High-intensity Training in Patients With Lacunar Stroke (HITPALS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Difference in the 'Graded Cycling Test with Talk Test'
研究概览
简要总结
In a randomized-controlled study the effect of high-intensity training, 5 days a week at home for 12 weeks is tested in patients with lacunar stroke.
详细描述
Little is known about effect of exercise for patients with lacunar stroke, no studies have investigated the feasibility or effect of aerobic exercise in this subgroup of stroke. The patients have few and temporary symptoms and are therefore early discharged from the hospital. After an cerebral infarct the patients have increased risk of recurrent stroke and they are at risk of developing cognitive deficits or vascular dementia over time. Researchers want to investigate if high-intensity training at home in the acute phase has an effect on aerobic fitness, endothelial response and health profile in this potential fragile group of patients. We hope to increase the patients´ physical and mental function, and thereby prevent a recurrent stroke and slow the progression of vascular diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •lacunar stroke verified by clinical examination and CT- or MRI-scans
- •able to speak and read Danish
排除标准
- •previous large artery stroke,
- •symptoms or co-morbidities in the musculoskeletal system, which hinder bicycling,
- •dyspnoea caused by heart or pulmonary disease,
- •aphasia or dementia which hinder completion of the Talk Test.
- •Amendment 1 (version 4.0, June 2016) has been modified to allow an extended inclusion period from 0-21 days (previously 0-7 days).
- •Also, to allow inclusion of patients with recurrent lacunar stroke, with clinical symptoms and a corresponding ischemic lesion on MRI.
- •Amendment 2 (version 5.0, June 2017) has allowed inclusion from two other stroke units in the Capital Region of Copenhagen due to low recruitment rate. The article describes protocol version 5.0 from June 6th. 2017
研究组 & 干预措施
Exercise
Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks
干预措施: prophylactic stroke medication (Drug)
Control
Prophylactic stroke medication and recommendations for lifestyle changes
干预措施: prophylactic stroke medication (Drug)
Control
Prophylactic stroke medication and recommendations for lifestyle changes
干预措施: Recommendations for lifestyle changes (Behavioral)
Exercise
Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks
干预措施: High-intensity training (Other)
Exercise
Prophylactic stroke medication and recommendations for lifestyle changes AND high-intensity training at home, 5 days a week in 12 weeks
干预措施: Recommendations for lifestyle changes (Behavioral)
结局指标
主要结局
Difference in the 'Graded Cycling Test with Talk Test'
时间窗: at baseline, 3 (primary analysis), 6 and 12 months after baseline testing
Sub-maximal exercise test on a stationary bicycle
次要结局
- Magnetic resonance Imaging (MRI)(12 months after baseline testing)
- Endothelial response(at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
- The WHO-five Well-being Index (WHO-5)(at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
- Montreal Cognitive Assessment (MOCA)(at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
- Ull-Meter(At baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
- Major Depression Inventory (MDI)(at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
- Physical Activity Scale (PAS)(at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
- Multidimensional Fatigue Inventory (MFI-20)(at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
- Blood samples(at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
- Short time activity measurements(at baseline, 3 (primary analysis), 6 and 12 months after baseline testing)
研究者
Christina Kruuse
Associate professor, consultant neurologist
Herlev Hospital