FIBROmyalgia: Somatic Tracking and Exercise Program Study

NCT06922747 — Not applicable, Not yet recruiting, 200 participants, University of Tromso

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

Registry	NCT06922747, acronym FIBROSTEPS
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, factorial, masking: none, treatment
Enrollment	200 (Estimated)
Sponsor	University of Tromso (Other); collaborators: University Hospital of North Norway
Conditions	Fibromyalgia (FM), Fibromyalgia, Fibromyalgia Syndrome
Interventions	Group exercising, Somatic tracking, General activity recommendaitons (Other)
Dates	start 2027-01-01 (estimated), primary completion 2028-01-01 (estimated), completion 2028-01-01 (estimated), first posted 2025-04-10, last updated 2025-05-13
Locations	1 site in Norway

-Summary

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.

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+Detailed description

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).

+Arms and interventions

Arm	Type	Interventions	Description
Group exercising	Experimental	Other: Group exercising	Receives weekly supervised group exercise sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.
Somatic tracking	Experimental	Other: Somatic tracking	Receives weekly sessions of somatic tracking by a certified therapist, a wrist-worn activity tracker, and access to national recommendations on physical activity.
Group exercising and somatic tracking	Experimental	Other: Group exercising; 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.
Control group	Active comparator	Other: General activity recommendaitons	Receives a wrist-worn activity tracker and access to national recommendations on physical activity.

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

+Outcome measures

Primary outcomes

Total FIQ score [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.

Secondary outcomes

Steps per day [24 weeks]: Measured by Fitbit activity trackers
Resting heart rate [24 weeks]: Measured by Fitbit
Insomnia Severity Index (ISI) [At end of baseline (8 weeks) and post-intervention (24 weeks)]: ISI is calculated from a questionnaire containing sleep and insomnia related questions
Self-reported pain intensity [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.
Minutes lightly active [24 weeks]: Measured by Fitbit
Minutes moderately active [24 weeks]: Measured by Fitbit
Minutes very active [24 weeks]: Measured by Fitbit
Sleep efficiency [24 weeks]: Measured by Fitbit. The formula for sleep efficiency is time asleep/(total time in bed - time to fall asleep)

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
University of Tromsø	Tromsø, Troms	Norway

+Funding

NIH grants: 2025