Effect of Exercise Gene Expression and Histone Modifications in Patients With Hemiplegia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-70
SponsorAfyonkarahisar Health Sciences University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Physiotherapy and Rehabilitation Practices
Other interventionIt 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
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Experimental GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (pre-treatment) and 6 weeks (post-treatment)2
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.
Time frame
Baseline (pre-treatment) and 6 weeks (post-treatment)3
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.
Time frame
Baseline (pre-treatment) and 6 weeks (post-treatment)Secondary outcomes
1
Neurophysiological Assessment
Brunnstrom Staging is a test that evaluates the motor development of hemiplegic patients. In this test, the neurophysiological recovery process of hemiplegic patients is defined as 6 stages. According to this staging, the lowest stage is stage 1 (flaccid, no voluntary movement stage), and the highest stage is stage 6 (isolated joint movement stage). In Brunnstrom staging, the hand, upper extremity and lower extremity are evaluated separately.
Time frame
Baseline (pre-treatment) and 6 weeks (post-treatment)2
Spasticity Assessment
Spasticity was planned to be evaluated with the Modified Ashworth Scale (MAS). In MAS, patients are evaluated over 5 points. 0 indicates no increase in muscle tone, and 4 indicates that the extremity is rigid in the flexion and extension directions.
Time frame
Baseline (pre-treatment) and 6 weeks (post-treatment)3
Functional independence scale (FIM)
It is a widely applied, validated and reliable approach to functional assessment in Turkish society. FIM analyzes two different aspects of disability, namely motor and cognitive functions. FIM is a scale consisting of 6 subgroups, namely self-care (42 points), sphincter control (14 points), transfer (21 points), movement (14 points), communication (14 points) and social perception (21 points), and evaluates 18 activities. Each activity is evaluated in terms of functional independence using a 7-point scale. Higher scores indicates independence.
Time frame
Baseline (pre-treatment) and 6 weeks (post-treatment)4
Fugl Meyer Upper Extremity Evaluation Questionnaire
The Fugl-Meyer Upper Extremity Motor Evaluation Questionnaire (FMUE Questionnaire) was developed to quantitatively assess sensorimotor recovery after stroke. It was prepared based on Brunnstrom's stages of motor recovery. The FMUE Questionnaire consists of 33 items, each scored from 0 to 2, where 0 = cannot perform, 1 = partially performs, and 2 = fully performs. The total score is 66. A range of data is available for the FMUE Questionnaire for clinically important minimum differences. A change of 4 to 7 points in chronic stroke and 9 to 10 points in subacute stroke is considered clinically significant.
Time frame
Baseline (pre-treatment) and 6 weeks (post-treatment)Sponsors and contacts
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Source ClinicalTrials.gov