Home-Based Exercise Program for Fibromyalgia

NCT07200050 | Completed

• 2 other identifiers: EC-2021-02/10FMS-HBEP-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Exercise; Home-based; Pain; Quality of life

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity (Visual Analog Scale, VAS)

  Change in pain intensity from baseline to week 12 measured by the Visual Analog Scale (VAS).The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates unbearable pain. Higher scores indicate worse pain.

  12 weeks

Secondary Outcomes (4)

• Change in quality of life (Fibromyalgia Impact Questionnaire, FIQ)

  12 weeks

• Change in fatigue severity (Visual Analog Scale, VAS)

  12 weeks

• Change in depressive symptoms (Beck Depression Inventory, BDI)

  12 weeks

• Change in exercise perception (Exercise Benefits and Barriers Scale, EBBS)

  12 weeks

Study Arms (2)

Home-based Exercise

OTHER

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

Other: Home-based Exercise Program

Control

NO INTERVENTION

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

Interventions

Home-based Exercise Program 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.

Home-based Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Only female participants (biological sex: female) with fibromyalgia are eligible to participate.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kütahya Health Sciences University Hospital

Kütahya, Kütahya, 43290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Nazlı Karaman, MD

  Kütahya Health Sciences University, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No parties were masked in this study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: October 3, 2025
• Study Start: June 20, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)