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

Clare Maguire

Status: Completed

Conditions: Stroke

Treatments: Behavioral: Aerobic Training & UL Motor Training; Behavioral: Non-aerobic training & UL Motor Training

Study type: Interventional

Funder types: Other

Identifiers

NCT03701035

2018-01249

Details and patient eligibility

About

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.

Full 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. .

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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17 participants in 2 patient groups

Aerobic Training & UL Motor Training

Experimental group

Description:

Aerobic training at 40%-59% Heart Rate Reserve (AT) increasing from personal maximum time (if \< 40 mins) to 40 minutes followed by UL motor training with the Armeo®Spring/Senso/Pablo X2® 3 \* weekly, 12 weeks

Treatment:

Behavioral: Aerobic Training & UL Motor Training

Non-aerobic Training & UL Motor Training

Active Comparator group

Description:

40 minutes non-aerobic gait \& balance circuit training followed by UL motor training with the Armeo®Spring/Senso/Pablo X2® 3 \* weekly, 12 weeks

Treatment:

Behavioral: Non-aerobic training & UL Motor Training