Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03701035
Status:
COMPLETED
Last Update Posted:
2022-12-29
First Post:
2018-10-07
Brief Title:
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
Sponsor:
Clare Maguire
Organization:
Technical University of Bern
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 RationaleBrain-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
ObjectivesTo 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 trainingIn total 45 participants will be enrolled - 15 in each groupStudy Duration3 monthly Intervention period per intervention group with a 3 month and 6 month follow-up
ObjectivesTo 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 trainingIn total 45 participants will be enrolled - 15 in each groupStudy Duration3 monthly Intervention period per intervention group with a 3 month and 6 month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None