Respiratory Muscle Strength in Patients With Idiopathic Pulmonary Fibrosis

Sponsor

Istanbul Medipol University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03588260

Collaborator

(none)

Enrollment

Location

50.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Jul 20, 2018

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

Arm	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

Arm

Intervention/Treatment

Idiopathic pulmonary fibrosis

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

Outcome Measures

Primary Outcome Measures

Maximum inspiratory muscle pressure [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.
Maximum expiratory muscle pressure [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.
The distance covered in six-minute walk test [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.
International Physical Activity Questionnaire [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.
The Quality of Life Questionaire [20 minutes]
Short Form 36

Secondary Outcome Measures

The modified Medical Research Council (mMRC) scale [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.
The fatigue severity scale [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