Investigation of the Effects of Pilates Training in Patients With Drug-Resistant Epilepsy

July 20, 2025 updated by: Derya Çağlar, Recep Tayyip Erdogan University Training and Research Hospital

Research Assistant

This study was planned to examine the effects of Pilates training in patients with drug-resistant epilepsy. It was planned to include 40 epilepsy patients in the study. The control group was planned to continue routine drug treatment for 8 weeks. The Pilates group was planned to receive Pilates training 3 days a week for 8 weeks in addition to routine drug treatment. It was aimed to examine the effects of Pilates training performed 3 times a week for 8 weeks on seizure frequency, core stability, balance, functional exercise capacity, cognitive functions, dual task, fatigue, kinesiophobia, sleep quality, depression and quality of life in patients with drug-resistant epilepsy.

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.

Detailed Description

This study was planned to investigate the effects of Pilates training, a "core" stability-based exercise method that improves body alignment, postural control, and balance in patients with drug-resistant epilepsy, on seizure frequency, core stability, balance, functional exercise capacity, cognitive functions, dual task, fatigue, kinesiophobia, sleep quality, depression, and quality of life. It was planned to include 40 epilepsy patients in the study. The patients were planned to be randomly divided into two groups as Pilates (n: 20) and control (n: 20). The control group was planned to continue routine drug treatment for 8 weeks. The Pilates group was planned to receive Pilates training 3 days a week for 8 weeks in addition to routine drug treatment. Seizure frequency with the seizure diary; the "core" power with the "sit-ups" and the modified "push-ups" tests; the "core" endurans with the lateral bridge, the trunk flexor endurance, the prone bridge and the modified "Biering-Sorensen" tests; balance with the Balance Error Scoring System (BESS) and the Four-Step Square Test (FSTT); functional exercise capacity with the 6-Minute Walk Test (6-MWT); functional mobility and dual task with the Timed Up and Go Test (TUG); cognitive functions with the BILNOT battery; fatigue with the Fatigue Severity Scale (FSS); kinesiophobia with the Tampa Kinesiophobia Scale; sleep quality with the Pittsburgh Sleep Quality Index (PSQI); depression with the Neurological Disorders Depression Inventory in Epilepsy (NDDI); and health-related quality of life with the Quality of Life in Epilepsy Scale (QOLIE-31) were evaluated before and after treatment.

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.
30

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
    • Güneysu
      • Rize, Güneysu, Turkey, 53350
        • Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being between the ages of 18-65
  • Being diagnosed with idiopathic refractory epilepsy by a specialist neurologist
  • Not having had status epilepticus for 1 year before the study
  • Being able to walk independently
  • Not having participated in a regular exercise program
  • Having a Standardized Mini Mental Test score greater than 24
  • Antiepileptic drug doses being stable during the study

Exclusion Criteria:

  • History of any diagnosed neurological or neuropsychiatric disease other than epilepsy
  • Presence of any cardiovascular, pulmonary, orthopedic or other medical conditions that would limit participation in the study
  • Pregnancy and breastfeeding

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: Crossover Assignment
  • Masking: Double

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.
No Intervention: Evaluation of Functional Exercise Capacity
Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT).
Experimental: Pilates Group
Pilates training will be given individually for approximately 1 hour, 3 days a week for 8 weeks.
Other: Pilates Group
Pilates training will be given individually for approximately 1 hour, 3 days a week for 8 weeks. Before starting the exercise training, all participants will be taught the basic elements of Pilates in 1 session. Pilates training will begin with standing exercises for warming up and centering in the supine position. Training will continue with upper and lower extremity movements. The intensity of the exercises will be increased by using different positions and elastic bands. Stretching exercises and posture exercises will be used during the cool-down period. All exercises will start with 10 repetitions and will be increased to 20 later. Each movement will be shown by the physiotherapist first so that the patients can do the movements correctly. The movements that the patients cannot do will be modified appropriately and applied.
Active Comparator: Control Group
Routine medication will be continued for 8 weeks.
Other: Control Group
No exercise will be allowed for 8 weeks and routine medication will continue.
No Intervention: Evaluation of seizure frequency
Seizure frequency will be calculated based on the patient's diary in the 2 months prior to the assessment. Patients without a seizure diary will be given one and asked to record their seizures for 2 months.
No Intervention: Evaluation of core stability
"Core" stability was evaluated with two important dimensions, "core" strength and endurance tests.
No Intervention: Evaluation of balance
Balance will be assessed separately with static and dynamic balance tests. The Balance Error Scoring System test will be used to assess static balance, and the Four-Step Square Test will be used to assess dynamic balance.
No Intervention: Evaluation of cognitive function
Cognitive function will be assessed with the Standardized Mini Mental State Examination and the Neuropsychological Test Battery for Cognitive Potentials.
No Intervention: Evaluation of dual task
Dual task will be evaluated by adding a second task to the Timed Up and Go Test (TUG).
No Intervention: Evaluation of fatigue
Fatigue will be assessed using the Fatigue Severity Scale (FSS).
No Intervention: Evaluation of kinesiophobia
Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale (TKS).
No Intervention: Evaluation of sleep quality
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).
No Intervention: Evaluation of depression
The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.
No Intervention: Evaluation of quality of life
Quality of Life In Epilepsy (QOLIE-31) will be used to determine health-related quality of life in epilepsy.

