search
Back to results

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

Primary Purpose

Interstitial Fibrosis, Pulmonary Disease, Interstitial Lung Disease

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle training
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Interstitial Fibrosis focused on measuring Inspiratory muscle training, Interstitial lung disease, Inspiratory muscle endurance, Breathless

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ambulatório Bias Fortes - Ambulatório de Doenças Intersticiais do Hospital das Clínicas da Universidade Federal de Minas Gerais.
  • Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inspiratory muscle training group

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Inspiratory muscle endurance
Endurance time in seconds
Change in Breathlessness
Medical Research Council (1-5)

Secondary Outcome Measures

Change in Inspiratory muscle strength
Maximal inspiratory pressure in cmH20
Change in Functional capacity
Maximal distance in 6 minute walk test
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.

Full Information

First Posted
July 17, 2020
Last Updated
February 2, 2022
Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
search

1. Study Identification

Unique Protocol Identification Number
NCT04481074
Brief Title
Inspiratory Muscle Training in Patients With Interstitial Lung Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Fibrosis, Pulmonary Disease, Interstitial Lung Disease, Sarcoidosis, Idiopathic Pulmonary Fibrosis, Pneumonia, Interstitial
Keywords
Inspiratory muscle training, Interstitial lung disease, Inspiratory muscle endurance, Breathless

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi-experimental
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle training
Intervention Description
Inspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®).
Primary Outcome Measure Information:
Title
Change in Inspiratory muscle endurance
Description
Endurance time in seconds
Time Frame
At baseline and after 8 weeks of training
Title
Change in Breathlessness
Description
Medical Research Council (1-5)
Time Frame
At baseline and after 8 weeks of training
Secondary Outcome Measure Information:
Title
Change in Inspiratory muscle strength
Description
Maximal inspiratory pressure in cmH20
Time Frame
At baseline and after 8 weeks of training
Title
Change in Functional capacity
Description
Maximal distance in 6 minute walk test
Time Frame
At baseline and after 8 weeks of training
Title
Change in Quality of life
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ambulatório Bias Fortes - Ambulatório de Doenças Intersticiais do Hospital das Clínicas da Universidade Federal de Minas Gerais.
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-260
Country
Brazil
Facility Name
Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
31270-901
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Inspiratory Muscle Training in Patients With Interstitial Lung Disease

We'll reach out to this number within 24 hrs