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Идёт набор NCT06424743

Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training

Без фазы С лечением Fibromyalgia, Primary Chronic Pain Exercise Addiction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: exercise.
Кому может быть актуально
Состояния в реестре: Fibromyalgia, Primary, Chronic Pain, Exercise Addiction. Базовые параметры: 18 лет — 65 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бразилия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Preference of Women With Fibromyalgia Undergoing a Three Different Volumes of Resistance Training: Clinical Trial Randomized Crossover

Обзор

Fibromyalgia is a painful syndrome of unknown etiology, which affects 2% of world population, with symptoms such as: pain, unrefreshing sleep, fatigue and mood disorders. It is already established in the literature that resistance training is part of the non- pharmacological treatment for patients with fibromyalgia. The big gap is about the quantity adequate and/or recommended exercise volume, despite some studies with exercise volumes different resistance trainings show improvements, we do not have a direction, besides We still do not know whether there is a preference for these patients in different resistance training volumes.

Подробное описание

Objective: Assess training volume preference resisted in women with fibromyalgia.

Method: Crossover randomized clinical trial, randomized and blind. 36 women with fibromyalgia will be evaluated, who will undergo three resistance training programs with different training volumes. The primary outcome will be patient preference in relation to training volumes, and the secondary ones will be the patient expectation, pain intensity, affect and subjective perception of exertion.

Analysis statistics: For the primary outcome preference, the number of choices will be counted of the 3 types of training in percentage form. Regarding the analysis of the primary outcome we will summarize the patient's preference in a contingency table, we will compare the proportions using the Chi-square test, and finally we will check the effect size of the observed differences. For secondary outcomes, statistical analyzes will be performed by a blind statistician using commercial software. The Kolmogorov-Smirnov test will be applied to verify the distribution of data and Levene's test will be used to analyze the homogeneity of variance. The Bonferroni test will be used in post hoc analyzes to determine whether there are differences between the groups at different intervention times. One 5% significance level and 95% CI will be adopted for all statistical analyses. ethic and dissemination: The results of the study will be disseminated to participants and subjected to a peer-reviewed journal and scientific meetings.

Вмешательства

  • Другое exercise
    exercise programs with different volumes

Первичные конечные точки

  • Choose one of the workouts according to your preference [Срок оценки: 28 day]
Вторичные конечные точки (4)
  • Change in Expectation [Срок оценки: baseline]
  • Change in Pain intensity [Срок оценки: baseline, 28 day]
  • Change in Affection [Срок оценки: baseline, 28 day]
  • Change in Subjective perception of exertion [Срок оценки: baseline, 28 day]

Критерии участия

Критерии включения

  • Women aged 18 to 65
  • Have a diagnosis of fibromyalgia according to the ACR 2016 criteria

Критерии исключения

  • Have performed resistance training in the last 6 months
  • Having another associated rheumatic condition
  • Have a trip or appointment scheduled that requires absence for the next 4 (four) weeks from the start of the survey;
  • Women with musculoskeletal injuries in the upper and/or lower limbs
  • Have heart problems that prevent maximal efforts and submaximums

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Бразилия · 1 центр
  • Marcelo Cardoso de Souza — Natal

Публикации

  • Silva HJA, Assuncao Junior JC, de Oliveira FS, Oliveira JMP, Figueiredo Dantas GA, Lins CAA, de Souza MC. Sophrology versus resistance training for treatment of women with fibromyalgia: A randomized controlled trial. J Bodyw Mov Ther. 2019 Apr;23(2):382-389. doi: 10.1016/j.jbmt.2018.02.005. Epub 2018 Feb 12. PMID 31103124
  • Cavalcanti BH, Pontes-Silva A, Souza CG, Avila MA, de Souza MC. Do Fibromyalgia Patients Have a Preferred Resistance Training Volume? Protocol for a Randomized Crossover Clinical Trial. Physiother Res Int. 2025 Oct;30(4):e70101. doi: 10.1002/pri.70101. PMID 40886126

Идентификаторы

NCT: NCT06424743 · UFRNpreference

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