Effect of a High-intensity Interval-training on "Heart Rate Variability" Prognostic Parameters in Early Post-stroke Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- SDNN
研究概览
简要总结
Objective. To assess the effect of innovative "High-Intensity Interval Training" (HIIT) on Heart Rate Variability, a strong biomarker of positive outcome after stroke.
Design. A randomized controlled study with blinded assessment of the main criteria.
Population. NIHSS<20 post-stroke patients, hospitalized in secondary care stroke-units within the first 3 months (sub-acute phase).
Selection. Eligibility test on a semi-recumbent cycloergometer Intervention. In addition to a standard neurorehabilitation program (3±1 sessions daily, including cognitive and occupational therapy, physiotherapy with strengthening-stretching exercises), the aerobic group will benefit from a HIIT procedure (HIIT group) with a semi-recumbent cycloergometer, for 6 weeks representing 16 sessions; while the non-aerobic group will undertake a "Low-Intensity Group-Gymnastic Training" (Control or LIGT Group) (=segmental strengthening-stretching and proprioceptive exercises mainly), with the same training volume and frequency for both groups.
Main outcome measure. Standard Deviation of Normal-to-Normal RR intervals (SDNN) from 24h Holter-ECG recordings at W4, W8 and M6.
Modifications in patients' medical management are expected, as generalization of AT in moderate to severe stroke patients at the sub-acute phase, with "Low volume HIIT" and simple devices.
详细描述
A randomized controlled 2-arms parallel study, comparing HRV in two groups of stroke patients.
Post-acute stroke patients hospitalized in rehabilitation stroke¬-units, within secondary care hospitals, are screened for eligibility.
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Inclusion criteria:
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first-ever hemispheric stroke, with consistent clinical and neuroimaging signs
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<3 month
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NIHSS <20 in acute care
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age>18
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Non-inclusion criteria:
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complicated diabetes mellitus with objective neuropathy and/or autonomic dysfunction
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other concomitant cardiac or pulmonary diseases possibly affecting HRV recordings, ie: acute myocardial infarction (<6 month), myocardial dysfunction as severe dilated or hypertrophic cardiomyopathy, class 3 and 4 heart failure, arrhythmias including chronic atrial fibrillation, conduction abnormalities.
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beta-blockers with no alternative options
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severe cognitive impairment inconsistent with free, informed and written consent or questionnaire filling
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Patients will benefit beforehand from a symptom-limited Graded Exercise Test (GXT), with ECG monitoring and using a semi recumbent cycle ergometer (Ergoline, Optibike MED600), mainly to exclude a CV risk and to accurately assess their exercise capacities for better individualized programs. Peak oxygen uptake, Peak Power , Peak Heart Rate, Respiratory Exchange Ratio (VO2peak, Power peak, HRpeak, RER respectively) will be measured, Ventilatory Threshold 1 (VT1) will be estimated, and oxygen uptake, power and heart rate at VT1 will be recorded (VO2vt1, Pvt1, HRvt1).
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The standard-of-care neuro-rehabilitation program was carried out according to the international recommendations. It will consist daily in a mean of 3 sessions (2 to 4), five days a week: physiotherapy (with, among others, Strengthening-Stretching activity), occupational therapy, cognitive therapy (orthophonist or neuro-psychologist).
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)
盲法说明
The evaluator of the main measurement criterion (Holter-ECG/24h) receives anonymous data by secure e-mail, without ever meeting the patients or their records.
A blind component is introduced for patients, via the information given about a comparison between 2 types of physical activity.
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
- •first-ever hemispheric stroke, with consistent clinical and neuroimaging signs
- •<3 month
- •NIHSS <20 in acute care
排除标准
- •age<18 years-old
- •diabetes mellitus complicated by neuropathy or autonomic dysfunction; or any other concomitant nervous system, cardiac or pulmonary disease possibly affecting the autonomic nervous system ie:
- •myocardial infarction< 6 months,
- •myocardial dysfunction as severe dilated or hypertrophic cardiomyopathy, class 3 and 4 heart failure,
- •severe conduction abnormalities and arrhythmias, including chronic atrial fibrillation,
- •mechanical ventilation,
- •beta-blockers with no alternative options, pharmacological mandatory treatment possibly affecting the autonomic nervous system and HRV.
- •severe cognitive impairment inconsistent with free, informed and written consent or questionnaire filling
结局指标
主要结局
SDNN
时间窗: Week 1, Week 8, Month 6
Standard Deviation of all Normal-to-Normal RR intervals, recorded with a 24h-Holter ECG.
次要结局
- HRV(Week 1, Week 8, Month 6)
- Dose Ratio(Week 2 to Week 7)
- HRV(Week 1, Week 8, Month 6)
- Dose Ratio(Week 2 to Week 7)
- VO2peak(Week1 Vs Week 8)
研究者
Benjamin BERNUZ, MD
Medecine Doctor
Hôpital Léon Bérard