FibromyalgiaNCT06176053
Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia
A study testing Homebased stretching exercise and app supervision in people with Fibromyalgia and Pain, run by University College of Northern Denmark at 1 site in Denmark.
Trial summary
The study aims to gather knowledge about the patient's acceptance of the intervention and testing procedures, assess the adherence to the intervention, estimate the recruitment rate, and inform the sample size calculation for a subsequent randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Fibromyalgia, Pain, Quality of Life
- What is being tested?
- Homebased stretching exercise and app supervision
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2024to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients are included if they are aged 18 to 55 years and diagnosed with fibromyalgia in accordance with the American College of Rheumatology (ACR) criteria
Who cannot join
- Non-controlled systemic disorders
- Impaired alertness or comprehension
- relevant joint disorders (e.g., severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis)
- recent changes in therapy
- neurological and musculoskeletal conditions that could compromise assessments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of Home-based Stretching Exercises in Patients With Fibromyalgia
The study aims to gather knowledge about the patient's acceptance of the intervention and testing procedures, assess the adherence to the intervention, estimate the recruitment rate, and inform the sample size calculation for a subsequent randomized controlled trial.
- Conditions
- Fibromyalgia, Pain, Quality of Life
- Being tested
- Homebased stretching exercise and app supervision
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Homebased stretching exercise and app supervisionOther
The intervention group will perform a self-administered, home-based stretching program (a total of 6 minutes per day) and maintain their daily activities as identified at baseline. Exercises are to be performed daily for six weeks. Adherence will be supported, and weekly contact with each participant will be maintained via a mHealth application.
| Study group | Role | What they receive |
|---|---|---|
| Regular statict stretching for six weeks | Experimental | Twelve patients aged 18-65, diagnosed with fibromyalgia, will be recruited to participate in a six-week, supervised, home-based stretching program. Exercises are to be performed daily (6 minutes per day) for six weeks. Adherence will be supported, and weekly contact with each participant will be maintained via a mHealth application. Receives: Other: Homebased stretching exercise and app supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain thresholds
Pressure pain thresholds was measures using a handheld pressure algometer
Measured: Pressure pain thresholds were measured as a baseline before the participants are instructed in the home exercises
Pressure pain thresholds
Pressure pain thresholds was measured using a handheld pressure algometer
Measured: Pressure pain thresholds were measured six-weeks after the intervention started
Secondary outcomes (4)
Health related Quality of Life
Quality of life measured by the SF-36 Short Form
Measured: Quality of life was measured as a baseline before the paticipants are instructed in the home exercises
Health related Quality of Life
Quality of life measured by the SF-36 Short Form
Measured: Quality of life was measured six-weeks after the intervention started
Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Measured: Range of motion was measured as a baseline before the participants were instructed in the home exercises
Range of motion
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Measured: Range of motion was measured six-weeks after the intervention started
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start15 Feb 2024
- Primary completion30 May 2024
- Study completion30 May 2024
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
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility and acceptability study
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT06176053
- Sponsor's protocol ID
- Feasibility and acceptability
- Status last verified
- Jun 2024
- First submitted
- 8 Dec 2023
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is made available upon request.
Publications
Stove MP, Larsen LL, Magnusson SP, Thomsen JL, Riis A. Exploring the feasibility, acceptability and preliminary efficacy of a Home-Based stretching program for adults with fibromyalgia: a prospective Pre-Post feasibility study. Rheumatol Int. 2025 Aug 11;45(9):191. doi: 10.1007/s00296-025-05921-4.
PubMed 40788404
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Home-based Stretching Exercises in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT06176053
- Acronym / sponsor ID
- Feasibility and acceptability
- Conditions
- Fibromyalgia, Pain, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital, University of Copenhagen, Aalborg University
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 19 Dec 2023 (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.
The study aims to gather knowledge about the patient's acceptance of the intervention and testing procedures, assess the adherence to the intervention, estimate the recruitment rate, and inform the sample size calculation for a subsequent randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility and acceptability study
| Arm | Type | Receives |
|---|---|---|
| Regular statict stretching for six weeks | Experimental | Other: Homebased stretching exercise and app supervisionTwelve patients aged 18-65, diagnosed with fibromyalgia, will be recruited to participate in a six-week, supervised, home-based stretching program. Exercises are to be performed daily (6 minutes per day) for six weeks. Adherence will be supported, and weekly contact with each participant will be maintained via a mHealth application. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients are included if they are aged 18 to 55 years and diagnosed with fibromyalgia in accordance with the American College of Rheumatology (ACR) criteria
Key exclusion criteria (5 listed)
- Non-controlled systemic disorders
- Impaired alertness or comprehension
- relevant joint disorders (e.g., severe arthritis, arthroplasty of the hip or knee, and rheumatoid arthritis)
- recent changes in therapy
- neurological and musculoskeletal conditions that could compromise assessments
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 |
|---|---|---|
| Homebased stretching exercise and app supervisionThe intervention group will perform a self-administered, home-based stretching program (a total of 6 minutes per day) and maintain their daily activities as identified at baseline. Exercises are to be performed daily for six weeks. Adherence will be supported, and weekly contact with each participant will be maintained via a mHealth application. | Other | Regular statict stretching for six weeks |
Primary outcome
Pressure pain thresholds
Time frame: Pressure pain thresholds were measured as a baseline before the participants are instructed in the home exercises
Pressure pain thresholds was measures using a handheld pressure algometer
Pressure pain thresholds
Time frame: Pressure pain thresholds were measured six-weeks after the intervention started
Pressure pain thresholds was measured using a handheld pressure algometer
4 secondary outcomes
Health related Quality of Life
Time frame: Quality of life was measured as a baseline before the paticipants are instructed in the home exercises
Health related Quality of Life
Time frame: Quality of life was measured six-weeks after the intervention started
Range of motion
Time frame: Range of motion was measured as a baseline before the participants were instructed in the home exercises
Range of motion
Time frame: Range of motion was measured six-weeks after the intervention started
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Derived from this study: PubMed 40788404Stove MP, Larsen LL, Magnusson SP, Thomsen JL, Riis A. Exploring the feasibility, acceptability and preliminary efficacy of a Home-Based stretching program for adults with fibromyalgia: a prospective Pre-Post feasibility study. Rheumatol Int. 2025 Aug 11;45(9):191. doi: 10.1007/s00296-025-05921-4.
- Individual participant dataSharing planned: Yes. Data is made available upon request.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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. This study is not recruiting at the moment.
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 Homebased stretching exercise and app supervision in people with Fibromyalgia and Pain, 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 28 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain thresholds (time frame: Pressure pain thresholds were measured as a baseline before the participants are instructed in the home exercises). The study lists 2 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 NCT06176053, 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 28 Jun 2024.