FIBROmyalgia: Somatic Tracking and Exercise Program Study (FIBROSTEPS)

University of Tromso (UiT)

Status: Begins enrollment in 10 months

Conditions: Fibromyalgia; Fibromyalgia (FM); Fibromyalgia Syndrome

Treatments: Other: Group exercising; Other: Somatic tracking; Other: General activity recommendaitons

Study type: Interventional

Funder types: Other

Identifiers

NCT06922747

University of Tromso (Other Identifier)

2025/853403(REK)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Group exercising

Experimental group

Description:

Receives weekly supervised group exercise sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.

Treatment:

Other: Group exercising

Somatic tracking

Experimental group

Description:

Receives weekly sessions of somatic tracking by a certified therapist, a wrist-worn activity tracker, and access to national recommendations on physical activity.

Treatment:

Other: Somatic tracking

Group exercising and somatic tracking

Experimental group

Description:

Receives weekly group exercise sessions, weekly somatic tracking sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.

Treatment:

Other: Somatic tracking

Other: Group exercising

Control group

Active Comparator group

Description:

Receives a wrist-worn activity tracker and access to national recommendations on physical activity.

Treatment:

Other: General activity recommendaitons