Effect of Respiratory Muscle Training in Interstitial Lung Patients

NCT05106556 | Unknown

• 1 other identifier: BezmialemVU-AYDIN-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the possible effects of inspiratory muscle training (IMT) on respiratory functions, functional capacity, balance and quality of life in patients with interstitial lung disease.

Conditions

Interstitial Lung Disease

Keywords

Interstitial lung disease; Interstitial pulmonary fibrosis; Sarcoidosis; Respiratory muscle training; Pulmonary Function; Functional Capacity; Physiotherapy; Balance; Quality of Life; 6 Minute Walk Test

Outcome Measures

Primary Outcomes (10)

• Respiratory Function Test / Forced Vital Capacity (FVC)

  Change from baseline Forced Vital Capacity (FVC) in respiratory function test at 8 weeks. FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Eight weeks

• Respiratory Function Test / Forced Expiratory Volume 1 second (FEV1)

  Change from baseline Forced Expiratory Volume 1 second (FEV1) in respiratory function test at 8 weeks. FEV1 will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Eight weeks

• Respiratory Function Test / Peak Expiratory Flow (PEF)

  Change from baseline Peak Expiratory Flow (PEF) in respiratory function test at 8 weeks. PEF will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Eight weeks

• Respiratory Function Test / Tiffeneau-Pinelli index (FEV1/FVC)

  Change from baseline Tiffeneau-Pinelli index (Forced Expiratory Volume 1 second (FEV1) / Forced Vital Capacity (FVC)) in respiratory function test at 8 weeks. FEV1 / FVC will be evaluated using spirometry, according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Eight weeks

• Respiratory Muscle Strength / Maximum Inspiratory Pressure (MIP)

  Change from baseline Maximum Inspiratory Pressure (MIP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Eight weeks

• Respiratory Muscle Strength / Maximum Expiratory Pressure (MEP)

  Change from baseline Maximum Expiratory Pressure (MEP) at 8 weeks. Respiratory muscle strength will be measured according to the portable, electronic intraoral pressure measuring device (MicroRPM, Micro Medical UK), American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.

  Eight weeks

• Functional Capacity

  Change from baseline distance covered in six-minute walk test at 8 weeks

  Eight weeks

• Balance / Postural Stability

  Change from baseline postural stability test score in Biodex Balance System at 8 weeks

  Eight weeks

• Balance / Limits of Stability

  Change from baseline limits of stability test score in Biodex Balance System SD at 8 weeks

  Eight weeks

• Balance / Sensory Integration and Balance Test Score

  Change from baseline sensory integration and balance test score in Biodex Balance System SD at 8 weeks

  Eight weeks

Secondary Outcomes (4)

• Peripheral Muscle Strength

  Eight weeks

• Pain Level

  Eight weeks

• Dyspnea

  Eight weeks

• Health-Related Quality of Life

  Eight weeks

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients in this group will receive conventional chest physiotherapy, two times a day, 5 days a week for 8 weeks. After the training given by the physiotherapist one exercise session will be supervised in a clinic per week, other sessions will be performed at home. Maximal inspiratory mouth pressure measurements will be measured once a week to eliminate the effect of learning, however the training intensity will remain at the lowest intensity of the device for 8 weeks and will not be increased.

Other: Conventional Chest Physiotherapy

Inspiratory Muscle Training (IMT) Group

EXPERIMENTAL

In addition to conventional chest physiotherapy programme, patients in this group will also receive inspiratory muscle training at %30 of the maximal inspiratory mouth pressure (MIP) value of at least five days a week, for 15 minutes twice days, for 8 weeks at home. One exercise session will be supervised in a clinic per week, other sessions will be performed at home. Maximal inspiratory mouth pressure measurements will be measured once a week. The training intensity will be increased weekly. At this rate it is 30% of the maximal inspiratory pressure value.

Other: Conventional Chest Physiotherapy; Other: Inspiratory Muscle Training

Interventions

Conventional Chest Physiotherapy OTHER

Programme will include diaphragmatic breathing exercise, pursed lip breathing exercise, thoracic expansion exercises, upper and lower extremity exercises, stretching the pectoral muscles, posture exercises, walking training and teaching respiratory control.

Control Group; Inspiratory Muscle Training (IMT) Group

Inspiratory Muscle Training OTHER

Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure with the threshold loading method.

Inspiratory Muscle Training (IMT) Group

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with interstitial lung disease (idiopathic pulmonary fibrosis, collagen vascular diseases, sarcoidosis, etc.),
• Being clinically stable,
• Not receiving supplemental oxygen therapy,
• No pulmonary infection in the last 6 weeks,
• Being ambulation.

You may not qualify if:

• Presence of obstructive pulmonary disease such as chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis
• Presence of a history of effort-induced syncope
• Presence of severe orthopedic or neurological disease
• Presence of unstable serious cardiac disease

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih/Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Pulmonary Fibrosis; Sarcoidosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Onur AYDIN, PhD (c)

  Bezmialem Vakif University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, PT, PhD (c)

Model Details: Group 1: Inspiratory Muscle Training (IMT) Group Group 2: Control Group

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 3, 2021
• Study Start: December 9, 2019
• Primary Completion: January 3, 2022
• Study Completion: January 31, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)