Effect of Exercise Gene Expression and Histone Modifications in Patients With Hemiplegia

NCT06726941 | Recruiting

• 1 other identifier: BBBEPIGENETIC
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to demonstrate the effect of routine exercise program on neuroplasticity through histone acetylation and gene expression changes in acute stroke survivors from an epigenetic perspective and to investigate the correlation of epigenetic effects with its effects on motor function and quality of life.

Conditions

Ischemic Stroke, Acute; Acute Hemiparesis

Keywords

ischemic stroke; acute hemiplegia; epigenetics

Outcome Measures

Primary Outcomes (3)

• Genetic analyses

  Real-Time Polymerase Chain Reaction (PCR) method will be used to determine the expression of BDNF, CREB1, GAP43, NTRK2 and SYN1 genes from the peripheral venous blood samples of the participants. The region of interest will be amplified in the Real-Time PCR device using primer pairs specific to the relevant genes. Changes in gene expressions in patients before and after treatment will be determined.

  Baseline (pre-treatment) and 6 weeks (post-treatment)

• Histone Proteins

  Leukocytes will be isolated from blood samples before and after exercise. Isolation of histone proteins will be performed from the isolated leukocytes using the relevant isolation procedures. Pre- and post-treatment levels will be compared.

  Baseline (pre-treatment) and 6 weeks (post-treatment)

• Histone Acetylation Analysis

  H3K27ac levels in the isolated histone proteins will be determined colorimetrically based on the ELISA method. Pre- and post-treatment levels will be compared.

  Baseline (pre-treatment) and 6 weeks (post-treatment)

Secondary Outcomes (7)

• Neurophysiological Assessment

  Baseline (pre-treatment) and 6 weeks (post-treatment)

• Spasticity Assessment

  Baseline (pre-treatment) and 6 weeks (post-treatment)

• Functional independence scale (FIM)

  Baseline (pre-treatment) and 6 weeks (post-treatment)

• Fugl Meyer Upper Extremity Evaluation Questionnaire

  Baseline (pre-treatment) and 6 weeks (post-treatment)

• A Rasch-built measure of manual ability(ABILHAND) Stroke Hand Function Questionnaire

  Baseline (pre-treatment) and 6 weeks (post-treatment)

Study Arms (1)

Experimental Group

EXPERIMENTAL

This group consists of post-stroke hemiplegia participants who will be included in a physiotherapy and rehabilitation program to evaluate the effects on neuroplasticity-related gene expression and histone modification levels, spasticity levels, motor functions, daily living activities, and quality of life.

Other: Physiotherapy and Rehabilitation Practices

Interventions

Physiotherapy and Rehabilitation Practices OTHER

It was planned to give the participants a routine stroke rehabilitation program consisting of 45 minutes of active, passive range of motion exercises and strengthening exercises, balance exercises, walking training and 20 minutes of bicycle ergometry, accompanied by a physiotherapist with at least 5 years of experience in stroke rehabilitation. It was planned to give passive bicycle ergometry to patients without voluntary muscle movement and muscle strength, and active bicycle ergometry to participants with voluntary muscle movement and muscle strength, with the bicycle rehabilitation. It was planned to apply the exercise program to the patients for 5 days a week and for a total of 30 sessions. It will be recommended that they continue the medical treatment they are using during the treatment program. Routine evaluations will be made by the physiatrist before the rehabilitation program starts and 2 tubes of venous blood will be taken from the patients by an experienced nurse

Experimental Group

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who applied to Afyonkarahisar Health Sciences University Physical Therapy and Rehabilitation Clinic for rehabilitation purposes and had a stroke for the first time
• Participants with ischemia as the etiology of stroke
• Participants between the ages of 25-70
• Drugs that have been used for at least 1 month and up to 6 months after a cerebrovascular accident

You may not qualify if:

• Participants whose stroke etiology is other than ischemia
• Participants with clinically significant neurological disease other than stroke
• Participants with systemic and musculoskeletal diseases that will not tolerate neurological rehabilitation and prevent them from participating

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 0300, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Xing Y, Bai Y. A Review of Exercise-Induced Neuroplasticity in Ischemic Stroke: Pathology and Mechanisms. Mol Neurobiol. 2020 Oct;57(10):4218-4231. doi: 10.1007/s12035-020-02021-1. Epub 2020 Jul 20.

  PMID: 32691303 BACKGROUND

• Maejima H, Kitahara M, Takamatsu Y, Mani H, Inoue T. Effects of exercise and pharmacological inhibition of histone deacetylases (HDACs) on epigenetic regulations and gene expressions crucial for neuronal plasticity in the motor cortex. Brain Res. 2021 Jan 15;1751:147191. doi: 10.1016/j.brainres.2020.147191. Epub 2020 Nov 2.

  PMID: 33152341 BACKGROUND

• Penna LG, Pinheiro JP, Ramalho SHR, Ribeiro CF. Effects of aerobic physical exercise on neuroplasticity after stroke: systematic review. Arq Neuropsiquiatr. 2021 Sep;79(9):832-843. doi: 10.1590/0004-282X-ANP-2020-0551.

  PMID: 34669820 BACKGROUND

Related Links

• A Review of Exercise-Induced Neuroplasticity in Ischemic Stroke.
• Effects of exercise and pharmacological inhibition of histone deacetylases (HDACs) on epigenetic regulations and gene expressions crucial for neuronal plasticity in the motor cortex.
• Effects of aerobic physical exercise on neuroplasticity after stroke.

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Hasan Toktas, Professor

  Afyonkarahisar Health Sciences University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hasan Toktaş, Professor

CONTACT

+905052212901; hasantoktas@yahoo.com

Büşra B Kurt, M.D.

CONTACT

+905447289558; busrabetulbocek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All participants enrolled will receive the same treatment. Gene analysis, histone acetylation levels, motor function and quality of life changes will be assessed.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): June 9, 2026
• Study Completion (Estimated): September 9, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

TU (1)