FIBROmyalgia: Somatic Tracking and Exercise Program Study

Not Applicable

Not yet recruiting

• Conditions: Fibromyalgia (FM); Fibromyalgia; Fibromyalgia Syndrome

• Registration Number: NCT06922747
• Lead Sponsor: University of Tromso

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.

Detailed Description

Fibromyalgia is a chronic condition characterised by musculoskeletal pain, fatigue, poor sleep and an overall reduced quality of life. It is well known that physical activity improves symtpons of fibromyalgia, although not all people affected by the condition have positive experiences from exercising. People with fibromyalgia have also stated that physical activity alone is not enough for managing symptomes effectively. This is the background for the proposed randomized controlled trial with a 2\*2 factorial design, where two interventions are tested, alone and in combination.

There will be a baseline period of 8 weeks and an intervention period of 16 weeks.

Evaluations will occur at the end of the baseline period (8 weeks) and at the end of the intervention period (24 weeks).

Study Timeline

• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Study First Posted: 2025-04-10
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-13
• Study Start: 2027-01
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Total FIQ score	At end of baseline (8 weeks) and post-intervention (24 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Resting heart rate	24 weeks	Measured by Fitbit
Insomnia Severity Index (ISI)	At end of baseline (8 weeks) and post-intervention (24 weeks)	ISI is calculated from a questionnaire containing sleep and insomnia related questions
Self-reported pain intensity	24 weeks	Self-reported pain intensity measured by Visual Analogue Scale (VAS). Participants will be asked to register their pain intensity once daily through a mobile application.
Minutes lightly active	24 weeks	Measured by Fitbit
Minutes moderately active	24 weeks	Measured by Fitbit
Minutes very active	24 weeks	Measured by Fitbit
Sleep efficiency	24 weeks	Measured by Fitbit. The formula for sleep efficiency is time asleep/(total time in bed - time to fall asleep)
Steps per day	24 weeks	Measured by Fitbit activity trackers

Trial Locations

Locations (1)

University of Tromsø; 🇳🇴 Tromsø, Troms, Norway