Investigation of Muscle Oxygenation in Patients With Rheumatoid Arthritis

NCT ID: NCT06769386

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 68 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-25
• Study Completion Date: 2027-01-25

Brief 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.

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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,
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kirsehir Ahi Evran Universitesi

OTHER

Sponsor Role: lead

Responsible Party

Başak KAVALCI KOL

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Başak KAVALCI KOL, PhD

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran Universitesi

Merve FIRAT, PhD

Role: STUDY_CHAIR

Kirsehir Ahi Evran Universitesi

Figen TUNCAY, Prof. Dr.

Role: STUDY_CHAIR

Kirsehir Ahi Evran Universitesi

Locations

Kırşehir Ahi Evran University, Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit

Kırşehir, Merkez, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Başak KAVALCI KOL, PhD

Role: CONTACT

basak.kavalci@ahievran.edu.tr

+903862802317

Facility Contacts

Başak KAVALCI KOL, PhD

Role: primary

basak.kavalci@ahievran.edu.tr

+903862802317

References

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.

Reference Type: BACKGROUND

PMID: 32010722 (View on PubMed)

Cimen 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.

Reference Type: BACKGROUND

PMID: 11434466 (View on PubMed)

Other Identifiers

AhiEvranU526

Identifier Type: -

Identifier Source: org_study_id