Clinical trial NCT03701035: Moderate Intensity Aerobic Training in Sub-acute and Chronic Stroke Patients - the Influence on Brain Derived Neurotrophic Factor (BDNF) and Upper-limb Rehabilitation. A Protocol for a Randomized Control Trial and Health Economic Evaluation
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Technical University of Bern
Sponsor class: OTHER
Collaborators: name: Bildungszetrum Gesundheit Basel-Stadt
name: Rehab Basel
First posted: 2018-10-09
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. .

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

Primary outcomes:
measure: BDNF
timeFrame: 12 weeks
measure: Action Research Arm Test (ARAT)
timeFrame: 12 weeks
Secondary outcomes:
measure: The Fugl-Meyer Assessment - Upper Extremity Scale (FMA).
timeFrame: 12 weeks
measure: 10 meter walking test
timeFrame: 12 weeks
measure: Trunk Sway in standing with eyes closed
timeFrame: 12 weeks
measure: The Montreal Cognitive Assessment (MoCA©).
timeFrame: 12 weeks
measure: Corsi Block Test
timeFrame: 12 weeks
measure: The Fatigue Severity Scale (FSS)
timeFrame: 12 weeks
measure: Stroke Impact Scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: RehaB clinic for Neurorehabilitation and Paraplegiology
Study officials:
affiliation: Bern University of Applied Sciences
name: Clare Maguire, PhD
role: PRINCIPAL_INVESTIGATOR
References: