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Yoga and Aerobic Exercise in Epilepsy

Primary Purpose

Epilepsy, Epilepsy; Seizure, Epilepsy Idiopathic

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise training
Sponsored by
Dokuz Eylul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring epilepsy, yoga, aerobic, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dokuz Eylul UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Yoga

Aerobic exercise

Wait-list

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Physical activity in daily life
Physical activity will be objectively monitored with an accelerometer.
Seizure
Participants will be given a seizure diary and requested to record the number of their seizure.

Secondary Outcome Measures

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

Full Information

First Posted
September 23, 2021
Last Updated
October 25, 2021
Sponsor
Dokuz Eylul University
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1. Study Identification

Unique Protocol Identification Number
NCT05066880
Brief Title
Yoga and Aerobic Exercise in Epilepsy
Official Title
Investigation of the Effects of Yoga and Aerobic Exercise Training on Physical and Mental Health in People With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Epilepsy; Seizure, Epilepsy Idiopathic
Keywords
epilepsy, yoga, aerobic, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerobic exercise
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Exercise training for 8 weeks
Primary Outcome Measure Information:
Title
Physical activity in daily life
Description
Physical activity will be objectively monitored with an accelerometer.
Time Frame
change from baseline to 8 weeks
Title
Seizure
Description
Participants will be given a seizure diary and requested to record the number of their seizure.
Time Frame
change from baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Six-Minute Walk test
Description
The Six-Minute Walk test will be used to determine functional capacity.
Time Frame
change from baseline to 8 weeks
Title
30-second Chair Stand test
Description
Lower body strength will be determined using the 30-second Chair Stand test.
Time Frame
change from baseline to 8 weeks
Title
Biodex Balance System
Description
Balance evaluation will be performed with Biodex Balance System.
Time Frame
change from baseline to 8 weeks
Title
Bioelectrical impedance analyzer
Description
Body composition measurements will be performed with bioelectrical impedance analyzer.
Time Frame
change from baseline to 8 weeks
Title
Waist and hip circumference
Description
For the anthropometric measurements, waist and hip circumference will be taken.
Time Frame
change from baseline to 8 weeks
Title
Trail Making test and Digit Span test
Description
The Trail Making test and Digit Span test will be used to evaluate for attention.
Time Frame
change from baseline to 8 weeks
Title
Stroop test and Verbal Fluency
Description
The Stroop test and Verbal Fluency will be used to evaluate for executive functions.
Time Frame
change from baseline to 8 weeks
Title
Weschler Memory Scale-Revised Visual Reproduction subtest
Description
The Weschler Memory Scale-Revised Visual Reproduction subtest will be used to evaluate for visual memory.
Time Frame
change from baseline to 8 weeks
Title
Clock Drawing test
Description
The Clock Drawing test will be used to evaluate for visual perception and visual-spatial functions.
Time Frame
change from baseline to 8 weeks
Title
Oktem Verbal Memory Processes test
Description
The Oktem Verbal Memory Processes test will be used to evaluate for verbal memory performance.
Time Frame
change from baseline to 8 weeks
Title
Neurological Disorders Depression Inventory for Epilepsy
Description
The Neurological Disorders Depression Inventory for Epilepsy will be used to evaluate for depression.
Time Frame
change from baseline to 8 weeks
Title
Generalized Anxiety Disorder-7
Description
Anxiety will be determined by the Generalized Anxiety Disorder-7.
Time Frame
change from baseline to 8 weeks
Title
10-item Perceived Stress Scale
Description
The 10-item Perceived Stress Scale will be used to assess subjective stress.
Time Frame
change from baseline to 8 weeks
Title
Fatigue Impact Scale
Description
Fatigue will be assessed with the Fatigue Impact Scale.
Time Frame
change from baseline to 8 weeks
Title
Pittsburg Sleep Quality Index
Description
Sleep quality will be measured using the Pittsburg Sleep Quality Index.
Time Frame
change from baseline to 8 weeks
Title
Quality of Life in Epilepsy Inventory-31
Description
It will be used to determine health-related quality of life for epilepsy.
Time Frame
change from baseline to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burcin Aktar, MSc
Phone
+905549350857
Email
burcinaktar@gmail.com
Facility Information:
Facility Name
Dokuz Eylul University
City
Izmir
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burcin Aktar, MSc
Phone
+905549350857
Email
burcinaktar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Yoga and Aerobic Exercise in Epilepsy

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