Stroke, IschemicNCT06824116
The Effect of Endurance Training on Motor and Cognitive Functions and Concentration of Biomarkers in Post-stroke Patients
A study testing Exercise in people with Stroke, Ischemic and Stroke Patients, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The aim of this randomised experimental study is to test the effect of different intensities of aerobic exercise on neurotrophin concentration and functional and cognitive functions in post-stroke patients undertaking a single bout and 3-week exercise programme. The main questions to answer are: 1. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stroke, Ischemic, Stroke Patients
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2021to 30 Dec 2021
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 21-75 years,
- first episode of ischemic stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT),
- able to walk for 4 m at a self-selected speed independently or with an assistive device (as needed),
- be in a stable clinical condition,
- able to communicate with investigators,
- provided written informed consent to participate in the study.
Who cannot join
- aphasia,
- an unstable cardiac status (e.g., evidence of significant arrhythmia or myocardial ischaemia),
- lower extremity claudication,
- weight-bearing pain >4/10,
- lower extremity spasticity (i.e., an Ashworth Scale score >2), other neurological conditions in addition to stroke,
- chronic degenerative or inflammatory diagnoses, malignancies, and visuospatial neglect.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Endurance Training on Exercise Tolerance, Motor Abilities, Cognitive Functions and Concentration of Selected Blood Biomarkers in Post-stroke Patients
The aim of this randomised experimental study is to test the effect of different intensities of aerobic exercise on neurotrophin concentration and functional and cognitive functions in post-stroke patients undertaking a single bout and 3-week exercise programme. The main questions to answer are:
- What is effect of different intensities of aerobic exercise on functional abilities in post-stroke patients undertaking a 3-week aerobic exercise programme?
- What is effect of different intensities of aerobic exercise on cognitive functions in post-stroke patients undertaking a 3-week aerobic exercise programme?
- What is effect of different intensities of aerobic exercise on neurotrophin concentration in post-stroke patients undertaking a 3-week aerobic exercise programme?
- What is effect of different intensities of 45-min single bout aerobic exercise on neurotrophin concentration in post-stroke patients?
Read more
The participants were randomly assigned to one of two groups: moderate-intensity continuous training on a bicycle ergometer and standard neurorehabilitation or low-intensity continuous training on a bicycle ergometer and standard neurorehabilitation. Training on a bicycle ergometer was performed four times a week for 45 min for 3 weeks. Each participant attended individual neurorehabilitation sessions 11 times per week (2 physical therapy sessions from Monday to Friday for 45 min each and 1 session on Saturday for 45 min) during the 3-week intervention.
Participants will have pre-tests and post-tests:
- blood samples collection (to measure level of brain-derived neurotrophic factor, glial cell derived neurotrophic factor, insulin-like growth factor, vascular-endothelial growth factor, irisin),
- body mass index
- The Graded Cycling Test with Talk Test
- 6-Minute Walk Test
- Rivermead Motor Assessment
- Barthel Index
- Addenbrooke's Cognitive Examination
- Vo2max
- Beck Depression Inventory
Researchers will compare two groups - moderate intensity continuous group and low intensity continuous group to see if there is a modulating effect of different intensities of exercise in participants' outcomes.
- Conditions
- Stroke, Ischemic, Stroke Patients
- Being tested
- Exercise
- Keywords
- stroke, cognitive functions, neurotrophins, neurological rehabilitation
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Training on a bicycle ergometer was performed four times a week for 3 weeks for 45 min. The exercise intensity corresponded to 50%-60% of maximal oxygen uptake (VO2max).
