Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial
NCT Number: NCT06487741
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Fibromyalgia|Stretch|Adherence, Treatment
Interventions: OTHER: Home-based stretching exercises
Sponsor: University College of Northern Denmark
Collaborators: Bispebjerg Hospital|University of Copenhagen|Center for General Practice at Aalborg University
Sex: ALL
Age: ADULT
Enrollment: 58
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2026-08-30

Summary:
This randomised controlled trial will examine the clinical efficacy of a six-week, novel, home-based stretching programme compared to usual care on the effect of symptoms experienced by patients with fibromyalgia.

Primary Outcome Measures: Severity of symptoms, The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score, Measured at baseline|Severity of symptoms, The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score, Measured following 6 weeks of intervention (primary endpoint)|Severity of symptoms, The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score, Measured 6 months after the primary endpoint (secondary endpoint)
Secondary Outcome Measures: Health-Related Quality of life (HRQL), HRQL is assessed using the Danish version of the Short Form-36, Measured at baseline|Health-Related Quality of life (HRQL), HRQL is assessed using the Danish version of the Short Form-36, Measured following 6 weeks of intervention (primary endpoint)|Health-Related Quality of life (HRQL), HRQL is assessed using the Danish version of the Short Form-36, Measured 6 months after the primary endpoint (secondary endpoint)|Self-reported physical activity, The International Physical Activity Questionnaire (IPAQ) short form, Measured at baseline|Self-reported physical activity, The International Physical Activity Questionnaire (IPAQ) short form, Measured following 6 weeks of intervention (primary endpoint)|Self-reported physical activity, The International Physical Activity Questionnaire (IPAQ) short form, Measured 6 months after the primary endpoint (secondary endpoint)|Range of motion, Passive knee extension range of motion is assessed using the Biodex System 4 Pro isokinetic dynamometer, Measured at baseline|Range of motion, Passive knee extension range of motion is assessed using the Biodex System 4 Pro isokinetic dynamometer, Measured following 6 weeks of intervention (primary endpoint)|Pain sensitivity, Pain sensitivity expressed as pressure pain thresholds are assessed using a handheld electronic pressure algometer, Measured at baseline|Pain sensitivity, Pain sensitivity expressed as pressure pain thresholds are assessed using a handheld electronic pressure algometer, Measured following 6 weeks of intervention (primary endpoint)
Other Outcome Measures: Adherence, Adherence to the intervention is evaluated by the number of days stretching is performed using the self-reported data from the mHealth app., Measured following 6 weeks of intervention (primary endpoint)