Fibromyalgia (FM)FIBROSTEPSNCT06922747
FIBROmyalgia: Somatic Tracking and Exercise Program Study
A study testing Group exercising, Somatic tracking and General activity recommendaitons in people with Fibromyalgia (FM) and Fibromyalgia, run by University of Tromso at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia (FM), Fibromyalgia, Fibromyalgia Syndrome
- What is being tested?
- Group exercising, Somatic tracking and General activity recommendaitons
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2027to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant
- Severe co-morbid psychiatric or neurological disorders
- Current participation in another clinical trial
- Recent surgery or other physical constraints preventing exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read more
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.
Read the 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
- Being tested
- Group exercising, Somatic tracking, General activity recommendaitons
- 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
- Medical subject headings
- Fibromyalgia, Motor Activity, Pain, Musculoskeletal Pain, Rheumatic Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group exercisingOther
Weekly, supervised exercise sessions in groups
Somatic trackingOther
A psychological intervention aiming to learn the brain to reinterpret pain signals.
General activity recommendaitonsOther
General recommendaitons for physical activity and healthy lifestyle
| Study group | Role | What they receive |
|---|---|---|
| Group exercising | Experimental | Receives weekly supervised group exercise sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity. Receives: Other: Group exercising |
| Somatic tracking | Experimental | Receives weekly sessions of somatic tracking by a certified therapist, a wrist-worn activity tracker, and access to national recommendations on physical activity. Receives: Other: Somatic tracking |
| Group exercising and somatic tracking | Experimental | Receives weekly group exercise sessions, weekly somatic tracking sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity. Receives: Other: Group exercising; Other: Somatic tracking |
| Control group | Active comparator | Receives a wrist-worn activity tracker and access to national recommendations on physical activity. Receives: Other: General activity recommendaitons |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At end of baseline (8 weeks) and post-intervention (24 weeks)
Secondary outcomes (8)
Steps per day
Measured by Fitbit activity trackers
Measured: 24 weeks
Resting heart rate
Measured by Fitbit
Measured: 24 weeks
Insomnia Severity Index (ISI)
ISI is calculated from a questionnaire containing sleep and insomnia related questions
Measured: At end of baseline (8 weeks) and post-intervention (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.
Measured: 24 weeks
Minutes lightly active
Measured by Fitbit
Measured: 24 weeks
Minutes moderately active
Measured by Fitbit
Measured: 24 weeks
Minutes very active
Measured by Fitbit
Measured: 24 weeks
Sleep efficiency
Measured by Fitbit. The formula for sleep efficiency is time asleep/(total time in bed - time to fall asleep)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibromyalgia (FM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The trial applies a 2\*2 factorial design.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of North Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922747
- Sponsor's protocol ID
- 2025/853403(REK)
- Other IDs
- University of Tromso, 2025
- Acronym
- FIBROSTEPS
- Status last verified
- May 2025
- First submitted
- 3 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FIBROSTEPS Protocol: A 2×2 Factorial Randomized Controlled Trial Evaluating Group Exercise and Somatic Tracking in Fibromyalgia
- ClinicalTrials.gov ID
- NCT06922747
- Acronym / sponsor ID
- FIBROSTEPS / 2025/853403(REK)
- Conditions
- Fibromyalgia (FM), Fibromyalgia, Fibromyalgia Syndrome
- Keywords
- fibromyalgia impact questionnaire, randomized controlled trial, clinical trial, factorial design, 2*2 factorial design, physical activity, somatic tracking, activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Collaborators
- University Hospital of North Norway
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The trial applies a 2*2 factorial design.
| Arm | Type | Receives |
|---|---|---|
| Group exercising | Experimental | Other: Group exercisingReceives weekly supervised group exercise sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity. |
| Somatic tracking | Experimental | Other: Somatic trackingReceives 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 trackingReceives 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 recommendaitonsReceives a wrist-worn activity tracker and access to national recommendations on physical activity. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Pregnant
- Severe co-morbid psychiatric or neurological disorders
- Current participation in another clinical trial
- Recent surgery or other physical constraints preventing exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group exercisingWeekly, supervised exercise sessions in groups | Other | Group exercising, Group exercising and somatic tracking |
| Somatic trackingA psychological intervention aiming to learn the brain to reinterpret pain signals. | Other | Group exercising and somatic tracking, Somatic tracking |
| General activity recommendaitonsGeneral recommendaitons for physical activity and healthy lifestyle | Other | Control group |
Primary outcome
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.
8 secondary outcomes
Steps per day
Time frame: 24 weeks
Resting heart rate
Time frame: 24 weeks
Insomnia Severity Index (ISI)
Time frame: At end of baseline (8 weeks) and post-intervention (24 weeks)
Self-reported pain intensity
Time frame: 24 weeks
Minutes lightly active
Time frame: 24 weeks
Minutes moderately active
Time frame: 24 weeks
Minutes very active
Time frame: 24 weeks
Sleep efficiency
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group exercising, Somatic tracking and General activity recommendaitons in people with Fibromyalgia (FM) and Fibromyalgia, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Gustav Bellika (+4795748049, Johan.Gustav.Bellika@ehealthresearch.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total FIQ score (time frame: At end of baseline (8 weeks) and post-intervention (24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.