Yoga and Aerobic Exercise in Epilepsy

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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Epilepsy; Seizure; Epilepsy Idiopathic
• Intervention / Treatment: Other: Exercise training

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey
    • Dokuz Eylül University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yoga; 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; Exercise training for 8 weeks
Experimental: Aerobic exercise; 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; Exercise training for 8 weeks
No Intervention: Wait-list; 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?

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

Collaborators and Investigators

• Sponsor: Dokuz Eylul University

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2021
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: exercise; epilepsy; yoga; aerobic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: 5258-GOA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No