Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-25 @ 2:46 PM
Study NCT ID:
NCT07200050
Status:
COMPLETED
Last Update Posted:
2025-09-30
First Post:
2025-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Home-Based Exercise Program for Fibromyalgia
Sponsor:
Kutahya Health Sciences University
Organization:
Study Overview
Official Title:
Effects of Home-based Exercise Program on Pain, Fatigue, Quality of Life, Depression, and Exercise Perception in Fibromyalgia Patients: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIBRO-EX
Brief Summary:
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:
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).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| FMS-HBEP-2025 | OTHER | Ethics Committee of Kütahya Health Sciences University | View |