Does Moderate Intensity Aerobic Training Influence Serum Levels of BDNF in Sub-acute and Chronic Stroke Patients and Consequently Increase the Efficacy of Upper-limb Rehabilitation? A Study Protocol for a Randomized Control Trial With an Embedded Health Economic Evaluation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- BDNF
研究概览
简要总结
The aim of this study is to evaluate the influence on three different training modalities on the blood concentration levels of a growth factor called Brain Derived Neurotrophic Factor (BDNF) and on the recovery of arm function following in sub-acute and chronic stroke survivors. The training modalities are 1. moderate intensity aerobic training on a bike ergonometer followed by robotic or sensor-based upper-limb training, 2. non-aerobic circuit training followed by robotic or sensor-based upper-limb training 3. circuit training alone.
详细描述
Background and Rationale:Brain-derived neurotrophic factor (BDNF) belongs to a group of neurotrophins which influence neuroplasticity by increasing long-term potentiation and axonal and dendritic growth. Levels of serum BDNF are increased following moderate intensity aerobic exercise (MAE) in animal and healthy subjects. The influence of MAE on BDNF following stroke and the resultant efficacy of motor training in this environment remains unclear.
Objective(s):To investigate the influence of MAE on acute and chronic levels of serum BDNF in sub-acute and chronic stroke patients, the efficacy of robotic upper limb or sensor based motor task training in this environment and consequent effect on functional arm recovery compared to the same upper limb training following non-aerobic training circuit training, or non-aerobic circuit training alone To evaluate the cost-effectiveness of the interventions. Study Interventions: Group 1: moderate intensity AE 40 minutes, 3 times weekly followed after 20 minutes break by 40 minutes robotic or sensor-based upper-limb Training. Group2: non-aerobic gait and balance circuit training 40 mins 3 times weekly followed after 20 minutes break by 40 minutes robotic or sensor-based upper-limb training, group 3: 40 minutes non-aerobic gait and balance circuit training.In total 45 participants will be enrolled - 15 in each group.Study Duration:3 monthly Intervention period per intervention group, with a 3 month and 6 month follow-up. .
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
- 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
- •Hemiplegic stroke ischemic or intracerebral hemorrhagic > 3 months post- stroke
- •Active shoulder abduction, wrist and finger extension 10 degrees from a flexed position
排除标准
- •Contraindications to maximal exercise testing according to the American College of Sports Medicine guidelines
- •Severe perceptual problems
- •Concurrent neurological diagnoses e.g. Parkinsons disease
- •Comorbidities which may interfere with exercise participation
- •Significant cognitive impairment < 24 on the Montreal Cognitive Assessment Scale
结局指标
主要结局
BDNF
时间窗: 12 weeks
Acute (immediate post exercise) and chronic (post-intervention) serum BDNF levels
Action Research Arm Test (ARAT)
时间窗: 12 weeks
A 19-Item standardised assessment of UL function measuring ADLs, coordination \& dexterity.
次要结局
- The Fugl-Meyer Assessment - Upper Extremity Scale (FMA).(12 weeks)
- 10 meter walking test(12 weeks)
- Trunk Sway in standing with eyes closed(12 weeks)
- Corsi Block Test(12 weeks)
- The Montreal Cognitive Assessment (MoCA©).(12 weeks)
- The Fatigue Severity Scale (FSS)(12 weeks)
- Stroke Impact Scale(12 weeks)
研究者
Clare Maguire
Head of Master Programme Neurorehabilitation
Technical University of Bern