- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07591766
Aerobic Dance Exercises in Fibromyalgia Syndrome
15 мая 2026 г. обновлено: Tugba Civi Karaaslan, Istanbul University
The Effectiveness of Aerobic Dance Exercises in Fibromyalgia Syndrome: A Randomized Controlled Trial
The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises.
Обзор исследования
Статус
Завершенный
Вмешательство/лечение
Подробное описание
The aim of this study was to evaluate the effects of aerobic dance exercises on patients with Fibromyalgia syndrome (FMS) and to compare these effects with those of conventional postural exercises.
A total of 44 female participants were included.
Group-1 (n=22) received aerobic dance exercises twice a week for eight weeks, while Group-2 (n=22) was given a conventional postural exercise program as a home-based intervention with the same duration and frequency.
To evaluate the participants, the following assessment tools were used: Fibromyalgia Impact Questionnaire, McGill-Melzack Pain Questionnaire, Short Form-36, Pittsburgh Sleep Quality Index, Beck Depression Inventory, International Physical Activity Questionnaire-Short Form, and Fatigue Severity Scale.
Both groups showed significant improvements in nearly all parameters after the intervention (p<0.05).
Тип исследования
Интервенционный
Регистрация (Действительный)
44
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Istanbul, Турция (Туркие)
- Istanbul University-Cerrahpaşa
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
Inclusion Criteria:
- diagnosis of FMS according to the American College of Rheumatology (ACR) diagnostic criteria
- being female between the ages of 18 and 65
- having the physical capacity to exercise
Exclusion Criteria:
- unstable angina pectoris with severe dyspnea that would prevent exercise
- the presence of any neurological or orthopedic disease other than FMS
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Aerobic Dance Exercises
The aerobic protocol for Group-1 was divided into four distinct phases: warm-up, endurance training, stretching, and cooling down.
These sessions were led by a physiotherapist in groups of five, using music to guide the exercise rhythm.
Initial warm-ups lasted 5 to 7 minutes and involved stationary marching and stepping patterns.
A 20-minute core segment followed, featuring group dance movements that incorporated various torso and limb rotations.
Cardiovascular challenge was integrated through 5 minutes of rapid-paced dance.
The program ended with a 5-minute cool-down period where participants gradually reduced their activity level in alignment with a slowing musical tempo.
|
The aerobic protocol for Group-1 was divided into four distinct phases: warm-up, endurance training, stretching, and cooling down.
These sessions were led by a physiotherapist in groups of five, using music to guide the exercise rhythm.
Initial warm-ups lasted 5 to 7 minutes and involved stationary marching and stepping patterns.
A 20-minute core segment followed, featuring group dance movements that incorporated various torso and limb rotations.
Cardiovascular challenge was integrated through 5 minutes of rapid-paced dance.
The program ended with a 5-minute cool-down period where participants gradually reduced their activity level in alignment with a slowing musical tempo.
|
|
Экспериментальный: Conventional Exercises
To improve muscle balance and protect spinal integrity, Group-2 performed conventional posture exercises targeting the neck, back, core, and shoulders.
This routine, a common clinical approach for individuals with FMS, was conducted as a home-based program with a frequency of two sessions per week.
To ensure compliance and track progress, each participant utilized a dedicated exercise diary to record their activities throughout the study.
|
To improve muscle balance and protect spinal integrity, Group-2 performed conventional posture exercises targeting the neck, back, core, and shoulders.
This routine, a common clinical approach for individuals with FMS, was conducted as a home-based program with a frequency of two sessions per week.
To ensure compliance and track progress, each participant utilized a dedicated exercise diary to record their activities throughout the study.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Fibromyalgia Impact Scale
Временное ограничение: change from baseline at 8 weeks
|
To measure the impact of the disease on daily life, a 20-question assessment tool was utilized, focusing on domains such as physical capacity, occupational health, and psychological well-being.
Additionally, the scale screens for pain intensity, stiffness, sleep quality, and overall vitality.
The scoring system is structured such that higher results indicate more pronounced symptoms and lower functional capacity, while lower scores reflect better health status.
Total scores range from 0 to 100, with higher scores indicating greater disease impact and poorer functional status.
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change from baseline at 8 weeks
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McGill-Melzack Pain Scale
Временное ограничение: change from baseline at 8 weeks
|
To characterize the nature and intensity of the pain, the McGill-Melzack scale was utilized.
This assessment encompasses a detailed analysis of pain topography, its sensory qualities, and duration.
It also accounts for specific triggers or modifiers of pain frequency.
Scoring is interpreted such that higher cumulative values reflect more profound pain symptoms and increased clinical severity.Total scores range from 0 to 78, with higher scores indicating greater pain severity and pain-related distress
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change from baseline at 8 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Short Form-36 Health Survey (SF-36)
Временное ограничение: change from baseline at 8 weeks
|
The Short Form-36 Health Survey is a comprehensive 36-item questionnaire used to assess health-related quality of life, including physical functioning, psychosocial functioning, pain, and mental health status.
Each subscale is scored on a scale ranging from 0 to 100, with higher scores indicating better functional status and improved overall health-related quality of life.
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change from baseline at 8 weeks
|
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Pittsburgh Sleep Quality Index
Временное ограничение: change from baseline at 8 weeks
|
The PSQI was utilized to measure participants' self-reported sleep quality and related disturbances.
The scale comprises 19 items that form seven sub-scores, which are then aggregated into a single global score between 0 and 21.
While lower scores are indicative of better sleep quality, a cumulative score higher than five is clinically interpreted as a sign of significant sleep dysfunction.
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change from baseline at 8 weeks
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Beck Depression Inventory
Временное ограничение: change from baseline at 8 weeks
|
To evaluate participants' depressive states, the BDI, which consists of 21 questions, was utilized.
Each item is scored between 0 and 3, and the total score is used to determine the intensity of the symptoms.
Clinical classifications were made based on the total score: 0-9 points as no depression, 10-16 points as mild, 17-23 points as moderate, and any value 24 or above as severe depression.
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change from baseline at 8 weeks
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International Physical Activity Questionnaire-Short Form
Временное ограничение: change from baseline at 8 weeks
|
The International Physical Activity Questionnaire-Short Form will be used to assess participants' physical activity levels.
The questionnaire evaluates the frequency and duration of walking, moderate-intensity activity, vigorous-intensity activity, and sedentary behavior over the last 7 days.
Total physical activity is calculated in metabolic equivalent (MET)-minutes/week.
Higher scores indicate higher levels of physical activity.
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change from baseline at 8 weeks
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Fatigue Severity Scale
Временное ограничение: change from baseline at 8 weeks
|
To evaluate the impact of fatigue, the FSS, which views fatigue severity as a single-dimensional construct, was administered.
Participants responded to nine statements using a scoring range from 1 to 7. The overall fatigue score was derived from the average of these ratings; consequently, an increase in the total score indicates a greater level of perceived fatigue.
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change from baseline at 8 weeks
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
6 мая 2022 г.
Первичное завершение (Действительный)
6 января 2023 г.
Завершение исследования (Действительный)
6 мая 2023 г.
Даты регистрации исследования
Первый отправленный
5 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
15 мая 2026 г.
Первый опубликованный (Действительный)
18 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
15 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IstanbulUC4
Планирование данных отдельных участников (IPD)
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НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .