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临床试验/NCT06179173
NCT06179173招募中不适用

Is High-intensity Aerobic Interval Training Appropriate for Recovering Impairments and Activity Limitations in the Acute Phase of Stroke? A Randomized Controlled Trial in Benin

Hasselt University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月1日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
Workload capacity
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This clinical trial aims to examine the effects of combining HIIT on a semi-recumbent cycle ergometer (HIIT-RCE) with conventional physiotherapy on impairments and activity limitations in early subacute stroke. We hypothesized that HIIT combined with conventional physiotherapy would be more effective than conventional physiotherapy in improving workload capacity.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •People with the diagnosis of stroke were screened and recruited within the first-month after the stroke onset according to the following criteria
  • •first episode from an ischemic or hemorrhagic stroke confirmed by CT scan;
  • •muscle strength of the affected leg defined by Motricity Index between 14 and 19, i.e., between 2 and 4 on the Medical Research Council scale;
  • •modified Ashworth score of 0 or 1, indicating no spasticity or slight spasticity over the affected lower limb, respectively
  • •able to walk at least 5 meters independently with or without assistive devices and understand simple instructions;
  • •resident in Parakou or its surroundings
  • •wish to participate in the hospital program

排除标准

  • •Patients whose medical records reported
  • •uncontrolled cardiac arrhythmias (e.g. atrial fibrillation, ventricular tachycardia), heart failure, or recent myocardial infarction, arteriopathy,
  • •primary orthopedic conditions (e.g., fractures, active rheumatoid arthritis),
  • •other neurological diseases (such as Parkinson's disease and Alzheimer's disease), (4) patients unable to perform a graded exercise test, i.e., unable to reach the target cadence of 50 rpm or exercise-induced asthma

结局指标

主要结局

Workload capacity

时间窗: At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention

A progressive intensity maximal effort cycling test will be performed in a semi-recumbent ergometer cycle (SOLE R90) to determine each participant's peak workload (in watts).

次要结局

  • The Berg Balance Scale (BBS),(At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention)
  • The 6-minute walk test (6MWT)(At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention)
  • The 10-meter Walk Test (10mWT)(At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention)
  • The 5-Repetition Sit-To-Stand test (5R-STS)(At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months (T3) after intervention)
  • The EQ-5D-5L(At enrolment (T0), After 6 weeks of intervention (T1), 3 months (T2) and 6 months(T3) after intervention)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dominique Hansen

Full Professor of Rehabilitation and Exercise Physiology in Cardiometabolic Diseases

Hasselt University

研究点 (1)

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