Comparison of Treadmill and Outdoor Walking in Patients With Fibromyalgia

Evaluation of the Effect of Open-Air Walking Supported by Treadmill and Mobile Application on Cardiopulmonary Function and Quality of Life in Patients With Fibromyalgia Syndrome

While walking exercises performed outdoors are important within the scope of aerobic exercise, the continuity of outdoor walking exercises can be negatively affected by different weather conditions. Walking exercises performed indoors on a treadmill are a good option for patients in terms of increasing exercise continuity and patient compliance. Walking outdoors supported by a treadmill and mobile application may increase aerobic capacity and quality of life in patients with fibromyalgia syndrome, as well as reduce kinesiophobia.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Walking exercises at open air place; Other: Walking exercises with treadmill

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ayşe Naz Kalem Özgen, Specialist; Phone Number: 03127970000; Email: kalemnaz@gmail.com

Study Locations

• Turkey (Türkiye)
  • Yenimahalle
    • Ankara, Yenimahalle, Turkey (Türkiye), 06170
      • Recruiting
      • Etlik City Hospital
      • Contact: Ayşe Naz Kalem Özgen, Specialist; Phone Number: 0312 797 00 00; Email: kalemnaz@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be between the ages of 25 and 55
2. Be female
3. Have not engaged in regular physical activity for the past 3 months
4. Have been using the same medical treatment for at least 1 month prior to the study (amitriptyline, duloxetine/milnacipran, pregabalin, cyclobenzaprine)
5. Volunteering to participate in the study
6. The patient's cognitive status being suitable for using a mobile application
7. The patient agreeing to the 'Personal Data Protection Law Information Text' in order to use the mobile application

Exclusion Criteria:

1. History of cardiac or pulmonary disease
2. Changes in medical treatment during the study period
3. Use of different injection methods (ozone therapy, neural therapy, acupuncture, etc.) at least 3 months prior to the study or during the study period
4. History of rheumatological disease
5. Pregnancy or breastfeeding
6. History of malignancy
7. Presence of psychiatric or neurological disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open air walking	Other: Walking exercises at open air place; Patients will walk briskly outdoors for 45 minutes, 3 days a week for 4 weeks. Patients will receive notifications via a mobile app reminding them of their daily walk, and they will be asked to log their walks in the mobile app.
Active Comparator: treadmill	Other: Walking exercises with treadmill; Patients will be enrolled in a treadmill exercise program in the cardiopulmonary exercise unit for 45 minutes, 3 days a week for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
6-minute walk test	First day of treatment, at the end of 4 week

Secondary Outcome Measures

Outcome Measure	Time Frame
Fibromyalgia Impact Questionnaire (FIQ)	First day of treatment, at the end of 4 week
Measurement of maximum inspiratory and expiratory pressure (MIP) and (MEP)	First day of treatment, at the end of 4 week
Beck Depression Scale	First day of treatment, at the end of 4 week
Fatigue Impact Scale	First day of treatment, at the end of 4 week
Short Form-36 (SF-36)	First day of treatment, at the end of 4 week

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 13, 2025
• First Submitted That Met QC Criteria: November 13, 2025
• First Posted (Actual): November 14, 2025

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia
• Other Study ID Numbers: AEŞH-EK-2025-182

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No