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NCT Number: NCT06824116

The Effect of Endurance Training on Motor and Cognitive Functions and Concentration of 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:

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Stroke Patients Vascular Diseases

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiology

Poznan, 61-871, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise

Behavioral

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).

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.

  7. Vo2max

    Time frame: Before and after 3-week intervention

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

  8. 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.

  9. 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.

  10. 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

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Poznan University of Physical Education

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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