FIBROmyalgia: Somatic Tracking and Exercise Program Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Tromso

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Pregnant

Severe co-morbid psychiatric or neurological disorders

Current participation in another clinical trial

Recent surgery or other physical constraints preventing exercise

Trial design

Treatments tested in this trial

  • Group exercising
  • Somatic tracking
  • General activity recommendaitons

Treatment groups

200 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Tromso

Lead sponsor

University Hospital of North Norway

Collaborator