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| Name | Class |
|---|---|
| Bispebjerg Hospital | OTHER |
| University of Copenhagen | OTHER |
| Aalborg University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day). |
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| Control | No Intervention | The control group receives usual care, and no change in treatment is made. Participants will be encouraged to maintain their daily routine but refrain from changing the current pharmacological treatment or initiating new physical exercise practices during the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morten P Støve, PT. Msc. | Contact | 72691004 | mps@ucn.dk | |
| Allan Riis, PT. Ph.D. | Contact | +4572691310 | alr@ucn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lise Eckardt, Pt. Msc | Department of Physiotherapy, University College of Northern Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College of Northern Denmark | Recruiting | Aalborg | 9220 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42242521 | Derived | Stove MP, Magnusson SP, Thomsen JL, Riis A. Efficacy of a novel home-based stretching program on fibromyalgia symptoms: a randomised controlled trial. Arch Phys Med Rehabil. 2026 Jun 3:S0003-9993(26)00747-1. doi: 10.1016/j.apmr.2026.05.016. Online ahead of print. | |
| 40016827 | Derived | 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. |
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The study protocol will be published open access. Data is made available upon reasonable request.
The study protocol will be published open access.
Data is made available upon request.
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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Participants are blinded to the results of the pressure pain threshold measurements. Participants and the outcome assessor are blinded to the range of motion measurement results. The outcome assessor (MPS) is blinded to the outcome of the FIQ-R, SF-36 and IPAQ questionnaires.
Blinding participants and the care provider (MPS) from delivering the intervention from treatment allocation is contrary to the nature of the investigated intervention and, therefore, is not considered feasible.
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| 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) |
| D009422 |
| Nervous System Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |