FibromyalgiaNCT07228897
Comparison of Treadmill and Outdoor Walking in Patients With Fibromyalgia
A study testing Walking exercises with treadmill and Walking exercises at open air place in people with Fibromyalgia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Walking exercises with treadmill and Walking exercises at open air place
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara, Yenimahalle, 06170
Ayşe Naz Kalem Özgen, Specialist, 0312 797 00 00, kalemnaz@gmail.com
About this study
Official 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
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
- Being tested
- Walking exercises with treadmill, Walking exercises at open air place
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking exercises with treadmillOther
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 placeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Open air walking | Experimental | Not described Receives: Other: Walking exercises at open air place |
| treadmill | Active comparator | Not described Receives: Other: Walking exercises with treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
Measured: First day of treatment, at the end of 4 week
Secondary outcomes (5)
Fibromyalgia Impact Questionnaire (FIQ)
Measured: First day of treatment, at the end of 4 week
Measurement of maximum inspiratory and expiratory pressure (MIP) and (MEP)
Measured: First day of treatment, at the end of 4 week
Beck Depression Scale
Measured: First day of treatment, at the end of 4 week
Fatigue Impact Scale
Measured: First day of treatment, at the end of 4 week
Short Form-36 (SF-36)
Measured: First day of treatment, at the end of 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start5 Dec 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ayse Naz Kalem, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228897
- Sponsor's protocol ID
- AEŞH-EK-2025-182
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07228897
- Acronym / sponsor ID
- AEŞH-EK-2025-182
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open air walking | Experimental | Other: Walking exercises at open air place |
| treadmill | Active comparator | Other: Walking exercises with treadmill |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking exercises with treadmillPatients will be enrolled in a treadmill exercise program in the cardiopulmonary exercise unit for 45 minutes, 3 days a week for 4 weeks. | Other | treadmill |
| Walking exercises at open air placePatients 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. | Other | Open air walking |
Primary outcome
6-minute walk test
Time frame: First day of treatment, at the end of 4 week
5 secondary outcomes
Fibromyalgia Impact Questionnaire (FIQ)
Time frame: 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
Beck Depression Scale
Time frame: 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
Short Form-36 (SF-36)
Time frame: First day of treatment, at the end of 4 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking exercises with treadmill and Walking exercises at open air place in people with Fibromyalgia, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Naz Kalem Özgen, Specialist (03127970000, kalemnaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk test (time frame: First day of treatment, at the end of 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.