Research Assistant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Evaluation of Physical Activity Level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Evaluation of Functional Exercise Capacity
Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT).
Pilates Group
Pilates training will be given individually for approximately 1 hour, 3 days a week for 8 weeks.
干预措施: Pilates Group (Other)
Control Group
Routine medication will be continued for 8 weeks.
干预措施: Control Group (Other)
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.
Evaluation of core stability
"Core" stability was evaluated with two important dimensions, "core" strength and endurance tests.
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.
Evaluation of cognitive function
Cognitive function will be assessed with the Standardized Mini Mental State Examination and the Neuropsychological Test Battery for Cognitive Potentials.
Evaluation of dual task
Dual task will be evaluated by adding a second task to the Timed Up and Go Test (TUG).
Evaluation of fatigue
Fatigue will be assessed using the Fatigue Severity Scale (FSS).
Evaluation of kinesiophobia
Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale (TKS).
Evaluation of sleep quality
Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).
Evaluation of depression
The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.
Evaluation of quality of life
Quality of Life In Epilepsy (QOLIE-31) will be used to determine health-related quality of life in epilepsy.
结局指标
主要结局
Evaluation of Physical Activity Level
时间窗: 8 week
Physical activity level will be assessed with the long form of the International Physical Activity Questionnaire (IPAQ).
Evaluation of Seizure Frequency
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 8 week
Fatigue will be assessed using the Fatigue Severity Scale.
Evaluation of Kinesiophobia
时间窗: 8 week
Kinesiophobia will be assessed using the Tampa Kinesiophobia Scale.
Evaluation of Sleep Quality
时间窗: 8 week
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
Evaluation of Depression
时间窗: 8 week
The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.
Evaluation of Quality of Life
时间窗: 8 week
The Epilepsy Quality of Life Scale will be used to determine health-related quality of life in epilepsy.
次要结局
未报告次要终点
研究者
Derya Çağlar
Research Asistant
Recep Tayyip Erdogan University Training and Research Hospital