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).
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
- Conditions the study is for
- Respiratory Muscle Strength, Oxygen Saturation, Rheumatoid Arthritis (RA)
- 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.
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.
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.
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)
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.
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.
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.
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.
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.
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.
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.
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.
- First posted2 Jul 2025
- Study start16 May 2025
- Primary completion15 Jun 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Muscle StrengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Zülal TATAR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zülal TATAR, Pamukkale University
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Pulmonary Problems in Individuals With Rheumatoid Arthritis-Associated Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07047391
- Acronym / sponsor ID
- Pulmonary Problem
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zülal TATARUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis-associated interstitial lung disease follow-up at Pamukkale University Hospital
Key inclusion criteria (1 listed)
- ≥18 individuals diagnosed with RA by the same rheumatologist based on published results
Key exclusion criteria (3 listed)
- Individuals with >10 pack-year smoking history
- Severe functional limitations
- Cardiopulmonary and/or neurological disease unrelated to RA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Oxygen Saturation Measurement
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
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.
8 secondary outcomes
Modified Borg Scale
Time frame: 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
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Visual Analog Scale
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Leicester Cough Survey
Time frame: 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
Time frame: 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
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Health Assessment Questionnaire
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Disease Activity
Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 1 months, which is the study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.