Effect of Wheelchair-modified Upper-body Rowing Exercise on Traditional and Novel Cardiometabolic Risk Factors in Spinal Cord Injured Wheelchair Users - Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- fasting insulin
研究概览
简要总结
This randomized controlled trial will determine the effects of 12-weeks of wheelchair user-modified upper-body rowing on both traditional cardiometabolic risk factors in SCI manual wheelchair users.
详细描述
This randomized controlled trial aims to determine the effects of 12-weeks of wheelchair user-modified upper-body rowing on both traditional (insulin resistance, obesity, dyslipidemia (including low HDL-C and elevated TG and blood pressure) and novel (inflammatory status, autonomic nervous system function, vascular structure and function, and cardiorespiratory fitness level) cardiometabolic risk factors in SCI manual wheelchair users. As secondary objectives, this trial will investigate the effects of the exercise intervention on free-living physical activity, shoulder pain, and indices of quality of life.
Men and women, aged 18-65 years; chronic SCI (≥1 year since injury); individuals with sufficient sparing of arm function to participate in upper-body rowing; using a manual wheelchair as a primary tool for mobility will be included in the trial.
The exercise training will be conducted as wheelchair-modified upper-body ergometer rowing. The training will be performed for up to 30 min, 3 times per week with moderate-to-vigorous intensity, with at least one rest day between sessions.
Outcome measurements will be performed immediately before (baseline), after (post) 12 weeks of training, and 6 months after the termination of the intervention period (follow up). This approach allows for assessment of the short term effects of exercise training as well as any residual effects from the training intervention on cardiometabolic risk, shoulder pain, indices of quality of life, and free-living physical activity
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- 是
入选标准
- •18-65 years;
- •chronic SCI (≥1 year since injury)
- •individuals with sufficient sparing of arm function to participate in upper-body rowing (i.e. as a minimum excluding individuals with complete SCI at or above C5)
- •using a manual wheelchair as a primary tool for mobility.
排除标准
- •Individuals who regularly engage in >150 min/week of moderate-to-vigorous intensity physical activity
- •have received a cortisone injection in the shoulder within the last four months
- •have had shoulder injury within the previous year
- •known medical issues (urinary tract infections, cardiovascular contraindications for exercise testing, and pressure sores)
- •diagnosed diabetes or any endocrine, heart, kidney, liver disease or any other disease that may limit the ability to perform exercise.
结局指标
主要结局
fasting insulin
时间窗: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Serum fasting insulin concentration will be measured from approximately 20 mL blood drawn from a peripheral vein
次要结局
- Vascular structure(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Free-living physical activity(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Arterial blood pressure(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Body mass(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Shoulder pain(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Heart rate variability (HRV)(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Health-related quality of life (HRQOL)(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Waist Circumference(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Conduit artery function(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- LDL cholesterol(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Alanin-aminotransferase(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Fasting blood glucose(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Cardiorespiratory fitness level(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- body mass index(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Resistance vessel function(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- HDL cholesterol(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- C-reactive protein(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Interleukin 6(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Tumor necrosis factor-alpha(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Vascular function(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Long-term blood glucose(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Triglyceride(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Interleukin-1 receptor antagonist(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
- Interleukin-10(The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint))
研究者
Rasmus Kopp Hansen
Principal Investigator
Aalborg University