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Search / Trial NCT06922747

FIBROmyalgia: Somatic Tracking and Exercise Program Study

Launched by UNIVERSITY OF TROMSO · Apr 3, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Fibromyalgia Impact Questionnaire Randomized Controlled Trial Clinical Trial Factorial Design 2*2 Factorial Design Physical Activity Somatic Tracking Activity Fibromyalgia Pain Effect Study Musculoskeletal Pain Rheumatic Diseases Musculoskeletal Diseases

ClinConnect Summary

This clinical trial is studying how effective a combination of exercise and therapy is for treating fibromyalgia (FM) symptoms compared to just exercise or general activity recommendations. The researchers want to find out if doing group exercise sessions together with consultations from a therapist helps people feel better than just exercising alone. Participants in the study will be adults aged 18 to 65 who have been diagnosed with fibromyalgia. They will wear activity trackers to monitor their movement, record their pain levels daily using a mobile app, and complete a questionnaire about how fibromyalgia affects their lives.

To be eligible, participants should be able to do light physical activity and have a smartphone. They cannot be pregnant or have certain serious health conditions. The study will last a total of 24 weeks, with an initial 8-week period where participants maintain their usual lifestyle before starting the interventions. They will be divided into four groups: one for exercise only, one for therapy only, one for both, and one for general activity recommendations. This research aims to better understand how these different approaches can help manage fibromyalgia symptoms.

Gender

ALL

Eligibility criteria

  • 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

About University Of Tromso

The University of Tromsø, located in Norway, is an esteemed academic institution renowned for its commitment to research and innovation in various fields, including health sciences. As a clinical trial sponsor, the university leverages its cutting-edge facilities and interdisciplinary expertise to advance medical research, enhance patient care, and contribute to scientific knowledge. With a strong emphasis on ethical standards and regulatory compliance, the University of Tromsø collaborates with healthcare professionals and researchers to design and implement clinical trials that address critical health challenges, ultimately aiming to improve health outcomes and inform clinical practices.

Locations

Tromsø, Troms, Norway

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported