CClinicalTrials.gg
CompletedNCT04481074IMT-ILDUpdated Feb 3, 2022

Inspiratory Muscle Training in Patients With Interstitial Lung Disease

An interventional study of Inspiratory muscle training in Interstitial Fibrosis, Pulmonary Disease and Interstitial Lung Disease, sponsored by Federal University of Minas Gerais. Completed at 2 sites in Brazil. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-03.

Sponsored by Federal University of Minas Gerais · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Not applicable
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Interstitial Fibrosis
  • Pulmonary Disease
  • Interstitial Lung Disease
  • Sarcoidosis
  • Idiopathic Pulmonary Fibrosis
  • Pneumonia, Interstitial

Keywords

  • Inspiratory muscle training
  • Interstitial lung disease
  • Inspiratory muscle endurance
  • Breathless
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

This study's enrollment of 14 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.

Browse Lung Diseases studies →

Lead sponsor

Federal University of Minas Gerais is the lead sponsor of 150 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Inability of the participant to understand or perform the procedures proposed during the evaluations and training program.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • 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

Interventions

  • OtherInspiratory muscle training

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

06

What researchers measure

Primary outcomes

  1. Change in Inspiratory muscle endurance

    Endurance time in seconds

    Time frame: At baseline and after 8 weeks of training

  2. Change in Breathlessness

    Medical Research Council (1-5)

    Time frame: At baseline and after 8 weeks of training

Secondary outcomes

  1. Change in Inspiratory muscle strength

    Maximal inspiratory pressure in cmH20

    Time frame: At baseline and after 8 weeks of training

  2. Change in Functional capacity

    Maximal distance in 6 minute walk test

    Time frame: At baseline and after 8 weeks of training

  3. 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.

    Time frame: At baseline and after 8 weeks of training

07

Study locations

2 sites
  • Ambulatório Bias Fortes - Ambulatório de Doenças Intersticiais do Hospital das Clínicas da Universidade Federal de Minas Gerais.
    Belo Horizonte, Minas Gerais 30150-260, Brazil
  • Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG
    Belo Horizonte, Minas Gerais 31270-901, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04481074
Lead sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Responsible party
Veronica Franco Parreira (Full Professor, Federal University of Minas Gerais) — Principal investigator
First posted
Jul 22, 2020
Start date
Jul 30, 2020
Primary completion
Apr 30, 2021
Completion
Apr 30, 2021
Last update
Feb 3, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion