Inspiratory Muscle Training in Patients With Interstitial Lung Disease

Not Applicable

Completed

• Conditions: Interstitial Fibrosis; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis; Pneumonia, Interstitial; Pulmonary Disease; Sarcoidosis
• Interventions: Other: Inspiratory muscle training

• Registration Number: NCT04481074
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-07-17
• Study First Submitted QC: 2020-07-17
• Study First Posted: 2020-07-22
• Study Start: 2020-07-30
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inspiratory muscle training group	Inspiratory muscle training	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Inspiratory muscle strength	At baseline and after 8 weeks of training	Maximal inspiratory pressure in cmH20
Change in Functional capacity	At baseline and after 8 weeks of training	Maximal distance in 6 minute walk test
Change in Quality of life	At baseline and after 8 weeks of training	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.

Trial Locations

Locations (2)

Ambulatório Bias Fortes - Ambulatório de Doenças Intersticiais do Hospital das Clínicas da Universidade Federal de Minas Gerais.; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil