Yoga and Aerobic Exercise in Epilepsy

Sponsor
Dokuz Eylul University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05066880
Collaborator
(none)
51
1
3
35
1.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
51 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effects of Yoga and Aerobic Exercise Training on Physical and Mental Health in People With Epilepsy
Anticipated Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Physical activity in daily life [change from baseline to 8 weeks]

    Physical activity will be objectively monitored with an accelerometer.

  2. 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

  1. Six-Minute Walk test [change from baseline to 8 weeks]

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

  2. 30-second Chair Stand test [change from baseline to 8 weeks]

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

  3. Biodex Balance System [change from baseline to 8 weeks]

    Balance evaluation will be performed with Biodex Balance System.

  4. Bioelectrical impedance analyzer [change from baseline to 8 weeks]

    Body composition measurements will be performed with bioelectrical impedance analyzer.

  5. Waist and hip circumference [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 [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 [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 [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 [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 [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 [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 [change from baseline to 8 weeks]

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

  13. 10-item Perceived Stress Scale [change from baseline to 8 weeks]

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

  14. Fatigue Impact Scale [change from baseline to 8 weeks]

    Fatigue will be assessed with the Fatigue Impact Scale.

  15. Pittsburg Sleep Quality Index [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 [change from baseline to 8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dokuz Eylul University Izmir Turkey

Sponsors and Collaborators

  • Dokuz Eylul University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Burcin Aktar, Institute of Health Sciences, Dokuz Eylul University
ClinicalTrials.gov Identifier:
NCT05066880
Other Study ID Numbers:
  • 5258-GOA
First Posted:
Oct 4, 2021
Last Update Posted:
Nov 1, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Burcin Aktar, Institute of Health Sciences, Dokuz Eylul University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 1, 2021