Inspiratory Muscle Training in Patients With Interstitial Lung Disease

Idiopathic Pulmonary Fibrosis Clinical Trial

— IMT-ILD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481074
• Other study ID #: UFMG_IMT-ILD
• Status: Completed
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: February 2022
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Interstitial Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pneumonia, Interstitial
• Pulmonary Disease
• Pulmonary Fibrosis
• Respiratory Aspiration
• Sarcoidosis

Intervention

Other:
• Inspiratory muscle training
Inspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®).

Locations

Country	Name	City	State
Brazil	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

Sponsors (3)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Inspiratory muscle endurance	Endurance time in seconds	At baseline and after 8 weeks of training
Primary	Change in Breathlessness	Medical Research Council (1-5)	At baseline and after 8 weeks of training
Secondary	Change in Inspiratory muscle strength	Maximal inspiratory pressure in cmH20	At baseline and after 8 weeks of training
Secondary	Change in Functional capacity	Maximal distance in 6 minute walk test	At baseline and after 8 weeks of training
Secondary	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