Rheumatoid ArthritisNCT06769386
Investigation of Muscle Oxygenation in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate respiratory muscle strength, respiratory muscle endurance, muscle oxygenation, upper extremity and lower extremity exercise capacity in rheumatoid arthritis patients compared with healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Jan 2025to 25 Jan 2027
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Rheumatoid arthritis patients (diagnosed according to American College of Rheumatology/European Alliance of Associations for Rheumatology ACR/EULAR 2022 diagnostic criteria) aged between 18-65 years, with a Disease Activity Score (DAS)-28 score below 2.6 in disease remission and followed up at the Rheumatology Polyclinic of the Department of Physical Medicine and Rehabilitation at Kirsehir Ahi Evran University will be included in the study. As a control group, healthy individuals between the ages of 18-65, who are similar to the patients in terms of age and gender, without any disease, will be included in the study.
Who may be able to join
- Patients diagnosed with rheumatoid arthritis,
- The ages of 18-65 years,
- Volunteer to participate in the study will be included in the study.
- The ages of 18-65 years,
- Volunteer to participate in the study will be included in the study.
Who cannot join
- Serious cardiopulmonary, neurological, neuromuscular, orthopedic and other systemic diseases or other diseases affecting physical functions,
- Participated in a planned exercise program in the last three months,
- Cognitive impairment that will cause difficulty in understanding and following exercise test instructions,
- Contraindications to exercise testing or exercise training according to the American Sports Medicine Association will not be included in the study.
- Control Group
- Diagnosed chronic or systemic disease,
Show all 10Show fewer
- Regular exercise (physical activity) 3 days a week, 150 minutes/week of moderate intensity
- Smoking 10 packs x years or more,
- Pneumonia or any acute infection,
- Healthy individuals with any psychiatric disorder will not be included in the study.
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
Kırşehir Ahi Evran University, Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit
Kırşehir, Merkez, 40100
Başak KAVALCI KOL, PhD, +903862802317, basak.kavalci@ahievran.edu.tr
About this study
Official title: Investigation of Respiratory Muscle Strength, Respiratory Muscle Endurance and Muscle Oxygenation in Patients With Rheumatoid Arthritis
The aim of this study is to investigate respiratory muscle strength, respiratory muscle endurance, muscle oxygenation, upper extremity and lower extremity exercise capacity in rheumatoid arthritis patients compared with healthy individuals.
Read the detailed description
Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease of unknown etiology with symmetric erosive synovitis and multisystem involvement. The disease causes significant long-term morbidity, reduced functional capacity, and increased mortality rates. Patients with rheumatoid arthritis avoid physical activity due to pain and fatigue. Despite the advances in pharmacological treatments in recent years, functional losses due to rheumatic diseases the resulting deterioration in quality of life, and loss of work continue. Physical inactivity is known to have detrimental effects on the cardiovascular and pulmonary systems by reducing muscle strength and aerobic capacity. The physiological reasons underlying skeletal muscle oxygenation that may cause muscle dysfunction in rheumatoid arthritis have not been investigated. In these patients, decreased arterial oxygen may reduce exercise capacity and cause muscle deoxygenation.
In rheumatoid arthritis patients, decreases in respiratory muscle strength, lung volumes, oxygen consumption, and six minute walk test distance cause cardiopulmonary deconditioning. Decreased exercise capacity increases the risk of cardiovascular disease and causes mortality in patients with RA.
This study aimed to, the effects of respiratory muscle strength, respiratory muscle endurance, upper and lower extremity muscle oxygenation, and upper and lower extremity exercise capacity in patients with stable disease activity.
- Conditions
- Rheumatoid Arthritis
- Keywords
- exercise capacity, muscle oxygenation, rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis Group | Rheumatoid arthritis patients who are followed up in the Rheumatology Outpatient Clinic of the Department of Physical Medicine and Rehabilitation (diagnosed according to American College of Rheumatology/European Alliance of Associations for Rheumatology ACR/EULAR 2022 diagnostic criteria), aged between 18-65 years, and have a Disease Activity Score (DAS) -28 score below 2.6 in disease remission will be included. | |
| Control Group | As a control group, healthy individuals between the ages of 18-65, who are similar to the patients in terms of age and gender, without any disease, will be included in the study. Healthy individuals in the control group will be selected from volunteer colleagues, school friends, family and residential areas of the researchers to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of respiratory muscle strength
An electronic mouth pressure measuring device that complies with American Thoracic Society and European Respiratory Society criteria will be used to assess respiratory muscle strength.
