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

NCT ID: NCT06754124

Last Updated: 2025-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-15

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Epilepsy Cognitive Dysfunction Seizures Quality of Life Sleep Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Pilates Group

Pilates training will be given individually for approximately 1 hour, 3 days a week for 8 weeks.

Group Type EXPERIMENTAL

Pilates Group

Intervention Type OTHER

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.

Control Group

Routine medication will be continued for 8 weeks.

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Evaluation of core stability

"Core" stability was evaluated with two important dimensions, "core" strength and endurance tests.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Evaluation of Functional Exercise Capacity

Functional exercise capacity was evaluated using the 6 Minute Walking Test (6-MWT).

Group Type NO_INTERVENTION

No interventions assigned to this group

Evaluation of cognitive function

Cognitive function will be assessed with the Standardized Mini Mental State Examination and the Neuropsychological Test Battery for Cognitive Potentials.

Group Type NO_INTERVENTION

No interventions assigned to this group

Evaluation of dual task

Dual task will be evaluated by adding a second task to the Timed Up and Go Test (TUG).

Group Type NO_INTERVENTION

No interventions assigned to this group

Evaluation of fatigue

Fatigue will be assessed using the Fatigue Severity Scale (FSS).

Group Type NO_INTERVENTION

No interventions assigned to this group

Evaluation of kinesiophobia

Kinesiophobia will be assessed with the Tampa Kinesiophobia Scale (TKS).

Group Type NO_INTERVENTION

No interventions assigned to this group

Evaluation of sleep quality

Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI).

Group Type NO_INTERVENTION

No interventions assigned to this group

Evaluation of depression

The Inventory of Neurological Disorders Depression in Epilepsy will be used to assess depression.

Group Type NO_INTERVENTION

No interventions assigned to this group

Evaluation of quality of life

Quality of Life In Epilepsy (QOLIE-31) will be used to determine health-related quality of life in epilepsy.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Control Group

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Recep Tayyip Erdogan University Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Derya Çağlar

Research Asistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Derya CAGLAR, PhD candidate

Role: STUDY_DIRECTOR

Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation

Locations

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Recep Tayyip Erdogan University Vocational School of Physical Therapy and Rehabilitation

Rize, Güneysu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2024/10

Identifier Type: -

Identifier Source: org_study_id

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