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Home-Based Exercise Program for Fibromyalgia

NCT ID: NCT07200050

Last Updated: 2025-09-30

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-20

Study Completion Date

2022-06-30

Brief Summary

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This study aims to evaluate the effects of a home-based exercise program on patients with fibromyalgia. Participants will be randomly assigned to either an exercise group or a control group. The study will last 12 weeks, and the outcomes will measure improvements in pain, physical function, and quality of life. Participation involves attending scheduled assessments at the Department of Physical Medicine and Rehabilitation, University Hospital. This study helps understand whether a structured home exercise program can benefit individuals with fibromyalgia.

Detailed Description

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Fibromyalgia is a chronic pain syndrome affecting multiple systems, leading to reduced physical function and quality of life. This prospective, randomized, controlled study evaluates the effects of a 12-week home-based exercise program adapted from the Turkish Fibromyalgia Patient Handbook. A total of 60 patients meeting American College of Rheumatology (ACR) 2016 fibromyalgia criteria will be randomly assigned to the exercise or control group. The exercise group will follow a structured home exercise plan, including aerobic, strengthening, and flexibility exercises, while the control group will continue usual care. Outcomes will include pain intensity, physical function (measured by validated scales), and quality of life assessments, evaluated at baseline and after 12 weeks. The study is conducted at the Department of Physical Medicine and Rehabilitation, University Hospital, under ethical approval from the Kutahya Health Sciences University Ethics Committee (Approval No: 2021-02/10, 31 May 2021).

Conditions

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Fibromyalgia

Keywords

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Fibromyalgia Exercise Home-based Pain Quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants were randomly assigned in parallel to either the home-based exercise group or the control group. Both groups were assessed at baseline and after 12 weeks. The study was designed to compare the effects of the exercise program versus usual care on pain, physical function, and quality of life in patients with fibromyalgia
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

No parties were masked in this study

Study Groups

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Home-based Exercise

Participants receive usual care without any additional structured exercise program. Assessments are performed at baseline and after 12 weeks.

Group Type OTHER

Home-based Exercise Program

Intervention Type OTHER

Participants follow a 12-week home-based exercise program including aerobic, strengthening, and flexibility exercises. Assessments are done at baseline and after 12 weeks.

Control

Participants receive usual care without any additional structured exercise program. Assessments are performed at baseline and after 12 weeks.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Home-based Exercise Program

Participants follow a 12-week home-based exercise program including aerobic, strengthening, and flexibility exercises. Assessments are done at baseline and after 12 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 65 years
* Voluntary participation in the study
* Diagnosis of fibromyalgia according to the 2016 ACR criteria
* Female gender
* Pain severity score of ≥4/10 on the Visual Analog Scale (VAS)

Exclusion Criteria

* Pregnancy
* History of malignancy
* Pre-existing neurological, endocrine, infectious, or inflammatory rheumatic diseases
* Severe psychiatric disorders
* Advanced cardiac, respiratory, or musculoskeletal conditions that would prevent exercise
* Participation in an exercise or physical therapy program within the last 6 months
* Any changes to current medical treatment during the study period
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kutahya Health Sciences University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nazlı Karaman, MD

Role: PRINCIPAL_INVESTIGATOR

Kütahya Health Sciences University, Department of Physical Medicine and Rehabilitation

Locations

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Kütahya Health Sciences University Hospital

Kütahya, Kütahya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Home-Based Exercise Study Protocol

View Document

Document Type: Study Protocol and Statistical Analysis Plan: Full Study Protocol

View Document

Study Documents

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Document Type: Individual participant data and supporting information will not be shared.

View Document

Other Identifiers

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FMS-HBEP-2025

Identifier Type: OTHER

Identifier Source: secondary_id

EC-2021-02/10

Identifier Type: -

Identifier Source: org_study_id