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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Clare Maguire
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- BDNF
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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. .
Investigators
Clare Maguire
Head of Master Programme Neurorehabilitation
Technical University of Bern
Eligibility Criteria
Inclusion Criteria
- •Hemiplegic stroke ischemic or intracerebral hemorrhagic \> 3 months post- stroke
- •Active shoulder abduction, wrist and finger extension 10 degrees from a flexed position
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
BDNF
Time Frame: 12 weeks
Acute (immediate post exercise) and chronic (post-intervention) serum BDNF levels
Action Research Arm Test (ARAT)
Time Frame: 12 weeks
A 19-Item standardised assessment of UL function measuring ADLs, coordination \& dexterity.
Secondary Outcomes
- 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)