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CompletedNCT06824116Updated Feb 13, 2025

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

An interventional study of Exercise and Exercise in Stroke, Ischemic and Stroke Patients, sponsored by Poznan University of Physical Education. Completed at 1 site in Poland. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Poznan University of Physical Education · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 3 years 8 months after the study started (first participant enrolled Jun 2021, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke, Ischemic
  • Stroke Patients

Keywords

  • stroke
  • cognitive functions
  • neurotrophins
  • neurological rehabilitation
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 44 is below the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Poznan University of Physical Education is the lead sponsor of 90 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    exercise low intensity

    Behavioral: Exercise

  • Experimental
    exercise moderate intensity

    Behavioral: Exercise

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).

  • BehavioralExercise

    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).

06

What researchers measure

Primary outcomes

  1. Brain-derived neurotrophic factor

    Level of brain-derived neurotrophic factor in ng/ml

    Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention

  2. Glial cell derived neurotrophic factor

    Level of glial cell derived neurotrophic factor in ng/ml

    Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention

  3. Insulin-like growth factor

    Level of insulin-like growth factor in ng/ml

    Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention

  4. irisin

    Level of irisin in ng/ml

    Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention

  5. Vascular-endothelial growth factor A

    Level of Vascular-endothelial growth factor A in ng/ml

    Time frame: Before and after 3-week intervention; pre and post single bout of exercise in the first day of intervention

  6. 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.

    Time frame: Before and after 3-week intervention

  7. Vo2max

    Physical performance assessment with Vo2max in mL/min/kg.

    Time frame: Before and after 3-week intervention

  8. 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.

    Time frame: Before and after 3-week intervention

  9. 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.

    Time frame: Before and after 3-week intervention

  10. 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

    Time frame: Before and after 3-week intervention

  11. Addenbrooke's Cognitive Examination

    Cognitive functions assessment with Addenbrooke's Cognitive Examination in points. Higher scores means better outcome.

    Time frame: Before and after 3-week intervention

  12. Beck Depression Inventory

    Depressive symptoms assessment with Beck Depression Inventory in points. Higher scores means worse outcome.

    Time frame: Before and after 3-week intervention

07

Study locations

1 site
  • Department of Physiology
    Poznań, 61-871, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06824116
Lead sponsor
Poznan University of Physical Education
Responsible party
Sponsor
First posted
Feb 13, 2025
Start date
Jun 1, 2021
Primary completion
Dec 20, 2021
Completion
Dec 30, 2021
Last update
Feb 13, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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