University of Tromsø
Tromsø, Troms, 9019, Norway
NCT Number: NCT06922747
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Tromsø, Troms, 9019, Norway
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weekly, supervised exercise sessions in groups
A psychological intervention aiming to learn the brain to reinterpret pain signals.
General recommendaitons for physical activity and healthy lifestyle
Time frame: At end of baseline (8 weeks) and post-intervention (24 weeks)
Fibromyalgia Impact Questionnaire (FIQ) is widely used in clinical trials in fibromyalgia patients. The questionnaire contains questions that are answered using a scale. The scores from each question are used to calculate a total FIQ score.
Time frame: 24 weeks
Measured by Fitbit activity trackers
Time frame: 24 weeks
Measured by Fitbit
Time frame: At end of baseline (8 weeks) and post-intervention (24 weeks)
ISI is calculated from a questionnaire containing sleep and insomnia related questions
Time frame: 24 weeks
Self-reported pain intensity measured by Visual Analogue Scale (VAS). Participants will be asked to register their pain intensity once daily through a mobile application.
Time frame: 24 weeks
Measured by Fitbit
Time frame: 24 weeks
Measured by Fitbit
Time frame: 24 weeks
Measured by Fitbit
Time frame: 24 weeks
Measured by Fitbit. The formula for sleep efficiency is time asleep/(total time in bed - time to fall asleep)
Contact information is provided by the study sponsor or research team.
University of Tromso
Other
FIBROSTEPS Protocol: A 2×2 Factorial Randomized Controlled Trial Evaluating Group Exercise and Somatic Tracking in Fibromyalgia
Acronym: FIBROSTEPS
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