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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06922747
Acronym
FIBROSTEPS
Enrollment
200
Registered
2025-04-10
Start date
2027-01-31
Completion date
2028-01-31
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia, Fibromyalgia (FM), Fibromyalgia Syndrome

Keywords

fibromyalgia impact questionnaire, randomized controlled trial, clinical trial, factorial design, 2*2 factorial design, physical activity, somatic tracking, activity, fibromyalgia, pain, effect study, musculoskeletal pain, rheumatic diseases, musculoskeletal diseases

Brief 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).

Interventions

OTHERGroup exercising

Weekly, supervised exercise sessions in groups

OTHERSomatic tracking

A psychological intervention aiming to learn the brain to reinterpret pain signals.

OTHERGeneral activity recommendaitons

General recommendaitons for physical activity and healthy lifestyle

Sponsors

University Hospital of North Norway
CollaboratorOTHER
University of Tromso
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The trial applies a 2\*2 factorial design.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total FIQ scoreAt 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

MeasureTime frameDescription
Resting heart rate24 weeksMeasured 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 intensity24 weeksSelf-reported pain intensity measured by Visual Analogue Scale (VAS). Participants will be asked to register their pain intensity once daily through a mobile application.
Steps per day24 weeksMeasured by Fitbit activity trackers
Minutes moderately active24 weeksMeasured by Fitbit
Minutes very active24 weeksMeasured by Fitbit
Sleep efficiency24 weeksMeasured by Fitbit. The formula for sleep efficiency is time asleep/(total time in bed - time to fall asleep)
Minutes lightly active24 weeksMeasured by Fitbit

Countries

Norway

Contacts

Primary ContactJohan Gustav Bellika
Johan.Gustav.Bellika@ehealthresearch.no+4795748049

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026