Measured: First day
Evaluation of respiratory muscle endurance
The incremental threshold workload test will be used to assess respiratory muscle endurance.The PowerBreathe Wellness® (HaB International Ltd. Southam, United Kingdom) inspiratory muscle training device will be used in the incremental threshold load test.
Measured: First day
Evaluation of Deltoid and Quadriceps Femoris Muscle Oxygenation
Muscle oxygen level of quadriceps femoris and deltoid muscles will be measured using Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA) before, during and after the six-minute walk test and six-minute peg-board and ring test.
Measured: First and second day
Evaluation of Deltoid and Quadriceps Femoris Muscle Total Hemoglobin Level
Total hemoglobin level of quadriceps femoris and deltoid muscles will be measured using Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA) before, during and after the six-minute walk test and six-minute peg-board and ring test.
Measured: First and second day
Secondary outcomes (2)
Evaluation of submaximal exercise capacity
The six-minute walk test will be performed according to American Thoracic Society criteria to evaluate functional exercise capacity.
Measured: First day and second day
Evaluation of upper extremity capacity
The six-minute peg board and ring test will be used to assess upper extremity exercise capacity.
Measured: First day and second day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start25 Jan 2025
- Primary completion25 Jan 2026 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran UniversitesiThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Başak KAVALCI KOL, Kirsehir Ahi Evran Universitesi
- Investigators
- Başak KAVALCI KOL, PhD, Principal investigator, Kirsehir Ahi Evran UniversitesiMerve FIRAT, PhD, Study chair, Kirsehir Ahi Evran UniversitesiFigen TUNCAY, Prof. Dr., Study chair, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06769386
- Sponsor's protocol ID
- AhiEvranU526
- Status last verified
- Feb 2025
- First submitted
- 7 Jan 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be stored in a locked cabinet.
Publications
Wickerson L, Mathur S, Brooks D, Bonetti LV, Singer LG, Granton J, Reid WD. Skeletal muscle oxygenation and regional blood volume during incremental limb loading in interstitial lung disease. ERJ Open Res. 2020 Jan 27;6(1):00083-2019. doi: 10.1183/23120541.00083-2019. eCollection 2020 Jan.
PubMed 32010722Cimen B, Deviren SD, Yorgancloglu ZR. Pulmonary function tests, aerobic capacity, respiratory muscle strength and endurance of patients with rheumatoid arthritis. Clin Rheumatol. 2001;20(3):168-73. doi: 10.1007/s100670170058.
PubMed 11434466
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Respiratory Muscle Strength, Respiratory Muscle Endurance and Muscle Oxygenation in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06769386
- Acronym / sponsor ID
- AhiEvranU526
- Conditions
- Rheumatoid Arthritis
- Keywords
- exercise capacity, muscle oxygenation, rheumatoid arthritis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 25 Jan 2026 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 10 Jan 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.
The aim of this study is to investigate respiratory muscle strength, respiratory muscle endurance, muscle oxygenation, upper extremity and lower extremity exercise capacity in rheumatoid arthritis patients compared with healthy individuals.
Detailed description
Rheumatoid arthritis (RA) is a chronic progressive autoimmune disease of unknown etiology with symmetric erosive synovitis and multisystem involvement. The disease causes significant long-term morbidity, reduced functional capacity, and increased mortality rates. Patients with rheumatoid arthritis avoid physical activity due to pain and fatigue. Despite the advances in pharmacological treatments in recent years, functional losses due to rheumatic diseases the resulting deterioration in quality of life, and loss of work continue. Physical inactivity is known to have detrimental effects on the cardiovascular and pulmonary systems by reducing muscle strength and aerobic capacity. The physiological reasons underlying skeletal muscle oxygenation that may cause muscle dysfunction in rheumatoid arthritis have not been investigated. In these patients, decreased arterial oxygen may reduce exercise capacity and cause muscle deoxygenation.
In rheumatoid arthritis patients, decreases in respiratory muscle strength, lung volumes, oxygen consumption, and six minute walk test distance cause cardiopulmonary deconditioning. Decreased exercise capacity increases the risk of cardiovascular disease and causes mortality in patients with RA.
