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Respiratory Muscle StrengthNCT07047391

Prediction of Pulmonary Problems

An observational study of Respiratory Muscle Strength and Oxygen Saturation, run by Zülal TATAR at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
How many people
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 May 2025to 25 Jun 2025
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Pamukkale University

    Denizli

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Medical subject headings
Arthritis, Rheumatoid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (8)
  1. 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).

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

  2. 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).

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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).

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

  7. 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

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

  8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study start16 May 2025
  3. Primary completion15 Jun 2025
  4. Study completion25 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
24 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07047391
Sponsor's protocol ID
Pulmonary Problem
Status last verified
May 2025
First submitted
20 Jun 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Respiratory Muscle Strength and Oxygen Saturation, run by Zülal TATAR at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of respiratory muscle strength (time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.

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