Clinical trial NCT06754124: Investigation of the Effects of Pilates Training in Patients with Drug-Resistant Epilepsy
Official title: Research Assistant
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Cognitive Dysfunction
Seizures
Quality of Life
Sleep
Depression
Keywords: Epilepsy
Cognitive Dysfunction
Seizures
Quality of Life
Sleep
Depression
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of Physical Activity Level
timeFrame: 8 week
measure: Evaluation of Seizure Frequency
timeFrame: 8 week
measure: Evaluation of the Strength of "Core" Muscles
timeFrame: 8 week
measure: Evaluation of the Endurance of "Core" Muscles
timeFrame: 8 week
measure: Evaluation of Balance
timeFrame: 8 week
measure: Evaluation of Functional Exercise Capacity
timeFrame: 8 week
measure: Evaluation of Cognitive Function
timeFrame: 8 week
measure: Evaluation of Dual Task
timeFrame: 8 week
measure: Evaluation of Fatigue
timeFrame: 8 week
measure: Evaluation of Kinesiophobia
timeFrame: 8 week
measure: Evaluation of Sleep Quality
timeFrame: 8 week
measure: Evaluation of Depression
timeFrame: 8 week
measure: Evaluation of Quality of Life
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
state: Güneysu
Study officials:
affiliation: Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation
name: Derya CAGLAR, PhD candidate
role: STUDY_DIRECTOR
References: