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CompletedNCT03588260Updated Jan 12, 2024

Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis

An observational study in Idiopathic Pulmonary Fibrosis, sponsored by Istanbul Medipol University Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-12.

Sponsored by Istanbul Medipol University Hospital · Observational

Study type
Observational
Model
Case-crossover
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Respiratory muscle strength, dyspnea perception, physical activity and quality of life measurements will be performed and groups will be compared in two groups consisting of patients with idiopathic pulmonary fibrosis referred to pulmonary rehabilitation clinic and healthy volunteers in similar age range.

Read the detailed description

The patients who have agreed to participate in the study from patients diagnosed with idiopathic pulmonary fibrosis referred to the center of pulmonary rehabilitation from the interstitial lung disease polyclinic will be included in the study. In addition, a healthy adult control group will be established from similar age groups. The two groups will be compared in terms of outcome measures.The study outcome measurements are maximum inspiratory/expiratory muscle strength , international physical activity questionaire, modified Medical Research Council dyspnea scale, Short form 36 quality of lide questionaire, fatigue severity scale, six minute walking test.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • idiopathic pulmonary fibrosis
  • respiratory muscle strength
  • physical activity
  • quality of life
  • dyspnea
  • fatigue severity
  • exercise capacity
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 60 is below the median of 130 across 229 observational studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The patients who have agreed to participate in the study from patients diagnosed with idiopathic pulmonary fibrosis referred to the center of pulmonary rehabilitation from the interstitial lung disease polyclinic will be included in the study. In addition, a healthy adult control group will be established from similar age groups. The two groups will be compared in terms of outcome measures.

Inclusion criteria

  • Between the ages of 18-70
  • Patients signing informed consent form
  • Patients diagnosed with idiopathic pulmonary fibrosis.

Exclusion criteria

Exclusion Criteria:

  • Patients who use steroids for less than 1 year
  • The patient does not want to participate in the study
05

Study design

Observational model
Case-crossover
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Idiopathic pulmonary fibrosis

    The patients who have agreed to participate in the study from patients diagnosed with idiopathic pulmonary fibrosis referred to the center of pulmonary rehabilitation from the interstitial lung disease polyclinic.

    Other: no intervention - cross-sectional observational only

  • Healthy subjects

    The healthy adults without additional disease

    Other: no intervention - cross-sectional observational only

Interventions

  • Otherno intervention - cross-sectional observational only

    no intervention - cross-sectional observational only

06

What researchers measure

Primary outcomes

  1. Maximum inspiratory muscle pressure

    The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.

    Time frame: 15 minutes

  2. Maximum expiratory muscle pressure

    The mouth pressure measurement was performed with the Micro-RPM® instrument from SensorMEDIC. Patient placed a rubber mouthpiece with flanges, on the device, sealed their lips firmly around the mouthpiece, exhaled/inhaled slowly and completely, and then tried to breath in as hard as possible. The patient was allowed to rest for about a minute and the maneuver was repeated five times. Verbal or visual feedback was provided after each maneuver. The aim is that the variability between measurements is less than 10 cm H2O. The maximum value was obtained.

    Time frame: 15 minutes

  3. The distance covered in six-minute walk test

    The test was conducted in a 30-meter corridor in line with American Thoracic Society (ATS) guidelines. Patients were told that they should walk as fast as they can walk. Before and after the test, oxygen saturation, heart rate, Borg fatigue rating, and walking distance were recorded.

    Time frame: 10 minutes

  4. International Physical Activity Questionnaire

    The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.

    Time frame: 15 minutes

  5. The Quality of Life Questionaire

    Short Form 36

    Time frame: 20 minutes

Secondary outcomes

  1. The modified Medical Research Council (mMRC) scale

    Dyspnea perceptions during daily life activities will assess according to the modified Medical Research Council (mMRC) scale. The mMRC Dyspnea Scale is best used to establish baseline functional impairment due to dyspnea attributable to respiratory disease; tracking the mMRC over time or with therapeutic interventions is of less certain clinical utility.The severity of dyspnea is rated on a scale of 0 to 4. "0" means no dyspnea perception, "4" means severe dyspnea perception.

    Time frame: 3 minutes

  2. The fatigue severity scale

    * A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity. * The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree * The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity * Another way of scoring: mean of all the scores with minimum score being 1 and maximum score being 7 * Self-report scale

    Time frame: 15 minutes

07

Study locations

1 site
  • Yedikule Chest Disease Hospital
    Istanbul, Zeytinburnu 34200, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03588260
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
esra pehlivan (Principal investigator, Istanbul Medipol University Hospital) — Principal investigator
First posted
Jul 17, 2018
Start date
Jul 20, 2018
Primary completion
Dec 30, 2023
Completion
Dec 30, 2023
Last update
Jan 12, 2024

Oversight

Data monitoring committee
No
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 Jan 2024. You cannot join it, but the record below documents what was studied.

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