FIBROmyalgia: Somatic Tracking and Exercise Program Study

NCT06922747 | Not Yet Recruiting DMC

• 2 other identifiers: 2025/853403(REK)University of Tromso
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (8)

• Steps per day

  24 weeks

• Resting heart rate

  24 weeks

• Insomnia Severity Index (ISI)

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

• Self-reported pain intensity

  24 weeks

• Minutes lightly active

  24 weeks

Study Arms (4)

Group exercising

EXPERIMENTAL

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

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.

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.

Other: Group exercising; Other: Somatic tracking

Control group

ACTIVE COMPARATOR

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

Other: General activity recommendaitons

Interventions

Group exercising OTHER

Weekly, supervised exercise sessions in groups

Group exercising; Group exercising and somatic tracking

Somatic tracking OTHER

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

Group exercising and somatic tracking; Somatic tracking

General activity recommendaitons OTHER

General recommendaitons for physical activity and healthy lifestyle

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant
• Severe co-morbid psychiatric or neurological disorders
• Current participation in another clinical trial
• Recent surgery or other physical constraints preventing exercise

Sponsors & Collaborators

• University of Tromso: lead
• University Hospital of North Norway: collaborator

Study Sites (1)

University of Tromsø

Tromsø, Troms, 9019, Norway

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Pain; Musculoskeletal Pain; Rheumatic Diseases; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Johan Gustav Bellika

CONTACT

+4795748049; Johan.Gustav.Bellika@ehealthresearch.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial applies a 2\*2 factorial design.

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)