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

Sponsor

Federal University of Minas Gerais (Other)

Overall Status

Completed

CT.gov ID

NCT04481074

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior. (Other)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Interstitial Fibrosis Pulmonary Disease Interstitial Lung Disease Sarcoidosis Idiopathic Pulmonary Fibrosis Pneumonia, Interstitial	Other: Inspiratory muscle training	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Quasi-experimentalQuasi-experimental

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Jul 30, 2020

Actual Primary Completion Date :

Apr 30, 2021

Actual Study Completion Date :

Apr 30, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ambulatório Bias Fortes - Ambulatório de Doenças Intersticiais do Hospital das Clínicas da Universidade Federal de Minas Gerais.	Belo Horizonte	Minas Gerais	Brazil	30150-260
2	Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG	Belo Horizonte	Minas Gerais	Brazil	31270-901