Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia

June 27, 2024 updated by: University College of Northern Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • 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 Locations

  • Denmark
    • Select
      • Aalborg, Select, Denmark, 9220
        • University College of Northern Denmark

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Regular statict stretching for six weeks
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.
Other: Homebased stretching exercise and app supervision
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 were measured as a baseline before the participants are instructed in the home exercises
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
Pressure pain thresholds were measured six-weeks after the intervention started

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related Quality of Life
Time Frame: Quality of life was measured as a baseline before the paticipants are instructed in the home exercises
Quality of life measured by the SF-36 Short Form
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
Quality of life measured by the SF-36 Short Form
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
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
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
Passive knee extension range of motion measured by the Biodex system 4 pro isokinetic dynamometer
Range of motion was measured six-weeks after the intervention started

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fibromyalgia symptoms
Time Frame: Fibromyalgia symptoms were measured as a baseline before the paticipants are instructed in the home exercises
Fibromyalgia symptoms were measure using the The Revised Fibromyalgia Impact Questionnaire (FIQR)
Fibromyalgia symptoms were measured as a baseline before the paticipants are instructed in the home exercises
Fibromyalgia symptoms
Time Frame: Fibromyalgia symptoms was measured six-weeks after the intervention started
Fibromyalgia symptoms were measure using the The Revised Fibromyalgia Impact Questionnaire (FIQR)
Fibromyalgia symptoms was measured six-weeks after the intervention started

Collaborators and Investigators

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

Sponsor

University College of Northern Denmark

Collaborators

University of Copenhagen
Bispebjerg Hospital
Center for General Practice at Aalborg University

Investigators

  • 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)

February 15, 2024

Primary Completion (Actual)

May 30, 2024

Study Completion (Actual)

May 30, 2024

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 19, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Feasibility and acceptability

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data is made available upon request.

IPD Sharing Time Frame

The study protocol will be published.

IPD Sharing Access Criteria

The study protocol will be published open access

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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