Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Acceptability of Home-based Stretching Exercises in Patients With Fibromyalgia

Conditions
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Fibromyalgia, Pain, Quality of Life

Intervention / Treatment
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* Other: Homebased stretching exercise and app supervision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility and acceptability study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regular statict stretching for six weeks<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain thresholds | 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 | 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 | 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 | Quality of life measured by the SF-36 Short Form | 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 | 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 | Range of motion was measured six-weeks after the intervention started |