Investigation of Muscle Oxygenation in Patients With Rheumatoid Arthritis

Recruiting

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT06769386
• Lead Sponsor: Kirsehir Ahi Evran Universitesi

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.

Study Timeline

• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-10
• Study Start: 2025-01-25
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-01-25
• Study Completion: 2027-01-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

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.

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

Inclusion Criteria:

• The ages of 18-65 years,
• Volunteer to participate in the study will be included in the study.

Exclusion Criteria:

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of respiratory muscle strength	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	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 Total Hemoglobin Level	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.
Evaluation of Deltoid and Quadriceps Femoris Muscle Oxygenation	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of submaximal exercise capacity	First day and second day	The six-minute walk test will be performed according to American Thoracic Society criteria to evaluate functional exercise capacity.
Evaluation of upper extremity capacity	First day and second day	The six-minute peg board and ring test will be used to assess upper extremity exercise capacity.

Trial Locations

Locations (1)

Kırşehir Ahi Evran University, Physical Therapy and Rehabilitation Center, Cardiopulmonary Unit; 🇹🇷 Kırşehir, Merkez, Turkey