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Clinical Trials in Norway / NCT06922747
Starting soon Not applicable

FIBROmyalgia: Somatic Tracking and Exercise Program Study

NCT06922747 · tracked via the Priya Life Science Norway tracker
Sponsor
University of Tromso
Phase
Not applicable
Started
2027-01
Last updated
2025-05-13

Condition(s) studied

Fibromyalgia (FM)FibromyalgiaFibromyalgia Syndrome

Investigational drug(s) / intervention(s)

Group exercisingSomatic trackingGeneral activity recommendaitons

Group exercising: Weekly, supervised exercise sessions in groups

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

General activity recommendaitons: General recommendaitons for physical activity and healthy lifestyle

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University of Tromsø Tromsø Troms

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06922747 on ClinicalTrials.gov ↗ ← All trials in Norway