Comparison of Treadmill and Outdoor Walking in Patients With Fibromyalgia

February 22, 2026 updated by: Ayse Naz Kalem, Ankara Etlik City Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
6-minute walk test
Time Frame: First day of treatment, at the end of 4 week
First day of treatment, at the end of 4 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: First day of treatment, at the end of 4 week
First day of treatment, at the end of 4 week
Measurement of maximum inspiratory and expiratory pressure (MIP) and (MEP)
Time Frame: First day of treatment, at the end of 4 week
First day of treatment, at the end of 4 week
Beck Depression Scale
Time Frame: First day of treatment, at the end of 4 week
First day of treatment, at the end of 4 week
Fatigue Impact Scale
Time Frame: First day of treatment, at the end of 4 week
First day of treatment, at the end of 4 week
Short Form-36 (SF-36)
Time Frame: First day of treatment, at the end of 4 week
First day of treatment, at the end of 4 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Etlik City Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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