High Intensity Aerobic Training in Persons With Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- change in VO2peak
研究概览
简要总结
The aims of this study are to assess the effects of medium versus high intensity 12-week adjusted training programs on physical capacity in persons with incomplete SCI, early after discharge from primary rehabilitation, and to investigate if the training program induces a more active lifestyle in terms of increased daily energy expenditure.
详细描述
Design:
Randomized controlled trial.
Participants:
45 subjects, between 18 and 65 years of age, will be recruited with the following inclusion criteria: Traumatic spinal cord injury, incomplete lesions (classified as ASIA D), admitted to Sunnaas Rehabilitation Hospital for primary rehabilitation, and able to walk for 5 minutes on the treadmill (without assistive aids) at 4 km/hour.
Subjects with cardiovascular diseases, progressive diseases and severe psychiatric conditions will be excluded.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury
- •incomplete lesion (classified as ASIA D)
- •admitted to Sunnaas Rehabilitation Hospital for primary rehabilitation,
- •able to walk for 5 minutes on the treadmill (without assistive aids) at 4 km/hour
排除标准
- •cardiovascular diseases
- •progressive diseases
- •severe psychiatric conditions
研究组 & 干预措施
High intensity training
Patients in this group will perform high aerobic intensity training, in 30 minutes, twice a week, in a 12 week period.
干预措施: High intensity training (Other)
Moderate intensity training
Patients in this group will perform moderate aerobic intensity training, in 45 minutes, three times a week, in a 12 week period.
干预措施: Moderate intensity training (Other)
controll
Patients in this group will perform no (additional) training.
结局指标
主要结局
change in VO2peak
时间窗: 0 months, 3 months and 12 months
Physical capacity (VO2peak) will be measured before intervention (baseline), after 3 months and after 1 year (12 months. Changes (from baseline) in VO2peak after 3 months and after one year is the primary outcome measure.
次要结局
未报告次要终点
研究者
Matthijs Ferdinand Wouda
PhD candidate
Sunnaas Rehabilitation Hospital