FIBROmyalgia: Somatic Tracking and Exercise Program Study

Sponsor
University of Tromso
Study ID
NCT06922747
Status
Not Yet Recruiting

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Conditions

  • Fibromyalgia
  • Fibromyalgia (FM)
  • Fibromyalgia Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Group exercising — OTHER
    Weekly, supervised exercise sessions in groups
  • Somatic tracking — OTHER
    A psychological intervention aiming to learn the brain to reinterpret pain signals.
  • General activity recommendaitons — OTHER
    General recommendaitons for physical activity and healthy lifestyle

Study Details

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.

Key Dates

First listed
Apr 10, 2025
Start date
Jan 31, 2027
Status verified
May 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group exercising
    Receives weekly supervised group exercise sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.
  • Experimental: Somatic tracking
    Receives weekly sessions of somatic tracking by a certified therapist, a wrist-worn activity tracker, and access to national recommendations on physical activity.
  • Experimental: Group exercising and somatic tracking
    Receives weekly group exercise sessions, weekly somatic tracking sessions, a wrist-worn activity tracker, and access to national recommendations on physical activity.
  • Active Comparator: Control group
    Receives a wrist-worn activity tracker and access to national recommendations on physical activity.

Primary Outcome Measure

Total FIQ score [ Time Frame: At end of baseline (8 weeks) and post-intervention (24 weeks) ]

Central Contacts

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