Clinical trial NCT06824116: The Effect of Endurance Training on Motor and Cognitive Functions and Concentration of Biomarkers in Post-stroke Patients
Official title: The Effect of Endurance Training on Exercise Tolerance, Motor Abilities, Cognitive Functions and Concentration of Selected Blood Biomarkers in Post-stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke Patients
Keywords: stroke
cognitive functions
neurotrophins
neurological rehabilitation
Lead sponsor: Poznan University of Physical Education
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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. What is effect of different intensities of aerobic exercise on functional abilities in post-stroke patients undertaking a 3-week aerobic exercise programme?
2. What is effect of different intensities of aerobic exercise on cognitive functions in post-stroke patients undertaking a 3-week aerobic exercise programme?
3. What is effect of different intensities of aerobic exercise on neurotrophin concentration in post-stroke patients undertaking a 3-week aerobic exercise programme?
4. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Brain-derived neurotrophic factor
timeFrame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
measure: Glial cell derived neurotrophic factor
timeFrame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
measure: Insulin-like growth factor
timeFrame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
measure: irisin
timeFrame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
measure: Vascular-endothelial growth factor A
timeFrame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention
measure: The Graded Cycling Test with Talk Test
timeFrame: Before and after 3-week intervention
measure: Vo2max
timeFrame: Before and after 3-week intervention
measure: Six Minute Walk Test
timeFrame: Before and after 3-week intervention
measure: Rivermead Motor Assessment
timeFrame: Before and after 3-week intervention
measure: Barthel Index
timeFrame: Before and after 3-week intervention
measure: Addenbrooke's Cognitive Examination
timeFrame: Before and after 3-week intervention
measure: Beck Depression Inventory
timeFrame: Before and after 3-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Physiology
Study officials:
References: