FIBROmyalgia: Somatic Tracking and Exercise Program Study

NCT ID: NCT06922747

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2027-01-31
• Study Completion Date: 2028-01-31

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).

Conditions

Fibromyalgia (FM); Fibromyalgia; Fibromyalgia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group exercising

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

Group Type: EXPERIMENTAL

Group exercising

Intervention Type: OTHER

Weekly, supervised exercise sessions in groups

Somatic tracking

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

Group Type: EXPERIMENTAL

Somatic tracking

Intervention Type: OTHER

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

Group exercising and somatic tracking

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

Group Type: EXPERIMENTAL

Group exercising

Intervention Type: OTHER

Weekly, supervised exercise sessions in groups

Somatic tracking

Intervention Type: OTHER

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

Control group

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

Group Type: ACTIVE_COMPARATOR

General activity recommendaitons

Intervention Type: OTHER

General recommendaitons for physical activity and healthy lifestyle

Interventions

Group exercising

Weekly, supervised exercise sessions in groups

Intervention Type: OTHER

Somatic tracking

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

Intervention Type: OTHER

General activity recommendaitons

General recommendaitons for physical activity and healthy lifestyle

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Tromsø

Tromsø, Troms, Norway

Countries

Norway

Central Contacts

Johan Gustav Bellika

Role: CONTACT

Johan.Gustav.Bellika@ehealthresearch.no

+4795748049

Other Identifiers

University of Tromso

Identifier Type: OTHER

Identifier Source: secondary_id

2025/853403(REK)

Identifier Type: -

Identifier Source: org_study_id