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NOT YET RECRUITING
NCT06922747
NA

FIBROmyalgia: Somatic Tracking and Exercise Program Study

Sponsor: University of Tromso

View on ClinicalTrials.gov

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.

Official title: FIBROSTEPS Protocol: A 2×2 Factorial Randomized Controlled Trial Evaluating Group Exercise and Somatic Tracking in Fibromyalgia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2027-01

Completion Date

2028-01

Last Updated

2025-05-13

Healthy Volunteers

No

Interventions

OTHER

Group exercising

Weekly, supervised exercise sessions in groups

OTHER

Somatic tracking

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

OTHER

General activity recommendaitons

General recommendaitons for physical activity and healthy lifestyle

Locations (1)

University of Tromsø

Tromsø, Troms, Norway