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

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.

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic; Stroke Patients
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Poznań, Poland, 61-871
    • Department of Physiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: exercise low intensity	Behavioral: Exercise; 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).; Behavioral: Exercise; 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).
Experimental: exercise moderate intensity	Behavioral: Exercise; 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).; Behavioral: Exercise; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain-derived neurotrophic factor	Level of brain-derived neurotrophic factor in ng/ml	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	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	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	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	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.	Before and after 3-week intervention
Vo2max	Physical performance assessment with Vo2max in mL/min/kg.	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.	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.	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	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.	Before and after 3-week intervention
Beck Depression Inventory	Depressive symptoms assessment with Beck Depression Inventory in points. Higher scores means worse outcome.	Before and after 3-week intervention

Collaborators and Investigators

• Sponsor: Poznan University of Physical Education

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: February 7, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: stroke; neurological rehabilitation; cognitive functions; neurotrophins
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Ischemic Stroke; Stroke
• Other Study ID Numbers: 378/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No