Yoga and Aerobic Exercise in Epilepsy

May 15, 2024 updated by: Burcin Aktar, Dokuz Eylul University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Izmir, Turkey
        • Dokuz Eylül University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Physical activity in daily life
Time Frame: change from baseline to 8 weeks
Physical activity will be objectively monitored with an accelerometer.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Six-Minute Walk test
Time Frame: change from baseline to 8 weeks
The Six-Minute Walk test will be used to determine functional capacity.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks
Biodex Balance System
Time Frame: change from baseline to 8 weeks
Balance evaluation will be performed with Biodex Balance System.
change from baseline to 8 weeks
Bioelectrical impedance analyzer
Time Frame: change from baseline to 8 weeks
Body composition measurements will be performed with bioelectrical impedance analyzer.
change from baseline to 8 weeks
Waist and hip circumference
Time Frame: change from baseline to 8 weeks
For the anthropometric measurements, waist and hip circumference will be taken.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks
Generalized Anxiety Disorder-7
Time Frame: change from baseline to 8 weeks
Anxiety will be determined by the Generalized Anxiety Disorder-7.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks
Fatigue Impact Scale
Time Frame: change from baseline to 8 weeks
Fatigue will be assessed with the Fatigue Impact Scale.
change from baseline to 8 weeks
Pittsburg Sleep Quality Index
Time Frame: change from baseline to 8 weeks
Sleep quality will be measured using the Pittsburg Sleep Quality Index.
change from baseline to 8 weeks
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.
change from baseline to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dokuz Eylul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 7, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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