Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease

NCT ID: NCT03511287

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-12-31

Brief Summary

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The aim of this clinical trial is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease. Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention.

Detailed Description

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Inspiratory Muscle Training (IMT) should be considered an additional intervention in the pulmonary rehabilitation program for patients with advanced lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle training program in inspiratory muscle function, functional capacity, quality of life, lung function, breathing pattern and chest wall motion in patients with advanced lung disease. It is a quasi-experimental study with longitudinal design. Patients with advanced lung disease from the advanced lung disease and pre lung transplantation ambulatory performed home-based high intensity interval IMT for 8 weeks (two sessions per day, daily). In each session patients executed two times 30 breaths with one-minute rest between them. Resistance was set to the highest tolerable according to scores pointed by the patient on the Borg score (between 4 and 6) aiming 50% of actual pimax or higher. An experienced physiotherapist was responsible for weekly adjustments on the resistance of training as well as new assessment of maximal inspiratory pressure. Patients were evaluated before the inspiratory muscle training, after 8 weeks of training and at follow-up which was performed 3 months after the end of the intervention. Patients were evaluated by the same experienced researcher in all three moments of the study. Evaluations were performed in the Laboratory of research and evaluation of cardiorespiratory performance of Federal University of Minas Gerais.

Conditions

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Lung Diseases Pulmonary Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients from the advanced lung disease and pre lung transplantation ambulatory
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IMT group

Group intervention: home-based interval inspiratory muscle training:

* during 8 weeks (two sessions per day, daily)
* two times 30 breaths with one-minute rest between them in each session
* training resistance set to the highest tolerable load according to scores pointed by the patient on the Borg score (between 4 and 6) aiming 50% of actual pimax or higher adjusted in the supervised weekly session

Group Type EXPERIMENTAL

Inspiratory Muscle Training

Intervention Type OTHER

Breathing through a device that offers resistance during inspiration. In this study the POWERbreathe device was used (POWERbreathe® K3, HaB International Ltd, UK).

Interventions

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Inspiratory Muscle Training

Breathing through a device that offers resistance during inspiration. In this study the POWERbreathe device was used (POWERbreathe® K3, HaB International Ltd, UK).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* presence of inspiratory muscle weakness (Maximal Inspiratory Pressure - MIP ≤ 60 cmH2O or below the reference values proposed for the Brazilian population.
* completion of a 36 sessions of PR or nonattendance in any pulmonary rehabilitation by the time of inclusion and no perspective of initiating it in the next 8 weeks.
* absence of pre-existing neuromuscular, infectious, metabolic, psychiatric diseases or orthopedic problems that prevent from activities of daily living.

Exclusion Criteria

* presented inspiratory muscle strength higher than 60 cmH2O or predicted value
* unable to follow commands related to the measurements or to the IMT
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role collaborator

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role collaborator

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Veronica Franco Parreira

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Veronica Parreira, PhD

Role: PRINCIPAL_INVESTIGATOR

UFMG

Locations

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Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar

Belo Horizonte, Minas Gerais, Brazil

Site Status

Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CNPq 442973/2014-4

Identifier Type: -

Identifier Source: org_study_id

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