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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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
University of Tromsø
Tromsø, Troms, Norway
Total FIQ score
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: At end of baseline (8 weeks) and post-intervention (24 weeks)
Steps per day
Measured by Fitbit activity trackers
Time frame: 24 weeks
Resting heart rate
Measured by Fitbit
Time frame: 24 weeks
Insomnia Severity Index (ISI)
ISI is calculated from a questionnaire containing sleep and insomnia related questions
Time frame: At end of baseline (8 weeks) and post-intervention (24 weeks)
Self-reported pain intensity
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
Minutes lightly active
Measured by Fitbit
Time frame: 24 weeks
Minutes moderately active
Measured by Fitbit
Time frame: 24 weeks
Minutes very active
Measured by Fitbit
Time frame: 24 weeks
Sleep efficiency
Measured by Fitbit. The formula for sleep efficiency is time asleep/(total time in bed - time to fall asleep)
Time frame: 24 weeks
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