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

NCT06824116 | Completed

• 1 other identifier: 378/21
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Stroke, Ischemic; Stroke Patients

Keywords

stroke; cognitive functions; neurotrophins; neurological rehabilitation

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

exercise low intensity

ACTIVE COMPARATOR

Behavioral: Exercise

exercise moderate intensity

EXPERIMENTAL

Behavioral: Exercise

Interventions

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).

exercise low intensity

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Poznan University of Physical Education: lead

Study Sites (1)

Department of Physiology

Poznan, 61-871, Poland

Location

MeSH Terms

Conditions

Ischemic Stroke; Stroke

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: June 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 30, 2021
• Last Updated: February 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)