FibromyalgiaNCT06487741
Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial
A study testing Home-based stretching exercises in people with Fibromyalgia and Stretch, run by University College of Northern Denmark at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fibromyalgia, Stretch, Adherence, Treatment
- What is being tested?
- Home-based stretching exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 31 Oct 2024to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
University College of Northern Denmark
Aalborg, 9220
Morten P Støve, PT, Msc., 004522980862, mps@ucn.dk
Morten P Støve, PT, Msc.
About this study
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.
- Conditions
- Fibromyalgia, Stretch, Adherence, Treatment
- Being tested
- Home-based stretching exercises
- Keywords
- Fibromyalgia, Stretching exercises, Home-based, Adherence
- Medical subject headings
- Fibromyalgia, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based stretching exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day). Receives: Other: Home-based stretching exercises |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of symptoms
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Measured: Measured at baseline
Severity of symptoms
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Measured: Measured following 6 weeks of intervention (primary endpoint)
Severity of symptoms
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Measured: Measured 6 months after the primary endpoint (secondary endpoint)
Secondary outcomes (10)
Health-Related Quality of life (HRQL)
HRQL is assessed using the Danish version of the Short Form-36
Measured: Measured at baseline
Health-Related Quality of life (HRQL)
HRQL is assessed using the Danish version of the Short Form-36
Measured: 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: Measured 6 months after the primary endpoint (secondary endpoint)
Self-reported physical activity
The International Physical Activity Questionnaire (IPAQ) short form
Measured: Measured at baseline
Self-reported physical activity
The International Physical Activity Questionnaire (IPAQ) short form
Measured: Measured following 6 weeks of intervention (primary endpoint)
Self-reported physical activity
The International Physical Activity Questionnaire (IPAQ) short form
Measured: 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: Measured at baseline
Range of motion
Passive knee extension range of motion is assessed using the Biodex System 4 Pro isokinetic dynamometer
Measured: 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: Measured at baseline
Pain sensitivity
Pain sensitivity expressed as pressure pain thresholds are assessed using a handheld electronic pressure algometer
Measured: Measured following 6 weeks of intervention (primary endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start31 Oct 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Copenhagen, Aalborg University
- Responsible party
- Sponsor
- Investigators
- Lise Eckardt, Pt. Msc, Study director, Department of Physiotherapy, University College of Northern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487741
- Sponsor's protocol ID
- Fibromyalgia RCT
- Status last verified
- Nov 2024
- First submitted
- 27 Jun 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be published open access. Data is made available upon reasonable request.
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.
PubMed 40016827
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Home-based Stretching Program on Fibromyalgia Symptoms: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06487741
- Acronym / sponsor ID
- Fibromyalgia RCT
- Conditions
- Fibromyalgia, Stretch, Adherence, Treatment
- Keywords
- Fibromyalgia, Stretching exercises, Home-based, Adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Copenhagen, Aalborg University
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Home-based stretching exercisesThe intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day). |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based stretching exercisesThe 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. | Other | Intervention |
Primary outcome
Severity of symptoms
Time frame: Measured at baseline
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Severity of symptoms
Time frame: Measured following 6 weeks of intervention (primary endpoint)
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Severity of symptoms
Time frame: Measured 6 months after the primary endpoint (secondary endpoint)
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
10 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 40016827Stove 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.
- Individual participant dataSharing planned: Yes. The study protocol will be published open access. Data is made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lise Eckardt, Pt. Msc study director
Department of Physiotherapy, University College of Northern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based stretching exercises in people with Fibromyalgia and Stretch, run by University College of Northern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morten P Støve, PT. Msc. (72691004, mps@ucn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of symptoms (time frame: Measured at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06487741, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.