Skip to main content
OpenTrials
Completed

NCT Number: NCT06176053

Feasibility and Acceptability of Home-based Stretching Exercises in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Quality of Life Rheumatic Diseases Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College of Northern Denmark

Aalborg, Select, 9220, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Other outcomes

  1. 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)

  2. 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)

Sponsors and collaborators

Lead sponsor

University College of Northern Denmark

Other

Collaborators

  • Aalborg University
  • Bispebjerg Hospital
  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 19, 2023
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.