Comparison of Treadmill and Outdoor Walking in Patients With Fibromyalgia

NCT07228897 | Recruiting

• 1 other identifier: AEŞH-EK-2025-182
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 6-minute walk test

  First day of treatment, at the end of 4 week

Secondary Outcomes (5)

• 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

Study Arms (2)

Open air walking

EXPERIMENTAL

Other: Walking exercises at open air place

treadmill

ACTIVE COMPARATOR

Other: Walking exercises with treadmill

Interventions

Walking exercises at open air place OTHER

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.

Open air walking

Walking exercises with treadmill OTHER

Patients will be enrolled in a treadmill exercise program in the cardiopulmonary exercise unit for 45 minutes, 3 days a week for 4 weeks.

treadmill

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Ayşe Naz Kalem Özgen, Specialist

CONTACT

03127970000; kalemnaz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PM&R Specialist

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 14, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: February 24, 2026

Record last verified: 2025-11

Locations

TU (1)