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

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: Completed
• Conditions: Depression; Epilepsy; Quality of Life; Sleep; Cognitive Dysfunction; Seizures
• Intervention / Treatment: Other: Pilates Group; Other: Control Group

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

13

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Recep Tayyip Erdogan University Training and Research Hospital
• Investigators: Study Director: Derya CAGLAR, PhD candidate, Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Actual): June 20, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 4, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 20, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Epilepsy; Depression; Quality of Life; Sleep; Seizures; Cognitive Dysfunction
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Depression; Epilepsy; Seizures
• Other Study ID 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