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Completed

NCT Number: NCT05066880

Yoga and Aerobic Exercise in 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.

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Key information

Conditions

Epilepsy Behavior Brain Diseases Central Nervous System Diseases Epilepsy Idiopathic Epilepsy; Seizure Motor Activity Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dokuz Eylul University

Izmir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise training

Other

Exercise training for 8 weeks

Primary outcomes

  1. Physical activity in daily life

    Time frame: change from baseline to 8 weeks

    Physical activity will be objectively monitored with an accelerometer.

  2. Seizure

    Time frame: change from baseline to 8 weeks

    Participants will be given a seizure diary and requested to record the number of their seizure.

Secondary outcomes

  1. Six-Minute Walk test

    Time frame: change from baseline to 8 weeks

    The Six-Minute Walk test will be used to determine functional capacity.

  2. 30-second Chair Stand test

    Time frame: change from baseline to 8 weeks

    Lower body strength will be determined using the 30-second Chair Stand test.

  3. Biodex Balance System

    Time frame: change from baseline to 8 weeks

    Balance evaluation will be performed with Biodex Balance System.

  4. Bioelectrical impedance analyzer

    Time frame: change from baseline to 8 weeks

    Body composition measurements will be performed with bioelectrical impedance analyzer.

  5. Waist and hip circumference

    Time frame: change from baseline to 8 weeks

    For the anthropometric measurements, waist and hip circumference will be taken.

  6. Trail Making test and Digit Span test

    Time frame: change from baseline to 8 weeks

    The Trail Making test and Digit Span test will be used to evaluate for attention.

  7. Stroop test and Verbal Fluency

    Time frame: change from baseline to 8 weeks

    The Stroop test and Verbal Fluency will be used to evaluate for executive functions.

  8. Weschler Memory Scale-Revised Visual Reproduction subtest

    Time frame: change from baseline to 8 weeks

    The Weschler Memory Scale-Revised Visual Reproduction subtest will be used to evaluate for visual memory.

  9. Clock Drawing test

    Time frame: change from baseline to 8 weeks

    The Clock Drawing test will be used to evaluate for visual perception and visual-spatial functions.

  10. Oktem Verbal Memory Processes test

    Time frame: change from baseline to 8 weeks

    The Oktem Verbal Memory Processes test will be used to evaluate for verbal memory performance.

  11. Neurological Disorders Depression Inventory for Epilepsy

    Time frame: change from baseline to 8 weeks

    The Neurological Disorders Depression Inventory for Epilepsy will be used to evaluate for depression.

  12. Generalized Anxiety Disorder-7

    Time frame: change from baseline to 8 weeks

    Anxiety will be determined by the Generalized Anxiety Disorder-7.

  13. 10-item Perceived Stress Scale

    Time frame: change from baseline to 8 weeks

    The 10-item Perceived Stress Scale will be used to assess subjective stress.

  14. Fatigue Impact Scale

    Time frame: change from baseline to 8 weeks

    Fatigue will be assessed with the Fatigue Impact Scale.

  15. Pittsburg Sleep Quality Index

    Time frame: change from baseline to 8 weeks

    Sleep quality will be measured using the Pittsburg Sleep Quality Index.

  16. Quality of Life in Epilepsy Inventory-31

    Time frame: change from baseline to 8 weeks

    It will be used to determine health-related quality of life for epilepsy.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 4, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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