Yoga and Aerobic Exercise in Epilepsy

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05066880
• Other study ID #: 5258-GOA
• Status: Recruiting
• Phase: N/A
• Start date: October 7, 2021
• Est. completion date: September 1, 2024

Study information

• Verified date: December 2022
• Source: Dokuz Eylul University
• Contact: Burcin Aktar, MSc
• Phone: +905549350857
• Email: burcinaktar[@]gmail.com
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 51
• Est. completion date: September 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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy Idiopathic
• Epilepsy; Seizure
• Seizures

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