NCT07047391

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2025

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2025

Completed
Last Updated

August 7, 2025

Status Verified

May 1, 2025

Enrollment Period

1 month

First QC Date

June 20, 2025

Last Update Submit

August 6, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Modified Borg Scale

    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

    Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.

  • Visual Analog Scale

    Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.

  • Leicester Cough Survey

    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

    Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

June 20, 2025

First Posted

July 2, 2025

Study Start

May 16, 2025

Primary Completion

June 15, 2025

Study Completion

June 25, 2025

Last Updated

August 7, 2025

Record last verified: 2025-05

Locations