Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia; Pain; Quality of Life
• Interventions: Other: Homebased stretching exercise and app supervision

• Registration Number: NCT06176053
• Lead Sponsor: University College of Northern Denmark

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-08
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-19
• Study Start: 2024-02-15
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Regular statict stretching for six weeks	Homebased stretching exercise and app supervision	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.

Primary Outcome Measures

Name	Time	Method
Pressure pain thresholds	Pressure pain thresholds were measured six-weeks after the intervention started	Pressure pain thresholds was measured using a handheld pressure algometer

Secondary Outcome Measures

Name	Time	Method
Health related Quality of Life	Quality of life was measured six-weeks after the intervention started	Quality of life measured by the SF-36 Short Form
Range of motion	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

Trial Locations

Locations (1)

University College of Northern Denmark; 🇩🇰 Aalborg, Select, Denmark