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Recruiting NCT06487741

Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial

No phase Interventional Fibromyalgia Stretch Adherence, Treatment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home-based stretching exercises.
Who it may be relevant to
Registry conditions: Fibromyalgia, Stretch, Adherence, Treatment. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Home-based stretching exercises
    The intervention comprises six weeks of daily static stretching exercises (six minutes a day) in accordance with the recommendation of the American College of Sports Medicine. The intervention is self-administered and consists of two bouts of 30-second bilateral static stretches of the knee flexors, hip abductors, and shoulder elevators.

Primary outcome measures

  • Severity of symptoms [Time frame: Measured at baseline]
  • Severity of symptoms [Time frame: Measured following 6 weeks of intervention (primary endpoint)]
  • Severity of symptoms [Time frame: Measured 6 months after the primary endpoint (secondary endpoint)]
Secondary outcome measures (10)
  • Health-Related Quality of life (HRQL) [Time frame: Measured at baseline]
  • Health-Related Quality of life (HRQL) [Time frame: Measured following 6 weeks of intervention (primary endpoint)]
  • Health-Related Quality of life (HRQL) [Time frame: Measured 6 months after the primary endpoint (secondary endpoint)]
  • Self-reported physical activity [Time frame: Measured at baseline]
  • Self-reported physical activity [Time frame: Measured following 6 weeks of intervention (primary endpoint)]
  • Self-reported physical activity [Time frame: Measured 6 months after the primary endpoint (secondary endpoint)]
  • Range of motion [Time frame: Measured at baseline]
  • Range of motion [Time frame: Measured following 6 weeks of intervention (primary endpoint)]
  • Pain sensitivity [Time frame: Measured at baseline]
  • Pain sensitivity [Time frame: Measured following 6 weeks of intervention (primary endpoint)]

Eligibility criteria

Inclusion criteria

  • individuals diagnosed with fibromyalgia in accordance with the ACR 2016 diagnostic criteria.
  • individuals diagnosed with chronic non-malignant pain or individuals diagnosed with chronic widespread pain (including fibromyalgia syndrome) are also included when they meet the ACR 2016 diagnostic criteria.

Exclusion criteria

  • Non-controlled systemic disorders (such as hypertension, diabetes and coronary insufficiency),
  • neurological conditions that impair alertness or comprehension, musculoskeletal conditions that could compromise assessments (such as nerve root compression or knee joint inflammation),
  • relevant joint disorders (such as severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis),
  • recent changes in therapy for fibromyalgia (i.e., within four weeks of baseline).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • University College of Northern Denmark — Aalborg

Publications

  • Stove MP, Magnusson SP, Thomsen JL, Riis A. Efficacy of a home-based stretching programme on fibromyalgia symptoms: study protocol for a randomised controlled trial. Trials. 2025 Feb 27;26(1):74. doi: 10.1186/s13063-025-08776-z. PMID 40016827

Identifiers

NCT: NCT06487741 · Fibromyalgia RCT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