Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia

NCT06176053 | Completed

• 1 other identifier: Feasibility and acceptability
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Pain; Quality of Life

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Health related Quality of Life

  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 was measured six-weeks after the intervention started

• Range of motion

  Range of motion was measured as a baseline before the participants were instructed in the home exercises

• Range of motion

  Range of motion was measured six-weeks after the intervention started

Other Outcomes (2)

• Fibromyalgia symptoms

  Fibromyalgia symptoms were measured as a baseline before the paticipants are instructed in the home exercises

• Fibromyalgia symptoms

  Fibromyalgia symptoms was measured six-weeks after the intervention started

Study Arms (1)

Regular statict stretching for six weeks

EXPERIMENTAL

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

Interventions

Homebased stretching exercise and app supervision OTHER

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.

Regular statict stretching for six weeks

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College of Northern Denmark: lead
• Bispebjerg Hospital: collaborator
• University of Copenhagen: collaborator
• Aalborg University: collaborator

Study Sites (1)

University College of Northern Denmark

Aalborg, Select, 9220, Denmark

Location

Related Publications (1)

• Stove MP, Larsen LL, Magnusson SP, Thomsen JL, Riis A. Exploring the feasibility, acceptability and preliminary efficacy of a Home-Based stretching program for adults with fibromyalgia: a prospective Pre-Post feasibility study. Rheumatol Int. 2025 Aug 11;45(9):191. doi: 10.1007/s00296-025-05921-4.

  PMID: 40788404 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lise Eckardt, Pt. Msc

  Department of Physiotherapy, University College of Northern Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants were blinded to the results of all measurements and naïve to research hypotheses.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility and acceptability study

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: December 19, 2023
• Study Start: February 15, 2024
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be published.
• Access Criteria: The study protocol will be published open access

Locations

DK (1)