"Feasibility of High-intensity Interval Training (HIIT) as Hybrid Exercise Using Functional Electrical Stimulation Leg-cycling (FEScycling) and Ski Ergometer (SkiErg) With the Arms for People With Chronic Spinal Cord Injury Paraplegia"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Number of serious adverse events
研究概览
简要总结
This study examines safety and feasibility of a study protocol using a combination of functional electrical legcycling with voluntary armwork (hybrid training) as either skiergometer or armcycling in high intensity intervals for persons with spinal cord injury paraplegia.
详细描述
Cardiovascular disease is one of the most common causes of early death in people with spinal cord injury. Physical activity at high intensity is known to reduce the risk of cardiovascular disease in other patient groups.
During aerobic training, combining functional electrical stimulation (FES) with voluntary arm-work induces a higher oxygen uptake than FES cycling alone and high intensity interval training induces higher oxygen uptake than training at continuous intensity. The hypothesis is that combining hybrid training with high-intensity induces even higher oxygen uptake thereby reducing the risk of cardiovascular disease. This training modality has not been tested before, so before conducting a randomized controlled trial testing the effect of this training modality on oxygen uptake, the aim was to asses safety and feasibility of this protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •spinal cord injury paraplegia,
- •complete and incomplete lesions,
- •ability to be electrically stimulated,
- •willing to train 3 times a week at high intensity
排除标准
- •heart pacemaker or other heart problems contradicting high intensity aerobic training,
- •pregnancy,
- •unstable fractures,
- •heterotopic ossification,
- •myositis ossificans,
- •severe osteoporosis,
- •pressure ulcers,
- •newly implanted metal,
- •newly surgery,
- •frequent episodes of autonomic hyperreflexia,
- •very high or low blood pressure,
- •dislocation or subluxation of joints
- •high level of shoulder pain at study start.
结局指标
主要结局
Number of serious adverse events
时间窗: 8 weeks
Assessed by number of incidences of autonomic hyperreflexia or acute cardiac events
intensity
时间窗: 8 weeks
Assessed as mean intensity of the 4 x 4 min. intervals as proportion of peak watt measured at baseline test. Peakwatt for FES-cycling was defined as an average of the three highest watt values within 30 sec. For skiergometer peak watt was defined as the highest average of one min. splits.
Shoulder pain
时间窗: 8 weeks
Measured using Wheelchair Shoulder Pain Index (WUSPI), a 15 item questionnaire measuring shoulder pain during daily activities. Each item is scored on a 10 mm visual analog scale with anchors no pain to worst pain ever. Total index score range from 0 - 100. Within each item there is a not applicable option. The score used is performance corrected WUSPI score, dividing total index score by number of item responses and multiplied by 15. Higher score indicate higher level of shoulder pain.
compliance
时间窗: 8 weeks
Assessed with number of dropouts and proportion of fulfilled training minutes
次要结局
- Peak oxygen uptake(8 weeks)
- leisure time physical activity(8 weeks)
- health related quality of life(8 weeks)
- Fatigue(8 weeks)