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NCT Number: NCT06487741

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

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.

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Key information

Conditions

Fibromyalgia Adherence, Treatment Behavior Health Behavior Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Stretch Treatment Adherence and Compliance

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College of Northern Denmark

Aalborg, 9220, Denmark

Location status: Recruiting

Location contact

Morten P Støve, PT, Msc.

CONTACT

[email protected]

004522980862

Morten P Støve, PT, Msc.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Home-based stretching exercises

Other

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 outcomes

  1. Severity of symptoms

    Time frame: Measured at baseline

    The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

  2. Severity of symptoms

    Time frame: Measured following 6 weeks of intervention (primary endpoint)

    The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

  3. Severity of symptoms

    Time frame: Measured 6 months after the primary endpoint (secondary endpoint)

    The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score

Secondary outcomes

  1. Health-Related Quality of life (HRQL)

    Time frame: Measured at baseline

    HRQL is assessed using the Danish version of the Short Form-36

  2. Health-Related Quality of life (HRQL)

    Time frame: Measured following 6 weeks of intervention (primary endpoint)

    HRQL is assessed using the Danish version of the Short Form-36

  3. Health-Related Quality of life (HRQL)

    Time frame: Measured 6 months after the primary endpoint (secondary endpoint)

    HRQL is assessed using the Danish version of the Short Form-36

  4. Self-reported physical activity

    Time frame: Measured at baseline

    The International Physical Activity Questionnaire (IPAQ) short form

  5. Self-reported physical activity

    Time frame: Measured following 6 weeks of intervention (primary endpoint)

    The International Physical Activity Questionnaire (IPAQ) short form

  6. Self-reported physical activity

    Time frame: Measured 6 months after the primary endpoint (secondary endpoint)

    The International Physical Activity Questionnaire (IPAQ) short form

  7. Range of motion

    Time frame: Measured at baseline

    Passive knee extension range of motion is assessed using the Biodex System 4 Pro isokinetic dynamometer

  8. Range of motion

    Time frame: Measured following 6 weeks of intervention (primary endpoint)

    Passive knee extension range of motion is assessed using the Biodex System 4 Pro isokinetic dynamometer

  9. Pain sensitivity

    Time frame: Measured at baseline

    Pain sensitivity expressed as pressure pain thresholds are assessed using a handheld electronic pressure algometer

  10. Pain sensitivity

    Time frame: Measured following 6 weeks of intervention (primary endpoint)

    Pain sensitivity expressed as pressure pain thresholds are assessed using a handheld electronic pressure algometer

Other outcomes

  1. Adherence

    Time frame: Measured following 6 weeks of intervention (primary endpoint)

    Adherence to the intervention is evaluated by the number of days stretching is performed using the self-reported data from the mHealth app.

Study contacts

Contact information is provided by the study sponsor or research team.

Allan Riis, PT. Ph.D.

CONTACT

[email protected]

+4572691310

Morten P Støve, PT. Msc.

CONTACT

[email protected]

72691004

Sponsors and collaborators

Lead sponsor

University College of Northern Denmark

Other

Collaborators

  • Aalborg University
  • Bispebjerg Hospital
  • University of Copenhagen

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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