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临床试验/NCT07725952
NCT07725952尚未招募不适用

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

Pusan National University Yangsan Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年10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
尚未招募
入组人数
20
试验地点
1
主要终点
Heart Rate Variability

研究概览

简要总结

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.

详细描述

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.

研究设计

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

入排标准

年龄范围
19 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Exercise group

Experimental

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.

干预措施: Upper-Limb Resistance Training (Behavioral)

Control group

No Intervention

Participants will continue their usual daily activities without participating in the resistance training program during the 8-week study period.

结局指标

主要结局

Heart Rate Variability

时间窗: Baseline and Week 8

Heart rate variability will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.

Baroreflex Sensitivity

时间窗: Baseline and Week 8

Baroreflex sensitivity will be assessed to evaluate changes in cardiovascular autonomic function following the 8-week intervention.

次要结局

  • Orthostatic Hypotension(Baseline and Week 8)
  • Grip Strength(Baseline and Week 8)
  • Orthostatic Hypotension Symptoms (ADFSCI)(Baseline and Week 8)
  • Quality of Life (WHOQOL-BREF)(Baseline and Week 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sungchul Huh

Assistant professor

Pusan National University Yangsan Hospital

研究点 (1)

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