Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis

NCT03588260 | Completed

• 1 other identifier: IPF_MIP/MEP
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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.

  15 minutes

• 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.

  15 minutes

• 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.

  10 minutes

• 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.

  15 minutes

• The Quality of Life Questionaire

  Short Form 36

  20 minutes

Secondary Outcomes (2)

• The modified Medical Research Council (mMRC) scale

  3 minutes

• The fatigue severity scale

  15 minutes

Study Arms (2)

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

no intervention - cross-sectional observational only OTHER

no intervention - cross-sectional observational only

Healthy subjects; Idiopathic pulmonary fibrosis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Yedikule Chest Disease Hospital

Istanbul, Zeytinburnu, 34200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Motor Activity; Dyspnea

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Behavior; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 4, 2018
• First Posted: July 17, 2018
• Study Start: July 20, 2018
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: January 12, 2024

Record last verified: 2024-01

Locations

TU (1)