StrokeNCT03701035
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
A study testing Aerobic Training & UL Motor Training and Non-aerobic training & UL Motor Training in people with Stroke, run by Clare Maguire at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Aerobic Training & UL Motor Training and Non-aerobic training & UL Motor Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 8 Oct 2018to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hemiplegic stroke ischemic or intracerebral hemorrhagic > 3 months post- stroke
- Active shoulder abduction, wrist and finger extension 10 degrees from a flexed position
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Switzerland1 site
RehaB clinic for Neurorehabilitation and Paraplegiology
Basel, 4055
About this study
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.
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.
Read the 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
- Being tested
- Aerobic Training & UL Motor Training, Non-aerobic training & UL Motor Training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic Training & UL Motor TrainingBehavioural
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 TrainingBehavioural
40 minutes non-aerobic gait \& balance circuit training followed by UL motor training with the Armeo®Spring/Senso/Pablo X2®
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Training & UL Motor Training | Experimental | 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 Receives: Behavioral: Aerobic Training & UL Motor Training |
| Non-aerobic Training & UL Motor Training | Active comparator | 40 minutes non-aerobic gait \& balance circuit training followed by UL motor training with the Armeo®Spring/Senso/Pablo X2® 3 * weekly, 12 weeks Receives: Behavioral: Non-aerobic training & UL Motor Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
BDNF
Acute (immediate post exercise) and chronic (post-intervention) serum BDNF levels
Measured: 12 weeks
Action Research Arm Test (ARAT)
A 19-Item standardised assessment of UL function measuring ADLs, coordination \& dexterity.
Measured: 12 weeks
Secondary outcomes (7)
The Fugl-Meyer Assessment - Upper Extremity Scale (FMA).
Instrument for measuring upper limb impairment after stroke. The Fugl-Meyer Assessment - Upper Extremity Scale (FMA). This is reliable, responsive and valid instrument for measuring upper limb impairment after stroke. Items are scored on a three-point ordinal scale: 0=cannot perform, 1=performs partially, 2=performs fully. Maximal Score 66.
Measured: 12 weeks
10 meter walking test
A measurement of gait speed
Measured: 12 weeks
Trunk Sway in standing with eyes closed
Standing balance
Measured: 12 weeks
The Montreal Cognitive Assessment (MoCA©).
This is a rapid screen of cognitive performance to detect mild cognitive dysfunction. The test consists of 16 items and 11 categories to assess multiple cognitive domains. The maximal score is 30.
Measured: 12 weeks
Corsi Block Test
Evaluates visuospatial short-term working memory
Measured: 12 weeks
The Fatigue Severity Scale (FSS)
Measures post-stroke-fatigue. This is a 9-item, 7 point linkert scale scale which measures the effect of fatigue on activities and lifestyle. The higher the score the worse the fatigue.
Measured: 12 weeks
Stroke Impact Scale
A disease specific Quality of Life measure.This is a 59 item measure in which 8 domains are assessed. Each item is a 5-point Linkert scale related to difficulty completing the scale . Summative scores are generated for each domain. A higher score indicates a better Performance.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start8 Oct 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clare Maguire
- Sponsor type
- University, hospital or other
- Collaborators
- Bildungszetrum Gesundheit Basel-Stadt, Rehab Basel
- Responsible party
- Sponsor-investigator, Clare Maguire, Technical University of Bern
- Investigators
- Clare Maguire, PhD, Principal investigator, Bern University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701035
- Sponsor's protocol ID
- 2018-01249
- Other IDs
- 2018
- Status last verified
- Dec 2022
- First submitted
- 7 Oct 2018
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03701035
- Acronym / sponsor ID
- 2018-01249
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Clare MaguireUniversity, hospital or other
- Collaborators
- Bildungszetrum Gesundheit Basel-Stadt, Rehab Basel
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Training & UL Motor Training | Experimental | Behavioral: Aerobic Training & UL Motor TrainingAerobic 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 |
| Non-aerobic Training & UL Motor Training | Active comparator | Behavioral: Non-aerobic training & UL Motor Training40 minutes non-aerobic gait \& balance circuit training followed by UL motor training with the Armeo®Spring/Senso/Pablo X2® 3 * weekly, 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hemiplegic stroke ischemic or intracerebral hemorrhagic > 3 months post- stroke
- Active shoulder abduction, wrist and finger extension 10 degrees from a flexed position
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Training & UL Motor TrainingAerobic 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® | Behavioural | Aerobic Training & UL Motor Training |
| Non-aerobic training & UL Motor Training40 minutes non-aerobic gait \& balance circuit training followed by UL motor training with the Armeo®Spring/Senso/Pablo X2® | Behavioural | Non-aerobic Training & UL Motor Training |
Primary outcome
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.
7 secondary outcomes
The Fugl-Meyer Assessment - Upper Extremity Scale (FMA).
Time frame: 12 weeks
10 meter walking test
Time frame: 12 weeks
Trunk Sway in standing with eyes closed
Time frame: 12 weeks
The Montreal Cognitive Assessment (MoCA©).
Time frame: 12 weeks
Corsi Block Test
Time frame: 12 weeks
The Fatigue Severity Scale (FSS)
Time frame: 12 weeks
Stroke Impact Scale
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Maguire, PhD principal investigator
Bern University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Training & UL Motor Training and Non-aerobic training & UL Motor Training in people with Stroke, run by Clare Maguire at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BDNF (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.