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Completed

NCT Number: NCT04481074

Inspiratory Muscle Training 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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspiratory Muscle Training

Other

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

Primary outcomes

  1. Change in Inspiratory muscle endurance

    Time frame: At baseline and after 8 weeks of training

    Endurance time in seconds

  2. Change in Breathlessness

    Time frame: At baseline and after 8 weeks of training

    Medical Research Council (1-5)

Secondary outcomes

  1. Change in Inspiratory muscle strength

    Time frame: At baseline and after 8 weeks of training

    Maximal inspiratory pressure in cmH20

  2. Change in Functional capacity

    Time frame: At baseline and after 8 weeks of training

    Maximal distance in 6 minute walk test

  3. Change in Quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Registry information

Official study 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

Acronym: IMT-ILD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 22, 2020
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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