Skip to main content
OpenTrials
Completed

NCT Number: NCT03588260

Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Idiopathic Pulmonary Fibrosis Behavior Dyspnea Lung Diseases Lung Diseases, Interstitial Motor Activity Pathological Conditions, Signs and Symptoms Pulmonary Fibrosis Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

no intervention - cross-sectional observational only

Other

no intervention - cross-sectional observational only

Primary outcomes

  1. Maximum inspiratory muscle pressure

    Time frame: 15 minutes

    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.

  2. Maximum expiratory muscle pressure

    Time frame: 15 minutes

    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.

  3. The distance covered in six-minute walk test

    Time frame: 10 minutes

    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.

  4. International Physical Activity Questionnaire

    Time frame: 15 minutes

    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.

  5. The Quality of Life Questionaire

    Time frame: 20 minutes

    Short Form 36

Secondary outcomes

  1. The modified Medical Research Council (mMRC) scale

    Time frame: 3 minutes

    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.

  2. The fatigue severity scale

    Time frame: 15 minutes

    • 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

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis: The Relationship With Exercise Capacity, Physical Activity Level, and Quality of Life

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 17, 2018
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.