ExerciseBehavioural
Training on a bicycle ergometer was performed four times a week for 3 weeks for 45 min. The exercise intensity corresponded to 70 - 80% of maximal oxygen uptake (VO2max).
| Study group | Role | What they receive |
|---|---|---|
| exercise low intensity | Active comparator | Not described Receives: Behavioral: Exercise |
| exercise moderate intensity | Experimental | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain-derived neurotrophic factor
Level of brain-derived neurotrophic factor in ng/ml
Measured: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
Glial cell derived neurotrophic factor
Level of glial cell derived neurotrophic factor in ng/ml
Measured: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
Insulin-like growth factor
Level of insulin-like growth factor in ng/ml
Measured: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
irisin
Level of irisin in ng/ml
Measured: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
Vascular-endothelial growth factor A
Level of Vascular-endothelial growth factor A in ng/ml
Measured: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
The Graded Cycling Test with Talk Test
Cardiorespiratory fitness assessment with the Graded Cycling Test with Talk Test assess submaximal exercise in Watt. Higher Watt means better outcome.
Measured: Before and after 3-week intervention
Vo2max
Physical performance assessment with Vo2max in mL/min/kg.
Measured: Before and after 3-week intervention
Six Minute Walk Test
The 6 minute walking test assesses functional capacity during continuous walking on a 12-m ward hallway for 6 min. The test measures the distance a patient walks in 6 min.
Measured: Before and after 3-week intervention
Rivermead Motor Assessment
Functional mobility among post-stroke patients was assessed with the Rivermead Motor Assessment, a performance-based measure in points. This later includes 38 items that cover three sections: gross function, leg and trunk and arm function. The total score ranges from 0 to 38 points. Higher scores indicate a higher degree of functional mobility.
Measured: Before and after 3-week intervention
Barthel Index
The Barthel Index is a scale that measures an individual's functional outcomes. It consists of 10 items that assess activities of daily living, functional mobility, and gait. The score ranges from 0 to 100 points. The higher the score, the greater the individual's ability to self-care
Measured: Before and after 3-week intervention
Addenbrooke's Cognitive Examination
Cognitive functions assessment with Addenbrooke's Cognitive Examination in points. Higher scores means better outcome.
Measured: Before and after 3-week intervention
Beck Depression Inventory
Depressive symptoms assessment with Beck Depression Inventory in points. Higher scores means worse outcome.
Measured: Before and after 3-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Jun 2021
- Primary completion20 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824116
- Sponsor's protocol ID
- 378/21
- Status last verified
- Jan 2025
- First submitted
- 7 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Endurance Training on Exercise Tolerance, Motor Abilities, Cognitive Functions and Concentration of Selected Blood Biomarkers in Post-stroke Patients
- ClinicalTrials.gov ID
- NCT06824116
- Acronym / sponsor ID
- 378/21
- Conditions
- Stroke, Ischemic, Stroke Patients
- Keywords
- stroke, cognitive functions, neurotrophins, neurological rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 13 Feb 2025 (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 randomised experimental study is to test the effect of different intensities of aerobic exercise on neurotrophin concentration and functional and cognitive functions in post-stroke patients undertaking a single bout and 3-week exercise programme. The main questions to answer are:
- What is effect of different intensities of aerobic exercise on functional abilities in post-stroke patients undertaking a 3-week aerobic exercise programme?
- What is effect of different intensities of aerobic exercise on cognitive functions in post-stroke patients undertaking a 3-week aerobic exercise programme?
- What is effect of different intensities of aerobic exercise on neurotrophin concentration in post-stroke patients undertaking a 3-week aerobic exercise programme?
- What is effect of different intensities of 45-min single bout aerobic exercise on neurotrophin concentration in post-stroke patients?
The participants were randomly assigned to one of two groups: moderate-intensity continuous training on a bicycle ergometer and standard neurorehabilitation or low-intensity continuous training on a bicycle ergometer and standard neurorehabilitation. Training on a bicycle ergometer was performed four times a week for 45 min for 3 weeks. Each participant attended individual neurorehabilitation sessions 11 times per week (2 physical therapy sessions from Monday to Friday for 45 min each and 1 session on Saturday for 45 min) during the 3-week intervention.
