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FIBROmyalgia: Somatic Tracking and Exercise Program Study

ConditionsFibromyalgia (FM)FibromyalgiaFibromyalgia Syndrome
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

This trial does not accept healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

  • Group exercising

    Other intervention

    Weekly, supervised exercise sessions in groups

  • Somatic tracking

    Other intervention

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

  • General activity recommendaitons

    Other intervention

    General recommendaitons for physical activity and healthy lifestyle

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Group exercisingExperimental treatment 1 intervention
Group B: Somatic trackingExperimental treatment 1 intervention
Group C: Group exercising and somatic trackingExperimental treatment 2 interventions
Group D: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total FIQ score

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.

Time frame
At end of baseline (8 weeks) and post-intervention (24 weeks)

Secondary outcomes

1

Steps per day

Measured by Fitbit activity trackers

Time frame
24 weeks
2

Resting heart rate

Measured by Fitbit

Time frame
24 weeks
3

Insomnia Severity Index (ISI)

ISI is calculated from a questionnaire containing sleep and insomnia related questions

Time frame
At end of baseline (8 weeks) and post-intervention (24 weeks)
4

Self-reported pain intensity

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.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Tromso

Lead sponsor

University Hospital of North Norway

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: