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

NCT ID: NCT03701035

Last Updated: 2022-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-08
• Study Completion Date: 2020-09-01

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. .

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic Training & UL Motor Training

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

Group Type: EXPERIMENTAL

Aerobic Training & UL Motor Training

Intervention Type: BEHAVIORAL

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®

Non-aerobic Training & UL Motor Training

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

Group Type: ACTIVE_COMPARATOR

Non-aerobic training & UL Motor Training

Intervention Type: BEHAVIORAL

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

Interventions

Aerobic Training & UL Motor Training

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®

Intervention Type: BEHAVIORAL

Non-aerobic training & UL Motor Training

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bildungszetrum Gesundheit Basel-Stadt

UNKNOWN

Sponsor Role: collaborator

Rehab Basel

OTHER

Sponsor Role: collaborator

Clare Maguire

OTHER

Sponsor Role: lead

Responsible Party

Clare Maguire

Head of Master Programme Neurorehabilitation

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Clare Maguire, PhD

Role: PRINCIPAL_INVESTIGATOR

Bern University of Applied Sciences

Locations

RehaB clinic for Neurorehabilitation and Paraplegiology

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2018-01249

Identifier Type: -

Identifier Source: org_study_id