Clinical trial NCT06922747: FIBROmyalgia: Somatic Tracking and Exercise Program Study
Official title: FIBROSTEPS Protocol: A 2×2 Factorial Randomized Controlled Trial Evaluating Group Exercise and Somatic Tracking in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
fibromyalgia
pain
effect study
musculoskeletal pain
rheumatic diseases
musculoskeletal diseases
Lead sponsor: University of Tromso
Sponsor class: OTHER
Collaborators: name: University Hospital of North Norway
First posted: 2025-04-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The trial applies a 2\*2 factorial design.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Total FIQ score
timeFrame: At end of baseline (8 weeks) and post-intervention (24 weeks)
Secondary outcomes:
measure: Steps per day
timeFrame: 24 weeks
measure: Resting heart rate
timeFrame: 24 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: At end of baseline (8 weeks) and post-intervention (24 weeks)
measure: Self-reported pain intensity
timeFrame: 24 weeks
measure: Minutes lightly active
timeFrame: 24 weeks
measure: Minutes moderately active
timeFrame: 24 weeks
measure: Minutes very active
timeFrame: 24 weeks
measure: Sleep efficiency
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University of Tromsø
state: Troms
Study officials:
References: