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

NCT ID: NCT06824116

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2021-12-30

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.

Conditions

Stroke, Ischemic; Stroke Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

exercise low intensity

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: 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 moderate intensity

Group Type: EXPERIMENTAL

Exercise

Intervention Type: BEHAVIORAL

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).

Interventions

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).

Intervention Type: 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poznan University of Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Physiology

Poznan, , Poland

Countries

Poland

Other Identifiers

378/21

Identifier Type: -

Identifier Source: org_study_id