This study aimed to, the effects of respiratory muscle strength, respiratory muscle endurance, upper and lower extremity muscle oxygenation, and upper and lower extremity exercise capacity in patients with stable disease activity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis Group | – | –Rheumatoid arthritis patients who are followed up in the Rheumatology Outpatient Clinic of the Department of Physical Medicine and Rehabilitation (diagnosed according to American College of Rheumatology/European Alliance of Associations for Rheumatology ACR/EULAR 2022 diagnostic criteria), aged between 18-65 years, and have a Disease Activity Score (DAS) -28 score below 2.6 in disease remission will be included. |
| Control Group | – | –As a control group, healthy individuals between the ages of 18-65, who are similar to the patients in terms of age and gender, without any disease, will be included in the study. Healthy individuals in the control group will be selected from volunteer colleagues, school friends, family and residential areas of the researchers to participate in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients (diagnosed according to American College of Rheumatology/European Alliance of Associations for Rheumatology ACR/EULAR 2022 diagnostic criteria) aged between 18-65 years, with a Disease Activity Score (DAS)-28 score below 2.6 in disease remission and followed up at the Rheumatology Polyclinic of the Department of Physical Medicine and Rehabilitation at Kirsehir Ahi Evran University will be included in the study. As a control group, healthy individuals between the ages of 18-65, who are similar to the patients in terms of age and gender, without any disease, will be included in the study.
Key inclusion criteria (5 listed)
- Patients diagnosed with rheumatoid arthritis,
- The ages of 18-65 years,
- Volunteer to participate in the study will be included in the study.
- The ages of 18-65 years,
- Volunteer to participate in the study will be included in the study.
Key exclusion criteria (10 listed)
- Serious cardiopulmonary, neurological, neuromuscular, orthopedic and other systemic diseases or other diseases affecting physical functions,
- Participated in a planned exercise program in the last three months,
- Cognitive impairment that will cause difficulty in understanding and following exercise test instructions,
- Contraindications to exercise testing or exercise training according to the American Sports Medicine Association will not be included in the study.
- Control Group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of respiratory muscle strength
Time frame: First day
An electronic mouth pressure measuring device that complies with American Thoracic Society and European Respiratory Society criteria will be used to assess respiratory muscle strength.
Evaluation of respiratory muscle endurance
Time frame: First day
The incremental threshold workload test will be used to assess respiratory muscle endurance.The PowerBreathe Wellness® (HaB International Ltd. Southam, United Kingdom) inspiratory muscle training device will be used in the incremental threshold load test.
Evaluation of Deltoid and Quadriceps Femoris Muscle Oxygenation
Time frame: First and second day
Muscle oxygen level of quadriceps femoris and deltoid muscles will be measured using Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA) before, during and after the six-minute walk test and six-minute peg-board and ring test.
Evaluation of Deltoid and Quadriceps Femoris Muscle Total Hemoglobin Level
Time frame: First and second day
Total hemoglobin level of quadriceps femoris and deltoid muscles will be measured using Moxy® monitor (Moxy, Fortiori Design LLC, Minnesota, USA) before, during and after the six-minute walk test and six-minute peg-board and ring test.
2 secondary outcomes
Evaluation of submaximal exercise capacity
Time frame: First day and second day
Evaluation of upper extremity capacity
Time frame: First day and second day
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 11 Feb 2025.
- Background: PubMed 32010722Wickerson L, Mathur S, Brooks D, Bonetti LV, Singer LG, Granton J, Reid WD. Skeletal muscle oxygenation and regional blood volume during incremental limb loading in interstitial lung disease. ERJ Open Res. 2020 Jan 27;6(1):00083-2019. doi: 10.1183/23120541.00083-2019. eCollection 2020 Jan.
- Background: PubMed 11434466Cimen B, Deviren SD, Yorgancloglu ZR. Pulmonary function tests, aerobic capacity, respiratory muscle strength and endurance of patients with rheumatoid arthritis. Clin Rheumatol. 2001;20(3):168-73. doi: 10.1007/s100670170058.
- Individual participant dataSharing planned: No. All data will be stored in a locked cabinet.
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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.
Başak KAVALCI KOL, PhD principal investigator
Kirsehir Ahi Evran Universitesi
Merve FIRAT, PhD study chair
Kirsehir Ahi Evran Universitesi
Figen TUNCAY, Prof. Dr. study chair
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Kirsehir Ahi Evran Universitesi 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 5 inclusion and 10 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 11 Feb 2025. 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 Başak KAVALCI KOL, PhD (+903862802317, basak.kavalci@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of respiratory muscle strength (time frame: First day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06769386, which also lists 2 linked publications.
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 11 Feb 2025.