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NCT Number: NCT07228897

Comparison of Treadmill and Outdoor Walking in Patients With Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Etlik City Hospital

Ankara, Yenimahalle, 06170, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayşe Naz Kalem Özgen, Specialist

CONTACT

[email protected]

0312 797 00 00

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 6-minute walk test

    Time frame: First day of treatment, at the end of 4 week

Secondary outcomes

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Time frame: First day of treatment, at the end of 4 week

  2. Measurement of maximum inspiratory and expiratory pressure (MIP) and (MEP)

    Time frame: First day of treatment, at the end of 4 week

  3. Beck Depression Scale

    Time frame: First day of treatment, at the end of 4 week

  4. Fatigue Impact Scale

    Time frame: First day of treatment, at the end of 4 week

  5. Short Form-36 (SF-36)

    Time frame: First day of treatment, at the end of 4 week

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Naz Kalem Özgen, Specialist

CONTACT

[email protected]

03127970000

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2025
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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