Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06176053
• Other study ID #: Feasibility and acceptability
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: University College of Northern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: November 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Pain
• Quality of Life

Intervention

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.

Locations

Country	Name	City	State
Denmark	University College of Northern Denmark	Aalborg	Select

Sponsors (4)

Lead Sponsor	Collaborator
University College of Northern Denmark	Bispebjerg Hospital, Center for General Practice at Aalborg University, University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fibromyalgia symptoms	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
Other	Fibromyalgia symptoms	Fibromyalgia symptoms were measure using the The Revised Fibromyalgia Impact Questionnaire (FIQR)	Fibromyalgia symptoms was measured six-weeks after the intervention started
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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