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
Evaluation of Physical Activity Level
Time Frame: 8 week
Physical activity level will be assessed with the long form of the International Physical Activity Questionnaire (IPAQ).
8 week
Evaluation of Seizure Frequency
Time Frame: 8 week
Seizure frequency will be calculated based on the patient's seizure diary for the 2 months prior to the assessment. Patients without a seizure diary will be given a seizure diary and asked to record their seizures for 2 months.
8 week
Evaluation of the Strength of "Core" Muscles
Time Frame: 8 week
Core muscle strength will be assessed with sit-ups and modified push-ups. The number of times individuals can perform each test for 30 seconds will be recorded. Each measurement will be made twice and the best measurement will be used in statistical analysis.
8 week
Evaluation of the Endurance of "Core" Muscles
Time Frame: 8 week
Static endurance of the core muscles will be assessed using the McGill protocol using the lateral bridge test, the Modified Biering-Sorensen trunk extension test, the trunk flexor endurance test, and the prone bridge test. The time that individuals can maintain the test position will be recorded in seconds using a stopwatch. Each measurement will be made twice and the best measurement will be used in the statistical analysis. The test will be terminated when individuals break the test position or say that they cannot continue the test.
8 week
Evaluation of Balance
Time Frame: 8 week
Balance will be assessed separately with static and dynamic balance tests. The Balance Error Scoring System test will be used to assess static balance, and the Four-Step Square Test will be used to assess dynamic balance.
8 week
Evaluation of Functional Exercise Capacity
Time Frame: 8 week
Functional exercise capacity will be assessed with the 6-Minute Walk Test (6-MWT) in accordance with the American Thoracic Society criteria.
8 week
Evaluation of Cognitive Function
Time Frame: 8 week
Cognitive function will be assessed with the Standardized Mini Mental Test and the Neuropsychological Test Battery for Cognitive Potentials.
8 week
Evaluation of Dual Task
Time Frame: 8 week
Dual task will be evaluated by adding a second task to the Timed Up and Go Test. For the motor task, individuals will be asked to carry an empty tray. For the cognitive task, they will be asked to count backwards from 100 by 7s (mental tracking) and to count words starting with the letter A (verbal fluency). The time will be recorded with a stopwatch. The test will be done twice, one as a trial, and the final measurement will be used in statistical analysis.
8 week
Evaluation of Fatigue
Time Frame: 8 week
Fatigue will be assessed using the Fatigue Severity Scale.
8 week
Evaluation of Kinesiophobia
Time Frame: 8 week
Kinesiophobia will be assessed using the Tampa Kinesiophobia Scale.
8 week
Evaluation of Sleep Quality
Time Frame: 8 week
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
8 week
Evaluation of Depression
Time Frame: 8 week
The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.
8 week
Evaluation of Quality of Life
Time Frame: 8 week
The Epilepsy Quality of Life Scale will be used to determine health-related quality of life in epilepsy.
8 week

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.
Recep Tayyip Erdogan University Training and Research Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Derya CAGLAR, PhD candidate, Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation

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.
November 15, 2024

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.
June 20, 2025

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.
June 30, 2025

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).
December 4, 2024

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.
December 20, 2024

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.
December 31, 2024

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.
July 22, 2025

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.
July 20, 2025

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.
July 1, 2025

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.
  • 2024/10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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