Inspiratory Muscle Training in Patients With Interstitial Lung Disease (IMT-ILD)

Effects of Inspiratory Muscle Training in Inspiratory Muscle Endurance, Breathlessness, Inspiratory Muscle Strength, Functional Capacity and Quality of Life in Patients With Interstitial Lung Disease

The aim of this study is to evaluate the effects of inspiratory muscle training program in inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis; Pulmonary Disease; Interstitial Lung Disease; Sarcoidosis; Interstitial Fibrosis; Pneumonia, Interstitial
• Intervention / Treatment: Other: Inspiratory muscle training

Detailed Description

Inspiratory Muscle Training has been described as an effective intervention and contribute to the improvement of inspiratory muscle function and breathlessness in patients with chronic lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. It is a quasi-experimental study. Patients with interstitial lung disease are recruited from interstitial disease ambulatory. In each session patients performs two times 30 breaths with a minute rest between them. The load is set according with 50% of actual PImax, the Borg score should be between 4 and 6, otherwise the load will decrease (if Borg more than 6) or increase (if Borg less than 4). New PImax is measured weekly and the new load is defined following the same protocol for 8 weeks. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150-260
      • Ambulatório Bias Fortes - Ambulatório de Doenças Intersticiais do Hospital das Clínicas da Universidade Federal de Minas Gerais.
    • Belo Horizonte, Minas Gerais, Brazil, 31270-901
      • Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical and radiological diagnosis of interstitial lung disease established by a pulmonologist;
• Absence of clinical exacerbations of the disease in the four weeks prior to the initial data collection;
• Present medical research council scale more than 2;
• Absence of a associated or self reported cardiac, orthopedic and psychiatric diseases,
• Not participating in pulmonary rehabilitation programs;
• Do not use supplemental oxygen therapy while resting.

Exclusion Criteria:

- Inability of the participant to understand or perform the procedures proposed during the evaluations and training program.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Inspiratory muscle training group; Group intervention: home-based interval inspiratory muscle training during 8 weeks, two sessions with two sets of 30 breaths with one minute rest between them. Load set is determinated weekly, aiming 50% of actual PImax and according to Borg Score.	Other: Inspiratory muscle training; Inspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inspiratory muscle endurance	Endurance time in seconds	At baseline and after 8 weeks of training
Change in Breathlessness	Medical Research Council (1-5)	At baseline and after 8 weeks of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inspiratory muscle strength	Maximal inspiratory pressure in cmH20	At baseline and after 8 weeks of training
Change in Functional capacity	Maximal distance in 6 minute walk test	At baseline and after 8 weeks of training
Change in Quality of life	King's Brief Interstitial Lung Disease Questionnaire. It is a 15 questions questionnaire. Total score can go from 0 - 100, 100 is the better quality of life.	At baseline and after 8 weeks of training

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Collaborators: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.; Conselho Nacional de Desenvolvimento Científico e Tecnológico

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 30, 2020
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: July 17, 2020
• First Submitted That Met QC Criteria: July 17, 2020
• First Posted (ACTUAL): July 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Inspiratory muscle training; Interstitial lung disease; Inspiratory muscle endurance; Breathless
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Respiration Disorders; Fibrosis; Lung Diseases; Respiratory Aspiration; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Lung Diseases, Interstitial; Sarcoidosis
• Other Study ID Numbers: UFMG_IMT-ILD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No