EpilepsyNCT06754124
Investigation of the Effects of Pilates Training in Patients With Drug-Resistant Epilepsy
A study testing Pilates Group in people with Epilepsy and Cognitive Dysfunction, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epilepsy, Cognitive Dysfunction, Seizures
- What is being tested?
- Pilates Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
Rize, Güneysu, 53350
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy, Cognitive Dysfunction, Seizures, Quality of Life, Sleep, Depression
- Being tested
- Pilates Group, Control Group
- Keywords
- Epilepsy, Cognitive Dysfunction, Seizures, Quality of Life, Sleep, Depression
- Medical subject headings
- Epilepsy, Cognitive Dysfunction, Seizures, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates GroupOther
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.
Control GroupOther
No exercise will be allowed for 8 weeks and routine medication will continue.
| Study group | Role | What they receive |
|---|---|---|
| Pilates Group | Experimental | Pilates training will be given individually for approximately 1 hour, 3 days a week for 8 weeks. Receives: Other: Pilates Group |
| Control Group | Active comparator | Routine medication will be continued for 8 weeks. Receives: Other: Control Group |
| Evaluation of seizure frequency | No intervention | 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. |
| Evaluation of core stability | No intervention | "Core" stability was evaluated with two important dimensions, "core" strength and endurance tests. |
| Evaluation of balance | No intervention | 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. |
| Evaluation of Functional Exercise Capacity | No intervention | Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT). |
| Evaluation of cognitive function | No intervention | Cognitive function will be assessed with the Standardized Mini Mental State Examination and the Neuropsychological Test Battery for Cognitive Potentials. |
| Evaluation of dual task | No intervention | Dual task will be evaluated by adding a second task to the Timed Up and Go Test (TUG). |
| Evaluation of fatigue | No intervention | Fatigue will be assessed using the Fatigue Severity Scale (FSS). |
| Evaluation of kinesiophobia | No intervention | Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale (TKS). |
| Evaluation of sleep quality | No intervention | Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). |
| Evaluation of depression | No intervention | The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression. |
| Evaluation of quality of life | No intervention | Quality of Life In Epilepsy (QOLIE-31) will be used to determine health-related quality of life in epilepsy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Physical Activity Level
Physical activity level will be assessed with the long form of the International Physical Activity Questionnaire (IPAQ).
Measured: 8 week
Evaluation of Seizure Frequency
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.
Measured: 8 week
Evaluation of the Strength of "Core" Muscles
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.
Measured: 8 week
Evaluation of the Endurance of "Core" Muscles
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.
Measured: 8 week
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.
Measured: 8 week
Evaluation of Functional Exercise Capacity
Functional exercise capacity will be assessed with the 6-Minute Walk Test (6-MWT) in accordance with the American Thoracic Society criteria.
Measured: 8 week
Evaluation of Cognitive Function
Cognitive function will be assessed with the Standardized Mini Mental Test and the Neuropsychological Test Battery for Cognitive Potentials.
Measured: 8 week
Evaluation of Dual Task
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.
Measured: 8 week
Evaluation of Fatigue
Fatigue will be assessed using the Fatigue Severity Scale.
Measured: 8 week
Evaluation of Kinesiophobia
Kinesiophobia will be assessed using the Tampa Kinesiophobia Scale.
Measured: 8 week
Evaluation of Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
Measured: 8 week
Evaluation of Depression
The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.
Measured: 8 week
Evaluation of Quality of Life
The Epilepsy Quality of Life Scale will be used to determine health-related quality of life in epilepsy.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start15 Nov 2024
- Primary completion20 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Derya Çağlar, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Derya CAGLAR, PhD candidate, Study director, Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754124
- Sponsor's protocol ID
- 2024/10
- Status last verified
- Jul 2025
- First submitted
- 4 Dec 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Assistant
- ClinicalTrials.gov ID
- NCT06754124
- Acronym / sponsor ID
- 2024/10
- Conditions
- Epilepsy, Cognitive Dysfunction, Seizures, Quality of Life, Sleep, Depression
- Keywords
- Epilepsy, Cognitive Dysfunction, Seizures, Quality of Life, Sleep, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| Pilates Group | Experimental | Other: Pilates GroupPilates training will be given individually for approximately 1 hour, 3 days a week for 8 weeks. |
| Control Group | Active comparator | Other: Control GroupRoutine medication will be continued for 8 weeks. |
| Evaluation of seizure frequency | No intervention | –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. |
| Evaluation of core stability | No intervention | –"Core" stability was evaluated with two important dimensions, "core" strength and endurance tests. |
| Evaluation of balance | No intervention | –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. |
| Evaluation of Functional Exercise Capacity | No intervention | –Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT). |
| Evaluation of cognitive function | No intervention | –Cognitive function will be assessed with the Standardized Mini Mental State Examination and the Neuropsychological Test Battery for Cognitive Potentials. |
| Evaluation of dual task | No intervention | –Dual task will be evaluated by adding a second task to the Timed Up and Go Test (TUG). |
| Evaluation of fatigue | No intervention | –Fatigue will be assessed using the Fatigue Severity Scale (FSS). |
| Evaluation of kinesiophobia | No intervention | –Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale (TKS). |
| Evaluation of sleep quality | No intervention | –Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI). |
| Evaluation of depression | No intervention | –The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression. |
| Evaluation of quality of life | No intervention | –Quality of Life In Epilepsy (QOLIE-31) will be used to determine health-related quality of life in epilepsy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilates GroupPilates 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. | Other | Pilates Group |
| Control GroupNo exercise will be allowed for 8 weeks and routine medication will continue. | Other | Control Group |
Primary outcome
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).
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.
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.
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.
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.
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.
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.
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.
Evaluation of Fatigue
Time frame: 8 week
Fatigue will be assessed using the Fatigue Severity Scale.
Evaluation of Kinesiophobia
Time frame: 8 week
Kinesiophobia will be assessed using the Tampa Kinesiophobia Scale.
Evaluation of Sleep Quality
Time frame: 8 week
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
Evaluation of Depression
Time frame: 8 week
The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya CAGLAR, PhD candidate study director
Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates Group in people with Epilepsy and Cognitive Dysfunction, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Physical Activity Level (time frame: 8 week). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.