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

Research Assistant

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06754124
Enrollment
30
Registered
2024-12-31
Start date
2024-11-15
Completion date
2025-06-30
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Cognitive Dysfunction, Seizures, Quality of Life, Sleep, Depression

Keywords

Epilepsy, Cognitive Dysfunction, Seizures, Quality of Life, Sleep, Depression

Brief 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. 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.

Interventions

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.

OTHERControl Group

No exercise will be allowed for 8 weeks and routine medication will continue.

Sponsors

Recep Tayyip Erdogan University Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of Physical Activity Level8 weekPhysical activity level will be assessed with the long form of the International Physical Activity Questionnaire (IPAQ).
Evaluation of Seizure Frequency8 weekSeizure 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 Muscles8 weekCore 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 Muscles8 weekStatic 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 Balance8 weekBalance 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 Capacity8 weekFunctional exercise capacity will be assessed with the 6-Minute Walk Test (6-MWT) in accordance with the American Thoracic Society criteria.
Evaluation of Cognitive Function8 weekCognitive function will be assessed with the Standardized Mini Mental Test and the Neuropsychological Test Battery for Cognitive Potentials.
Evaluation of Dual Task8 weekDual 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 Fatigue8 weekFatigue will be assessed using the Fatigue Severity Scale.
Evaluation of Kinesiophobia8 weekKinesiophobia will be assessed using the Tampa Kinesiophobia Scale.
Evaluation of Sleep Quality8 weekSleep quality will be assessed using the Pittsburgh Sleep Quality Index.
Evaluation of Depression8 weekThe Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.
Evaluation of Quality of Life8 weekThe Epilepsy Quality of Life Scale will be used to determine health-related quality of life in epilepsy.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026