NCT06922747

FIBROmyalgia: Somatic Tracking and Exercise Program Study

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Tromso · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Fibromyalgia (FM)
• Fibromyalgia
• Fibromyalgia Syndrome

Interventions

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

Timeline

• Start date: 2027-01-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-04-10
• Last updated: 2025-05-13

Locations

1 site across 1 country: Norway