ISRCTN57514022进行中（未招募）未知
A feasibility study of high-intensity interval training to reduce cardiometabolic disease risks in individuals with acute spinal cord injury
niversity of Bath0 个研究点目标入组 40 人开始时间: 2021年5月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36737096/ (added 06/02/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females
- •2. Aged greater than 18 years
- •3. Individuals who have had their SCI for less than 6 months (any level injury/AIS grade assuming the remaining criteria are met)
- •4. Sufficient upper extremity motor function to complete arm crank ergometry exercise (we will acquire visual confirmation of the participant's ability to perform four upper extremity movements: elbow flexion against gravity, wrist extension against gravity, elbow extension against gravity, and making a fist with the thumb on the outside)
- •5. Use a wheelchair for at least 75% of their day
排除标准
- •Current exclusion criteria as of 15/11/2022:
- •Individuals presenting with any of the following will be excluded from participating in the trial:
- •1. Unresolved pressure ulcer
- •2. Upper limb pain that limits exercise
- •3. Recurrent acute infection or illness
- •4. Previous (<4 weeks) MI or cardiac surgery
- •5. Intubation or tracheostomy
- •6. Individuals who self-report significant upper extremity pain (score of > 60 on the Wheelchair Users Shoulder Pain Index (WUSPI)
- •7. Women who become pregnant will be advised to notify clinical staff, and upon notification, will be withdrawn from the trial.
- •8. Cognitive impairment deemed a risk by the healthcare team for participation in the trial (e.g. diagnosis of neurodegenerative disease)
- •9. Unable to understand explanations and/or provide informed consent
- •10. Any condition and/or behaviour that would pose undue personal risk or introduce bias into the trial
- •Previous exclusion criteria:
- •Individuals presenting with any of the following will be excluded from participating in the trial:
- •1. Unresolved pressure ulcer
- •2. Upper limb pain that limits exercise
- •3. Recurrent acute infection or illness
- •4. Previous MI or cardiac surgery
- •5. Taking medications for diagnosed type 1 or 2 diabetes
- •6. Intubation or tracheostomy
- •7. Currently taking anti-hypertensive medication (excluding drugs for acute autonomic dysreflexia)
- •8. Individuals who self-report significant upper extremity pain (score of > 60 on the Wheelchair Users Shoulder Pain Index (WUSPI)
- •9. Women who become pregnant will be advised to notify clinical staff, and upon notification, will be withdrawn from the trial.
- •10. Cognitive impairment deemed a risk by the healthcare team for participation in the trial (e.g. diagnosis of neurodegenerative disease)
- •11. Unable to understand explanations and/or provide informed consent
- •12. Any condition and/or behaviour that would pose undue personal risk or introduce bias into the trial
研究者
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