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Набор скоро начнётся NCT06922747

FIBROmyalgia: Somatic Tracking and Exercise Program Study

Без фазы С лечением Fibromyalgia (FM) Fibromyalgia Fibromyalgia Syndrome

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: Group exercising, Somatic tracking, General activity recommendaitons.
Кому может быть актуально
Состояния в реестре: Fibromyalgia (FM), Fibromyalgia, Fibromyalgia Syndrome. Базовые параметры: 18 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Норвегия
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

FIBROSTEPS Protocol: A 2×2 Factorial Randomized Controlled Trial Evaluating Group Exercise and Somatic Tracking in Fibromyalgia

Обзор

The goal of this clinical trial is to learn if the combination of two interventions is more effective in treating fibromyalgia symptoms than one intervention alone. The participant group will be people with fibromyalgia in age group 18-65 years. The two interventions to be tested over sixteen weeks are: * weekly exercise sessions in groups * weekly consultations with a therapist The main question it aims to answer is: Is the combination of group exercising and somatic tracking work more efficient than physical activity alone in terms of managing fibromyalgia? Participants will wear Fitbit activity trackers, register pain intensity daily on a mobile app, and answer the Fibromyalgia Impact Questionnaire (FIQ). They will be divided into four groups: * one group receiving the exercise intervention * one group receiving the psychological intervention * one group receiving both intervention * one control group recieving general physical activity recommendations Before the sixteen weeks intervention period, there will be a baseline period of eight weeks. Durng the baseline period, participants will wear activity trackers and maintain their usual lifestyle. Researchers will compare the combination of the interventions against only one intervention and the control group.

Подробное описание

Fibromyalgia is a chronic condition characterised by musculoskeletal pain, fatigue, poor sleep and an overall reduced quality of life. It is well known that physical activity improves symtpons of fibromyalgia, although not all people affected by the condition have positive experiences from exercising. People with fibromyalgia have also stated that physical activity alone is not enough for managing symptomes effectively. This is the background for the proposed randomized controlled trial with a 2\*2 factorial design, where two interventions are tested, alone and in combination.

There will be a baseline period of 8 weeks and an intervention period of 16 weeks.

Evaluations will occur at the end of the baseline period (8 weeks) and at the end of the intervention period (24 weeks).

Вмешательства

  • Другое Group exercising
    Weekly, supervised exercise sessions in groups
  • Другое Somatic tracking
    A psychological intervention aiming to learn the brain to reinterpret pain signals.
  • Другое General activity recommendaitons
    General recommendaitons for physical activity and healthy lifestyle

Первичные конечные точки

  • Total FIQ score [Срок оценки: At end of baseline (8 weeks) and post-intervention (24 weeks)]
Вторичные конечные точки (8)
  • Steps per day [Срок оценки: 24 weeks]
  • Resting heart rate [Срок оценки: 24 weeks]
  • Insomnia Severity Index (ISI) [Срок оценки: At end of baseline (8 weeks) and post-intervention (24 weeks)]
  • Self-reported pain intensity [Срок оценки: 24 weeks]
  • Minutes lightly active [Срок оценки: 24 weeks]
  • Minutes moderately active [Срок оценки: 24 weeks]
  • Minutes very active [Срок оценки: 24 weeks]
  • Sleep efficiency [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

  • Diagnosed with fibromyalgia according to the criteria specified in Wolfe et al (2016)
  • Able to perform light physical activity
  • Able to provide written informed consent
  • Owning a smartphone
  • Able to be followed for 24 weeks

Критерии исключения

  • Pregnant
  • Severe co-morbid psychiatric or neurological disorders
  • Current participation in another clinical trial
  • Recent surgery or other physical constraints preventing exercise

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Норвегия · 1 центр
  • University of Tromsø — Tromsø

Идентификаторы

NCT: NCT06922747 · 2025/853403(REK) · University of Tromso

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