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Trial record 39 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03588260
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
esra pehlivan, Istanbul Medipol University Hospital

Brief 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.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Other: no intervention - cross-sectional observational only

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.

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Study Type : Observational
Estimated Enrollment : 62 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis: The Relationship With Exercise Capacity, Physical Activity Level, and Quality of Life
Actual Study Start Date : July 20, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019


Group/Cohort Intervention/treatment
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
no intervention - cross-sectional observational only

Healthy subjects
The healthy adults without additional disease
Other: no intervention - cross-sectional observational only
no intervention - cross-sectional observational only




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588260


Contacts
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Contact: Esra Pehlivan, PhD +905058527913 fztesrakambur@yahoo.com
Contact: Arif Balcı arifbalci2000@yahoo.com

Locations
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Turkey
Yedikule Chest Disease Hospital Recruiting
Istanbul, Zeytinburnu, Turkey, 34200
Contact: Esra Pehlivan, PhD    +905058527913    fztesrakambur@yahoo.com   
Contact    +902124090200      
Sponsors and Collaborators
Istanbul Medipol University Hospital

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Responsible Party: esra pehlivan, Principal investigator, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier: NCT03588260     History of Changes
Other Study ID Numbers: IPF_MIP/MEP
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by esra pehlivan, Istanbul Medipol University Hospital:
idiopathic pulmonary fibrosis
respiratory muscle strength
physical activity
quality of life
dyspnea
fatigue severity
exercise capacity

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial