. The study will assess changes in HRV and BRS, while also exploring changes in orthostatic blood pressure responses, upper-limb strength, orthostatic hypotension symptoms, and quality of life. The findings may provide evidence supporting upper-limb resistance training as a rehabilitation strategy to improve cardiovascular autonomic function in individuals with chronic SCI.

研究类型

介入性

注册 (估计的)

20

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

研究联系人备份

学习地点

    • Gyeongsangnam-do
      • Yangsan、Gyeongsangnam-do、韩国、50612
        • Pusan National University Yangsan Hospital
        • 接触:
        • 接触:
        • 首席研究员:
          • Sungchul Huh, MD, PhD

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:

  • Provided written informed consent and agreed to participate in the study.
  • Adults aged 19 to 85 years.
  • Chronic spinal cord injury (SCI) of traumatic or non-traumatic etiology, at least 6 months after injury.
  • Cervical or thoracic spinal cord injury.
  • Classified as American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, C, or D.
  • Sufficient upper-limb range of motion to perform resistance training.
  • Elbow extensor muscle strength of Manual Muscle Test (MMT) grade 3 or higher.

Exclusion Criteria:

  • Presence of any serious medical condition that would preclude participation in the study.
  • Inability to understand or perform the exercise program.
  • Uncontrolled diabetes mellitus or progressive neurological disease.
  • Uncontrolled hypertension (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg).
  • History of cardiovascular disease within the past 6 months.
  • Current use of medications that may affect heart rate variability (HRV) or baroreflex sensitivity (BRS).
  • Severe orthostatic hypotension (OH) or autonomic dysreflexia (AD).
  • Considered unsuitable for participation in the study by a board-certified specialist in Physical and Rehabilitation Medicine.

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:Exercise group
Participants will receive a supervised upper-limb resistance training program three times per week for 8 weeks. The program consists of progressive resistance exercises for the upper extremities.
Participants will perform a supervised upper-limb resistance training program three times per week for 8 weeks. Each session will last approximately 30 minutes and consist of progressive resistance exercises for the upper extremities. Exercise intensity will be progressively adjusted according to each participant's tolerance.
无干预:Control group
Participants will continue their usual daily activities without participating in the resistance training program during the 8-week study period.

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
Heart Rate Variability
大体时间:Baseline and Week 8
Heart rate variability will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.
Baseline and Week 8
Baroreflex Sensitivity
大体时间:Baseline and Week 8
Baroreflex sensitivity will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.
Baseline and Week 8

次要结果测量

结果测量
措施说明
大体时间
Orthostatic Hypotension
大体时间:Baseline and Week 8
Orthostatic hypotension will be assessed by changes in systolic and diastolic blood pressure (ΔSBP and ΔDBP) during postural change using a tilt table. Orthostatic hypotension will be defined as a decrease in systolic blood pressure of ≥20 mmHg or diastolic blood pressure of ≥10 mmHg.
Baseline and Week 8
Grip Strength
大体时间:Baseline and Week 8
Grip strength will be measured using a hand dynamometer to evaluate changes in upper-limb muscle strength following the intervention.
Baseline and Week 8
Orthostatic Hypotension Symptoms (ADFSCI)
大体时间:Baseline and Week 8
Orthostatic hypotension-related symptoms will be assessed using the orthostatic hypotension items of the Autonomic Dysfunction Following Spinal Cord Injury (ADFSCI) questionnaire.
Baseline and Week 8
Quality of Life (WHOQOL-BREF)
大体时间:Baseline and Week 8
Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire.
Baseline and Week 8

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:Sungchul Huh, MD, PhD、Pusan National University Yangsan Hospital

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 (估计的)

2026年10月1日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年7月21日

首先提交符合 QC 标准的

2026年7月21日

首次发布 (实际的)

2026年7月24日

研究记录更新

最后更新发布 (实际的)

2026年9月3日

上次提交的符合 QC 标准的更新

2026年9月2日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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.

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