FIBROmyalgia: Somatic Tracking and Exercise Program Study (FIBROSTEPS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia; Fibromyalgia Syndrome; Fibromyalgia (FM)
• Intervention / Treatment: Other: Group exercising; Other: Somatic tracking; Other: General activity recommendaitons

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).

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Johan Gustav Bellika; Phone Number: +4795748049; Email: Johan.Gustav.Bellika@ehealthresearch.no

Study Locations

• Norway
  • Troms
    • Tromsø, Troms, Norway, 9019
      • University of Tromsø

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group exercising; Receives weekly supervised group exercise sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.	Other: Group exercising; Weekly, supervised exercise sessions in groups
Experimental: 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.	Other: Somatic tracking; A psychological intervention aiming to learn the brain to reinterpret pain signals.
Experimental: Group exercising and 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; Weekly, supervised exercise sessions in groups; Other: Somatic tracking; A psychological intervention aiming to learn the brain to reinterpret pain signals.
Active Comparator: Control group; Receives a wrist-worn activity tracker and access to national recommendations on physical activity.	Other: General activity recommendaitons; General recommendaitons for physical activity and healthy lifestyle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At end of baseline (8 weeks) and post-intervention (24 weeks)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Tromso
• Collaborators: University Hospital of North Norway

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 10, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; pain; randomized controlled trial; fibromyalgia; clinical trial; rheumatic diseases; activity; musculoskeletal pain; factorial design; musculoskeletal diseases; 2*2 factorial design; somatic tracking; fibromyalgia impact questionnaire; effect study
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: 2025/853403(REK); University of Tromso (Other Identifier: University of Tromso)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No