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FIBROmyalgia: Somatic Tracking and Exercise Program Study

NCT06922747 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-05-13

No results posted yet for this 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.

Conditions

  • Fibromyalgia (FM)
  • Fibromyalgia
  • Fibromyalgia Syndrome

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

Sponsors & Collaborators

  • University Hospital of North Norway

    collaborator OTHER

  • University of Tromso

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922747 on ClinicalTrials.gov