An interventional study of Group exercising and Somatic tracking in Fibromyalgia (FM), Fibromyalgia and Fibromyalgia Syndrome, sponsored by University of Tromso. Not yet recruiting at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by University of Tromso · Not applicable, Interventional, and Treatment
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:
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:
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).
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →University of Tromso is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receives weekly supervised group exercise sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.
Other: Group exercising
Receives weekly sessions of somatic tracking by a certified therapist, a wrist-worn activity tracker, and access to national recommendations on physical activity.
Other: Somatic tracking
Receives weekly group exercise sessions, weekly somatic tracking sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.
Other: Group exercising · Other: Somatic tracking
Receives a wrist-worn activity tracker and access to national recommendations on physical activity.
Other: General activity recommendaitons
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
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
Plan to share: No
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This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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University of Tromso