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NCT Number: NCT06922747

FIBROmyalgia: Somatic Tracking and Exercise Program Study

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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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Total FIQ score

    Time frame: 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

  1. Steps per day

    Time frame: 24 weeks

    Measured by Fitbit activity trackers

  2. Resting heart rate

    Time frame: 24 weeks

    Measured by Fitbit

  3. Insomnia Severity Index (ISI)

    Time frame: At end of baseline (8 weeks) and post-intervention (24 weeks)

    ISI is calculated from a questionnaire containing sleep and insomnia related questions

  4. Self-reported pain intensity

    Time frame: 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.

  5. Minutes lightly active

    Time frame: 24 weeks

    Measured by Fitbit

  6. Minutes moderately active

    Time frame: 24 weeks

    Measured by Fitbit

  7. Minutes very active

    Time frame: 24 weeks

    Measured by Fitbit

  8. Sleep efficiency

    Time frame: 24 weeks

    Measured by Fitbit. The formula for sleep efficiency is time asleep/(total time in bed - time to fall asleep)

Study contacts

Contact information is provided by the study sponsor or research team.

Johan Gustav Bellika

CONTACT

[email protected]

+4795748049

Sponsors and collaborators

Lead sponsor

University of Tromso

Other

Collaborators

  • University Hospital of North Norway

Registry information

Official study title

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

Acronym: FIBROSTEPS

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Apr 10, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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