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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05066880
Other study ID # 5258-GOA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2021
Est. completion date May 1, 2024

Study information

Verified date December 2022
Source Dokuz Eylul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In recent years, there is growing interest in illustrating the health benefits of exercise among epilepsy. Although exercise is recommended for patients with epilepsy, there is uncertainty concerning the effects of yoga and aerobic exercise on multiple health outcomes in epilepsy. The aim of this trial is to examine the effects of yoga and aerobic exercise training on physical activity, health-related physical fitness, mental, emotional, and psychological health status, seizure frequency and quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients with epilepsy diagnosed by a neurologist using the International League Against Epilepsy (ILAE) criteria, - Having access to the internet at least three per week. Exclusion Criteria: - Any history of neurological disorders other than epilepsy, - Significant physical and cognitive impairments, - Musculoskeletal comorbid conditions, - Contraindications for an exercise intervention including diagnosed cardiovascular, pulmonary, or endocrine diseases, - Pregnancy, - Mental deficiency or low education level to understand the questionnaires, - Currently participating in an exercise program, - Volunteers who miss 3 consecutive intervention sessions, and do not participate in 10% of sessions.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise training
Exercise training for 8 weeks

Locations

Country Name City State
Turkey Dokuz Eylul University Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical activity in daily life Physical activity will be objectively monitored with an accelerometer. change from baseline to 8 weeks
Primary Seizure Participants will be given a seizure diary and requested to record the number of their seizure. change from baseline to 8 weeks
Secondary Six-Minute Walk test The Six-Minute Walk test will be used to determine functional capacity. change from baseline to 8 weeks
Secondary 30-second Chair Stand test Lower body strength will be determined using the 30-second Chair Stand test. change from baseline to 8 weeks
Secondary Biodex Balance System Balance evaluation will be performed with Biodex Balance System. change from baseline to 8 weeks
Secondary Bioelectrical impedance analyzer Body composition measurements will be performed with bioelectrical impedance analyzer. change from baseline to 8 weeks
Secondary Waist and hip circumference For the anthropometric measurements, waist and hip circumference will be taken. change from baseline to 8 weeks
Secondary Trail Making test and Digit Span test The Trail Making test and Digit Span test will be used to evaluate for attention. change from baseline to 8 weeks
Secondary Stroop test and Verbal Fluency The Stroop test and Verbal Fluency will be used to evaluate for executive functions. change from baseline to 8 weeks
Secondary Weschler Memory Scale-Revised Visual Reproduction subtest The Weschler Memory Scale-Revised Visual Reproduction subtest will be used to evaluate for visual memory. change from baseline to 8 weeks
Secondary Clock Drawing test The Clock Drawing test will be used to evaluate for visual perception and visual-spatial functions. change from baseline to 8 weeks
Secondary Oktem Verbal Memory Processes test The Oktem Verbal Memory Processes test will be used to evaluate for verbal memory performance. change from baseline to 8 weeks
Secondary Neurological Disorders Depression Inventory for Epilepsy The Neurological Disorders Depression Inventory for Epilepsy will be used to evaluate for depression. change from baseline to 8 weeks
Secondary Generalized Anxiety Disorder-7 Anxiety will be determined by the Generalized Anxiety Disorder-7. change from baseline to 8 weeks
Secondary 10-item Perceived Stress Scale The 10-item Perceived Stress Scale will be used to assess subjective stress. change from baseline to 8 weeks
Secondary Fatigue Impact Scale Fatigue will be assessed with the Fatigue Impact Scale. change from baseline to 8 weeks
Secondary Pittsburg Sleep Quality Index Sleep quality will be measured using the Pittsburg Sleep Quality Index. change from baseline to 8 weeks
Secondary Quality of Life in Epilepsy Inventory-31 It will be used to determine health-related quality of life for epilepsy. change from baseline to 8 weeks
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