Feasibility and Acceptability of Home-based Stretching Exercises in Fibromyalgia

NCT ID: NCT06176053

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-15

Study Completion Date

2024-05-30

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.

Detailed Description

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Conditions

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Fibromyalgia Pain Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility and acceptability study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Participants were blinded to the results of all measurements and naïve to research hypotheses.

Study Groups

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Regular statict stretching for six weeks

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.

Group Type EXPERIMENTAL

Homebased stretching exercise and app supervision

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role collaborator

University College of Northern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lise Eckardt, Pt. Msc

Role: STUDY_DIRECTOR

Department of Physiotherapy, University College of Northern Denmark

Locations

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University College of Northern Denmark

Aalborg, Select, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 40788404 (View on PubMed)

Other Identifiers

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Feasibility and acceptability

Identifier Type: -

Identifier Source: org_study_id

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