Investigation of Muscle Oxygenation in Patients With Rheumatoid Arthritis

NCT06769386 | Recruiting

• 1 other identifier: AhiEvranU526
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

exercise capacity; muscle oxygenation; rheumatoid arthritis

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  First and second day

Secondary Outcomes (2)

• Evaluation of submaximal exercise capacity

  First day and second day

• Evaluation of upper extremity capacity

  First day and second day

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients diagnosed with rheumatoid arthritis,
• The ages of 18-65 years,
• Volunteer to participate in the study will be included in the study.

You may not qualify if:

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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

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

Kırşehir, Merkez, 40100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 32010722 BACKGROUND

• 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.

  PMID: 11434466 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Başak KAVALCI KOL, PhD

  Kirsehir Ahi Evran Universitesi

  PRINCIPAL INVESTIGATOR

• Merve FIRAT, PhD

  Kirsehir Ahi Evran Universitesi

  STUDY CHAIR

• Figen TUNCAY, Prof. Dr.

  Kirsehir Ahi Evran Universitesi

  STUDY CHAIR

Central Study Contacts

Başak KAVALCI KOL, PhD

CONTACT

+903862802317; basak.kavalci@ahievran.edu.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 10, 2025
• Study Start: January 25, 2025
• Primary Completion: January 25, 2026
• Study Completion (Estimated): January 25, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)