The Effect of High-intensity Interval Training on Biomarkers of Cardiometabolic Health in Persons With Chronic Paraplegia: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Peak power output
研究概览
简要总结
Persons with chronic paraplegia at an increased risk of developing cardiovascular disease and type-2 diabetes compared to the able-bodied population. There is mounting evidence from the able-bodied literature that high-intensity interval training (HIIT) is an effective way to improve cardiometabolic health outcomes, but this effect has yet to be investigated in persons with chronic paraplegia.
This study is recruiting adults (aged 18-65 years) with paraplegia (T2 or below) who sustained their spinal cord injury more than one-year ago. Participants will need to attend the laboratory at the University of Bath on two occasions (baseline and follow-up testing) separated by eight weeks. Following the first visit, participants will be randomised to a exercise group or control group. For those in the exercise group, participants will be provided with an arm crank ergometer for use in their home, and be asked to perform four exercise sessions per week (30 min each) for six weeks. For those in the control group, participants will be asked to continue their normal lifestyle.
详细描述
The aim of this research is to determine the effect of HIIT (vs. a control group) on biomarkers of cardiometabolic health in persons with chronic paraplegia.
Baseline and follow-up assessments:
Before each visits, participants will be asked to refrain from any strenuous physical activity (2 days prior), consume no caffeine (including tea or coffee) or alcohol (1 day prior), and have fasted for at least 10 hours overnight before arriving to the University of Bath laboratories.
There will be measurements of basic anthropometrics (height, weight, waist and hip circumference), body composition (via a DEXA scan), resting metabolic rate, sub-maximal and maximal exercise capacity, and blood responses following the consumption of a sugary drink.
Physical activity and diet monitoring:
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
- 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
- •Individuals with a chronic (>12 months post-injury) SCI below T2
- •Individuals who spend >75% of their waking day in a wheelchair
- •Weight stable (weight not changed by >3% over the last 3 months)
排除标准
- •Individuals who an acute (<12 months post-injury) SCI
- •Individuals who spend <75% of their waking day in a wheelchair
- •Individuals on type-2 diabetes medication
- •Individuals self-reporting active medical issues (pressure sores, urinary tract infections, cardiac disorders, musculoskeletal complaints of the upper extremities, or cardiovascular contraindications to exercise testing)
- •Plans to change lifestyle during the study period
结局指标
主要结局
Peak power output
时间窗: 6 weeks
Maximum power output achieved during peak aerobic capacity test
Fasting insulin
时间窗: 6 weeks
Serum insulin concentration
Peak aerobic capacity
时间窗: 6 weeks
Measured using a incremental ramp protocol on a arm crank ergometer
次要结局
- Body mass(6 weeks)
- Total body fat percentage(6 weeks)
- Waist and hip circumference(6 weeks)
- Systolic and diastolic blood pressure(6 weeks)
- Resting metabolic rate(6 weeks)
- Total Fat-Free Mass(6 weeks)
- Time spent in different physical activity intensities (MET categories) (minutes)(6 weeks)
- Postprandial metabolites(6 weeks)
- Shoulder Pain(6 weeks)
- Fatigue(6 weeks)
- Independence(6 weeks)
- Exercise Self-Efficacy(6 weeks)
- Total Fat Mass(6 weeks)
- Visceral Adipose Tissue(6 weeks)
- Fasting metabolite/hormone/inflammatory profile(6 weeks)
- Health-related quality of life(6 weeks)
- Energy expended in different physical activity intensities (MET categories) (kJ or kcal)(6 weeks)
- Energy intake and dietary macronutrient composition(6 weeks)
研究者
James Bilzon
Professor
University of Bath