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The Effect of Endurance Training on Motor and Cognitive Functions and Concentration of Biomarkers in Post-stroke Patients

The Effect of Endurance Training on Exercise Tolerance, Motor Abilities, Cognitive Functions and Concentration of Selected Blood Biomarkers in Post-stroke Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06824116
Enrollment
44
Registered
2025-02-13
Start date
2021-06-01
Completion date
2021-12-30
Last updated
2025-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Ischemic, Stroke Patients

Keywords

stroke, cognitive functions, neurotrophins, neurological rehabilitation

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.

Interventions

BEHAVIORALExercise

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).

Sponsors

Poznan University of Physical Education
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Brain-derived neurotrophic factorBefore and after 3-week intervention; pre and post single bout of exercise in the first day of interventionLevel of brain-derived neurotrophic factor in ng/ml
Glial cell derived neurotrophic factorBefore and after 3-week intervention; pre and post single bout of exercise in the first day of interventionLevel of glial cell derived neurotrophic factor in ng/ml
Insulin-like growth factorBefore and after 3-week intervention; pre and post single bout of exercise in the first day of interventionLevel of insulin-like growth factor in ng/ml
irisinBefore and after 3-week intervention; pre and post single bout of exercise in the first day of interventionLevel of irisin in ng/ml
Vascular-endothelial growth factor ABefore and after 3-week intervention; pre and post single bout of exercise in the first day of interventionLevel of Vascular-endothelial growth factor A in ng/ml
The Graded Cycling Test with Talk TestBefore and after 3-week interventionCardiorespiratory fitness assessment with the Graded Cycling Test with Talk Test assess submaximal exercise in Watt. Higher Watt means better outcome.
Vo2maxBefore and after 3-week interventionPhysical performance assessment with Vo2max in mL/min/kg.
Six Minute Walk TestBefore and after 3-week interventionThe 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 AssessmentBefore and after 3-week interventionFunctional 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 IndexBefore and after 3-week interventionThe 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 ExaminationBefore and after 3-week interventionCognitive functions assessment with Addenbrooke's Cognitive Examination in points. Higher scores means better outcome.
Beck Depression InventoryBefore and after 3-week interventionDepressive symptoms assessment with Beck Depression Inventory in points. Higher scores means worse outcome.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026