跳至主要内容
临床试验/CTRI/2025/08/093169
CTRI/2025/08/093169尚未招募不适用

Effect of Arm Cycle Ergometer Training on Heart Rate Variability and Physical Capacity in Paraplegics.

Priyanshi Sharma1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Heart rate Variability

研究概览

简要总结

Spinal cord injury (SCI) causes motor, sensory, and autonomic dysfunction, with higher-level injuries (above T6) leading to greater autonomic dysfunction which depends on injury level due to imbalance in parasympathetic and sympathetic nervous system. Heart rate variability (HRV) which is a key marker for assessment of autonomic function is often reduced in SCI . Physical activity may improve HRV in SCI.

This study aims to investigate the effects of an 4 week arm cycle ergometer (ACE) training program on autonomic function and physical capacity in individuals with  thoracic spinal cord injury (SCI). Thirty participants will be stratified into two groups based on  level of injury (T1–T6 and T7–T12). Primary outcome will be heart rate variability (HRV), and secondary outcome will be the 6-minute push test (6MPT). Assessments will be conducted at baseline and post-intervention. The study will analyze whether level of injury influences the response to ACE training, with the goal of improving cardiovascular health and functional performance in the SCI population.

Intervention Summary: Participants will undergo an arm cycle ergometer (ACE) aerobic exercise program, 5 days/week for 4 weeks. The program is designed with gradual progression in both duration and intensity.

Each session will follow a structured format for both the groups.

Warm-up: 5 minutes ( upper extremity stretching )

Main exercise: ACE training , with duration increasing weekly:

Week 1: 10 minutes per day

Week 2: 15 minutes per day

Week 3: 15 minutes per day

Week 4: 20 minutes per day

Cool-down: 5 minutes (resistance-free ACE)

Intensity: Borg CR-10 scale mild in Weeks 1 to 2 and moderate in Weeks 3 to 4.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Level of injury: T1 – T12 (AIS-A, B, C) Individual who use a wheel chair for more than 75% of the time they are awake.

排除标准

  • Person with neurological deficits (other than SCI)and pre-diagnosed psychiatric illness.
  • Clinically diagnosed of unstable angina or MI within post 1 month.
  • Resting HR more than 120 bpm Systolic BP more than 180 mmHg and Diastolic BP more than 100 mmHg. Participants on medication that affects the regulation of heart rate (such as b-blockers, etc.) Individual diagnosed with medical issues such as pressure sores, urinary tract infections, cardiac disorders, or musculoskeletal complain of upper extremities will be excluded.

结局指标

主要结局

Heart rate Variability

时间窗: Baseline and at the end of training

[SDNN]

时间窗: Baseline and at the end of training

次要结局

  • 6 minute push test

研究者

发起方
Priyanshi Sharma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Priyanshi Sharma

Indian Spinal Injuries Center- Institute of Rehabilitation Sciences

研究点 (1)

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