ClinicalTrials.gg
CompletedNCT07047391Updated Aug 7, 2025

Prediction of Pulmonary Problems

An observational study in Respiratory Muscle Strength, Oxygen Saturation and Rheumatoid Arthritis (RA), sponsored by Zülal TATAR. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-07.

Sponsored by Zülal TATAR · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
24
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 126 studies in Arthritis, Rheumatoid with a site in Turkey — 14 open to participants now, 19 under way, 2 of them phase 3. Arthritis, Rheumatoid · Turkey.

Enrollment
48th of 49
24 · median 100
Started
2025
with 16 others
Observational
49 of 126
9 open now
Registered
103rd of 126
by date

Among the 126 studies in Arthritis, Rheumatoid with a site in Turkey, this one is the 48th largest by enrollment of the 49 observational ones that give a count, is one of 17 that started in 2025, is one of 49 observational ones, and was the 103rd registered.

Arthritis, Rheumatoid

3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.

Browse Arthritis, Rheumatoid studies →

Open to participants now

14 of the 126 studies in Arthritis, Rheumatoid with a site in Turkey are open now. Recruiting first, the newest first:

9 more — sign in →

All 14 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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

03

Conditions studied

  • Respiratory Muscle Strength
  • Oxygen Saturation
  • Rheumatoid Arthritis (RA)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Individuals with >10 pack-year smoking history
  • Severe functional limitations
  • Cardiopulmonary and/or neurological disease unrelated to RA
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
24 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

Secondary outcomes

  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).

    Time frame: 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).

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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

    Time frame: 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.

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

07

Study locations

1 site
  • Pamukkale University
    Denizli, Turkey (Türkiye)
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2025 to primary completion in Jun 2025, 0 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 20, 2025
First posted
Jul 2, 2025
StartActual
May 16, 2025
Primary completionActual
Jun 15, 2025
CompletionActual
Jun 25, 2025
Last update
Aug 7, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07047391
Lead sponsor
Zülal TATAR
Responsible party
Zülal TATAR (Researcher, Pamukkale University) — Sponsor-investigator
First posted
Jul 2, 2025
Start date
May 16, 2025
Primary completion
Jun 15, 2025
Completion
Jun 25, 2025
Last update
Aug 7, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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