Yoga and Aerobic Exercise in Epilepsy

Not Applicable

Completed

• Conditions: Epilepsy; Seizure; Epilepsy Idiopathic; Epilepsy
• Interventions: Other: Exercise training

• Registration Number: NCT05066880
• Lead Sponsor: Dokuz Eylul University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-23
• Study First Submitted QC: 2021-09-23
• Study First Posted: 2021-10-04
• Study Start: 2021-10-07
• Status Verified: 2022-12
• Primary Completion: 2024-01-01
• Study Completion: 2024-05-01
• Last Update Submitted: 2024-05-15
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Yoga	Exercise training	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.
Aerobic exercise	Exercise training	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dokuz Eylul University; 🇹🇷 Izmir, Turkey