Prediction of Pulmonary Problems

Prediction of Pulmonary Problems in Individuals With Rheumatoid Arthritis-Associated Interstitial Lung Disease

The aim of this study was to examine the relationship between respiratory muscle strength and grip strength, muscle strength, oxygen saturation of peripheral muscles, dyspnea and respiration, cough, and health-related quality of life in individuals with Interstitial Lung Disease Associated with Rheumatoid Arthritis

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis (RA); Oxygen Saturation; Respiratory Muscle Strength

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with rheumatoid arthritis-associated interstitial lung disease follow-up at Pamukkale University Hospital

Description

Inclusion Criteria:

• ≥18 individuals diagnosed with RA by the same rheumatologist based on published results

Exclusion Criteria:

• Individuals with >10 pack-year smoking history
• Severe functional limitations
• Cardiopulmonary and/or neurological disease unrelated to RA

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of respiratory muscle strength	One of the most commonly used and noninvasive methods for assessing respiratory muscle strength is the measurement of MIP and MEP. Respiratory muscle strength was measured using a portable, electronic, oral pressure measuring device (Micro Medical MicroMPM, UK). These are intraoral pressures measured during maximal inspiration against a valve that closes the airway during maximum inspiration and expiration.	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Oxygen Saturation Measurement	Oxygen saturation measurement was performed with the MOXY (Fortiori Design LLC., Minnesota, USA) device. MOXY is a medical device with dimensions of 61x44x21 mm and a weight of 42 gr. It is an infrared measurement device called "near infrared spectroscopy" that measures oxygen saturation and total hemoglobin in muscle capillaries.	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Borg Scale	Although it is frequently used today to define the severity of exertional dyspnea, it is a scale that can also be used to evaluate the severity of resting dyspnea. It consists of ten items that define the severity of dyspnea according to their degrees. Scoring is done between 0 (not at all) and 10 (very severe).	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Modified Medical Research Council Dyspnea Scale	It is a scale based on various physical activities that cause dyspnea. It consists of five items. The patient rates respiratory distress between 0 (no shortness of breath) and 4 (shortness of breath during activities such as being homebound and dressing).	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Visual Analog Scale	It consists of a 100 mm long horizontal line with the words "none" and "very severe" written on one end. The patient marks the severity of the current respiratory distress on the line using these two degrees as criteria. Scoring is done by measuring the marked area with the help of a tape measure.	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Leicester Cough Survey	Measures the effect of cough on quality of life. It consists of 19 questions. It has psychological, social and physical sub-dimensions. The cut-off value of the scale is not defined; low scores indicate greater effect from cough, i.e. worse quality of life. The total severity score ranges from 3 to 21.	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
St. George's Respiratory Survey	It will be used to evaluate the health-related quality of life of the cases. SGRQ consists of three categories where the symptoms, activities and the effects of the disease on their daily lives are evaluated. The symptoms examined are cough, sputum, wheezing and shortness of breath. Physical functions, housework and hobbies are questioned to determine the activity status. These are activities limited by shortness of breath. The survey consisting of a total of 76 questions is completed in 20 minutes. There is an evaluation scale between zero and 100 points. Zero indicates perfect health status, 100 indicates the worst health status.	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Short Form-36 Quality of Life Survey	Short form-36 is a quality of life scale consisting of 36 items that can be filled by the patient and whose validity and reliability have been shown in studies in patients with musculoskeletal disorders. The Turkish version of SF-36 was used in our study. This scale includes 8 separate health-related headings as physical function (10 items), social function (2 items), physical role limitation (4 items), emotional role limitation (3 items), mental health (5 items), vitality (4 items), pain (2 items), general health (6 items).	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Health Assessment Questionnaire	Since it evaluates activities of daily living comprehensively and in all dimensions, HAQ was preferred in our study to assess the disability level. It includes 20 questions across 8 domains (dressing, arising, eating, walking, hygiene, reach, grip, and common activities). Each question is scored between 0 and 3 (without any difficulty = 0, with some difficulty = 1, with much difficulty = 2, unable to do = 3). The highest score of each subsection is summed up and divided by 8 to determine the total score between 0 and 3. A high score indicates a low functional level	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Disease Activity	Disease activity in rheumatoid arthritis will be assessed using the Clinical Disease Activity Index (CDAI). This index is calculated based on four main parameters: the number of painful joints, the number of swollen joints, the visual analog scale of global disease activity as assessed by the patient, and the visual analog scale of global disease activity as assessed by the physician. CDAI scores of 0-2.8 indicate remission, 2.9-10 indicate low disease activity, 11-22 indicate moderate activity, and 22-76 indicate high activity.	Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.

Collaborators and Investigators

• Sponsor: Zülal TATAR

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2025
• Primary Completion (Actual): June 15, 2025
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: June 20, 2025
• First Submitted That Met QC Criteria: June 30, 2025
• First Posted (Actual): July 2, 2025

Study Record Updates

• Last Update Posted (Actual): August 7, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: Pulmonary Problem

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No