Yoga and Aerobic Exercise in Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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Investigation of the Effects of Yoga and Aerobic Exercise Training on Physical and Mental Health in People With Epilepsy

Conditions
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Epilepsy, Epilepsy; Seizure, Epilepsy Idiopathic

Intervention / Treatment
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* Other: Exercise training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga<br>Participants allocated to the yoga group will receive the yoga-based intervention through an internet-based video conference remotely in real-time. Each class will accommodate a maximum of 5 subjects. A qualified physiotherapist who was a certificated yoga instructor will teach in these classrooms. The 8-week exercise intervention consists of three times per week sessions of yoga. | Other: Exercise training<br>* Exercise training for 8 weeks<br>|
| Experimental: Aerobic exercise<br>Participants of the aerobic exercise group will be requested to perform unsupervised aerobic training in the home environment (e.g., at home, park, backyard, or in the local gym). The 8-week exercise intervention consists of three times per week sessions of aerobic exercise. Training will consist of a 10-min warm-up period, aerobic activity, and 5-min cool-down period. | Other: Exercise training<br>* Exercise training for 8 weeks<br>|
| No Intervention: Wait-list<br>Participants in the wait-list group will be advised to continue their habitual physical activity next to usual medical care. A yoga or aerobic exercise program of 8 weeks will be offered after the ending of the study period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity in daily life | Physical activity will be objectively monitored with an accelerometer. | change from baseline to 8 weeks | 
| Seizure | Participants will be given a seizure diary and requested to record the number of their seizure. | change from baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-Minute Walk test | The Six-Minute Walk test will be used to determine functional capacity. | change from baseline to 8 weeks | 
| 30-second Chair Stand test | Lower body strength will be determined using the 30-second Chair Stand test. | change from baseline to 8 weeks | 
| Biodex Balance System | Balance evaluation will be performed with Biodex Balance System. | change from baseline to 8 weeks | 
| Bioelectrical impedance analyzer | Body composition measurements will be performed with bioelectrical impedance analyzer. | change from baseline to 8 weeks | 
| Waist and hip circumference | For the anthropometric measurements, waist and hip circumference will be taken. | change from baseline to 8 weeks | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Generalized Anxiety Disorder-7 | Anxiety will be determined by the Generalized Anxiety Disorder-7. | change from baseline to 8 weeks | 
| 10-item Perceived Stress Scale | The 10-item Perceived Stress Scale will be used to assess subjective stress. | change from baseline to 8 weeks | 
| Fatigue Impact Scale | Fatigue will be assessed with the Fatigue Impact Scale. | change from baseline to 8 weeks | 
| Pittsburg Sleep Quality Index | Sleep quality will be measured using the Pittsburg Sleep Quality Index. | change from baseline to 8 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epilepsy, yoga, aerobic, exercise