Investigation of the Effects of Pilates Training in Patients With Drug-Resistant Epilepsy
Research Assistant
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2024
CompletedFirst Submitted
Initial submission to the registry
December 4, 2024
CompletedFirst Posted
Study publicly available on registry
December 31, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJuly 22, 2025
July 1, 2025
7 months
December 4, 2024
July 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
Evaluation of Physical Activity Level
Physical activity level will be assessed with the long form of the International Physical Activity Questionnaire (IPAQ).
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.
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.
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.
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.
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.
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.
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.
8 week
Evaluation of Fatigue
Fatigue will be assessed using the Fatigue Severity Scale.
8 week
Evaluation of Kinesiophobia
Kinesiophobia will be assessed using the Tampa Kinesiophobia Scale.
8 week
Evaluation of Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
8 week
Evaluation of Depression
The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.
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.
8 week
Study Arms (13)
Pilates Group
EXPERIMENTALPilates training will be given individually for approximately 1 hour, 3 days a week for 8 weeks.
Control Group
ACTIVE COMPARATORRoutine medication will be continued for 8 weeks.
Evaluation of seizure frequency
NO INTERVENTIONSeizure 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 INTERVENTIONBalance 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 INTERVENTIONFunctional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT).
Evaluation of cognitive function
NO INTERVENTIONCognitive function will be assessed with the Standardized Mini Mental State Examination and the Neuropsychological Test Battery for Cognitive Potentials.
Evaluation of dual task
NO INTERVENTIONDual task will be evaluated by adding a second task to the Timed Up and Go Test (TUG).
Evaluation of fatigue
NO INTERVENTIONFatigue will be assessed using the Fatigue Severity Scale (FSS).
Evaluation of kinesiophobia
NO INTERVENTIONKinesiophobia will be assessed with the Tampa Kinesiophobia Scale (TKS).
Evaluation of sleep quality
NO INTERVENTIONSleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).
Evaluation of depression
NO INTERVENTIONThe Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.
Evaluation of quality of life
NO INTERVENTIONQuality of Life In Epilepsy (QOLIE-31) will be used to determine health-related quality of life in epilepsy.
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.
No exercise will be allowed for 8 weeks and routine medication will continue.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
Rize, Güneysu, 53350, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Derya CAGLAR, PhD candidate
Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Asistant
Study Record Dates
First Submitted
December 4, 2024
First Posted
December 31, 2024
Study Start
November 15, 2024
Primary Completion
June 20, 2025
Study Completion
June 30, 2025
Last Updated
July 22, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share