Participants will have pre-tests and post-tests:
- blood samples collection (to measure level of brain-derived neurotrophic factor, glial cell derived neurotrophic factor, insulin-like growth factor, vascular-endothelial growth factor, irisin),
- body mass index
- The Graded Cycling Test with Talk Test
- 6-Minute Walk Test
- Rivermead Motor Assessment
- Barthel Index
- Addenbrooke's Cognitive Examination
- Vo2max
- Beck Depression Inventory
Researchers will compare two groups - moderate intensity continuous group and low intensity continuous group to see if there is a modulating effect of different intensities of exercise in participants' outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise low intensity | Active comparator | Behavioral: Exercise |
| exercise moderate intensity | Experimental | Behavioral: Exercise |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 21-75 years,
- first episode of ischemic stroke confirmed by magnetic resonance imaging (MRI) or computed tomography (CT),
- able to walk for 4 m at a self-selected speed independently or with an assistive device (as needed),
- be in a stable clinical condition,
- able to communicate with investigators,
Key exclusion criteria (6 listed)
- aphasia,
- an unstable cardiac status (e.g., evidence of significant arrhythmia or myocardial ischaemia),
- lower extremity claudication,
- weight-bearing pain >4/10,
- lower extremity spasticity (i.e., an Ashworth Scale score >2), other neurological conditions in addition to stroke,
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 |
|---|---|---|
| ExerciseTraining on a bicycle ergometer was performed four times a week for 3 weeks for 45 min. The exercise intensity corresponded to 50%-60% of maximal oxygen uptake (VO2max). | Behavioural | exercise low intensity |
| ExerciseTraining on a bicycle ergometer was performed four times a week for 3 weeks for 45 min. The exercise intensity corresponded to 70 - 80% of maximal oxygen uptake (VO2max). | Behavioural | exercise moderate intensity |
Primary outcome
Brain-derived neurotrophic factor
Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
Level of brain-derived neurotrophic factor in ng/ml
Glial cell derived neurotrophic factor
Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
Level of glial cell derived neurotrophic factor in ng/ml
Insulin-like growth factor
Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
Level of insulin-like growth factor in ng/ml
irisin
Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
Level of irisin in ng/ml
Vascular-endothelial growth factor A
Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
Level of Vascular-endothelial growth factor A in ng/ml
The Graded Cycling Test with Talk Test
Time frame: Before and after 3-week intervention
Cardiorespiratory fitness assessment with the Graded Cycling Test with Talk Test assess submaximal exercise in Watt. Higher Watt means better outcome.
Vo2max
Time frame: Before and after 3-week intervention
Physical performance assessment with Vo2max in mL/min/kg.
Six Minute Walk Test
Time frame: Before and after 3-week intervention
The 6 minute walking test assesses functional capacity during continuous walking on a 12-m ward hallway for 6 min. The test measures the distance a patient walks in 6 min.
Rivermead Motor Assessment
Time frame: Before and after 3-week intervention
Functional mobility among post-stroke patients was assessed with the Rivermead Motor Assessment, a performance-based measure in points. This later includes 38 items that cover three sections: gross function, leg and trunk and arm function. The total score ranges from 0 to 38 points. Higher scores indicate a higher degree of functional mobility.
Barthel Index
Time frame: Before and after 3-week intervention
The Barthel Index is a scale that measures an individual's functional outcomes. It consists of 10 items that assess activities of daily living, functional mobility, and gait. The score ranges from 0 to 100 points. The higher the score, the greater the individual's ability to self-care
Addenbrooke's Cognitive Examination
Time frame: Before and after 3-week intervention
Cognitive functions assessment with Addenbrooke's Cognitive Examination in points. Higher scores means better outcome.
Beck Depression Inventory
Time frame: Before and after 3-week intervention
Depressive symptoms assessment with Beck Depression Inventory in points. Higher scores means worse outcome.
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 13 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Stroke, Ischemic and Stroke Patients, run by Poznan University of Physical Education at 1 site in Poland.
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 6 inclusion and 6 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 13 Feb 2025. 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 Poland. 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?
Brain-derived neurotrophic factor (time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention). The study lists 12 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 13 Feb 2025.