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Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease (IMTinALD)

Primary Purpose

Lung Diseases, Pulmonary 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 treatment trial for Lung Diseases focused on measuring inspiratory muscle training, advanced lung disease, maximal inspiratory pressure, inspiratory endurance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar
  • Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMT group

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Inspiratory muscle strength
Maximal inspiratory pressure in cmH2O
Change in Inspiratory Muscle Endurance
Inspiratory endurance time in seconds

Secondary Outcome Measures

Change in Lung Function
Spirometry
Change in Breathing pattern
Optoelectronic plethysmography (percentage of contribution of the 3 lung compartments to ventilation)
Change in chest wall motion
Optoelectronic plethysmography (lung volumes in liters)
Change in Functional Capacity (direct measure)
Six minutes walking distance (meters)
Change in Functional Capacity (inderect measure)
London chest activity of daily living scale (total score) - It evaluates the dyspnea in daily activities. Consists in a 15 questions questionnaire with scores from 0-5 in each question. Total score varies from 0 to 75, the higher the score the major the limitation on daily activities due to dyspnea.
Quality of life
Saint George Respiratory questionnaire (total score) It is a 50 questions questionnaire. Total score can go from 0 to 100. Higher scores indicate worse quality of life.

Full Information

First Posted
April 11, 2018
Last Updated
April 18, 2018
Sponsor
Federal University of Minas Gerais
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT03511287
Brief Title
Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease
Acronym
IMTinALD
Official Title
Effects of Inspiratory Muscle Training in Inspiratory Muscle Function, Functional Capacity, Quality of Life, Lung Function, Breathing Pattern and Thoracoabdominal Motion in Patients With Advanced Lung Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (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, Fundação de Amparo à Pesquisa do estado de Minas Gerais, 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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Pulmonary Disease
Keywords
inspiratory muscle training, advanced lung disease, maximal inspiratory pressure, inspiratory endurance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients from the advanced lung disease and pre lung transplantation ambulatory
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMT group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
Breathing through a device that offers resistance during inspiration. In this study the POWERbreathe device was used (POWERbreathe® K3, HaB International Ltd, UK).
Primary Outcome Measure Information:
Title
Change in Inspiratory muscle strength
Description
Maximal inspiratory pressure in cmH2O
Time Frame
Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Title
Change in Inspiratory Muscle Endurance
Description
Inspiratory endurance time in seconds
Time Frame
Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Secondary Outcome Measure Information:
Title
Change in Lung Function
Description
Spirometry
Time Frame
Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Title
Change in Breathing pattern
Description
Optoelectronic plethysmography (percentage of contribution of the 3 lung compartments to ventilation)
Time Frame
Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Title
Change in chest wall motion
Description
Optoelectronic plethysmography (lung volumes in liters)
Time Frame
Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Title
Change in Functional Capacity (direct measure)
Description
Six minutes walking distance (meters)
Time Frame
Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Title
Change in Functional Capacity (inderect measure)
Description
London chest activity of daily living scale (total score) - It evaluates the dyspnea in daily activities. Consists in a 15 questions questionnaire with scores from 0-5 in each question. Total score varies from 0 to 75, the higher the score the major the limitation on daily activities due to dyspnea.
Time Frame
Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Title
Quality of life
Description
Saint George Respiratory questionnaire (total score) It is a 50 questions questionnaire. Total score can go from 0 to 100. Higher scores indicate worse quality of life.
Time Frame
Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Parreira, PhD
Organizational Affiliation
UFMG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar
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

Plan to Share IPD
No

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Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease

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