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

February 12, 2025 updated by: University College of Northern Denmark
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Allan Riis, PT. Ph.D.
  • Phone Number: +4572691310
  • Email: alr@ucn.dk

Study Contact Backup

  • Name: Morten P Støve, PT. Msc.
  • Phone Number: 72691004
  • Email: mps@ucn.dk

Study Locations

  • Denmark
      • Aalborg, Denmark, 9220
        • Recruiting
        • University College of Northern Denmark
        • Contact:
          • Morten P Støve, PT, Msc.
          • Phone Number: 004522980862
          • Email: mps@ucn.dk
        • Principal Investigator:
          • Morten P Støve, PT, Msc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
The intervention group receives a home-based rehabilitation program consisting of six weeks of daily static stretching exercises (six minutes a day).
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.
No Intervention: Control
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severity of symptoms
Time Frame: Measured at baseline
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Measured at baseline
Severity of symptoms
Time Frame: Measured following 6 weeks of intervention (primary endpoint)
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Measured following 6 weeks of intervention (primary endpoint)
Severity of symptoms
Time Frame: Measured 6 months after the primary endpoint (secondary endpoint)
The Revised Fibromyalgia Impact Questionnaire (FIQ-R) total score
Measured 6 months after the primary endpoint (secondary endpoint)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health-Related Quality of life (HRQL)
Time Frame: Measured at baseline
HRQL is assessed using the Danish version of the Short Form-36
Measured at baseline
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
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)
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
Time Frame: Measured at baseline
The International Physical Activity Questionnaire (IPAQ) short form
Measured at baseline
Self-reported physical activity
Time Frame: Measured following 6 weeks of intervention (primary endpoint)
The International Physical Activity Questionnaire (IPAQ) short form
Measured following 6 weeks of intervention (primary endpoint)
Self-reported physical activity
Time Frame: Measured 6 months after the primary endpoint (secondary endpoint)
The International Physical Activity Questionnaire (IPAQ) short form
Measured 6 months after the primary endpoint (secondary endpoint)
Range of motion
Time Frame: Measured at baseline
Passive knee extension range of motion is assessed using the Biodex System 4 Pro isokinetic dynamometer
Measured at baseline
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
Measured following 6 weeks of intervention (primary endpoint)
Pain sensitivity
Time Frame: Measured at baseline
Pain sensitivity expressed as pressure pain thresholds are assessed using a handheld electronic pressure algometer
Measured at baseline
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
Measured following 6 weeks of intervention (primary endpoint)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Measured following 6 weeks of intervention (primary endpoint)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College of Northern Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Copenhagen
Bispebjerg Hospital
Aalborg University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Lise Eckardt, Pt. Msc, Department of Physiotherapy, University College of Northern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fibromyalgia RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study protocol will be published open access. Data is made available upon reasonable request.

IPD Sharing Time Frame

The study protocol will be published open access.

IPD Sharing Access Criteria

Data is made available upon request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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