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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03511287
Recruitment Status : Completed
First Posted : April 27, 2018
Last Update Posted : April 27, 2018
Sponsor:
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.
Information provided by (Responsible Party):
Veronica Franco Parreira, Federal University of Minas Gerais

Study Description
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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.

Condition or disease Intervention/treatment Phase
Lung Diseases Pulmonary Disease Other: Inspiratory Muscle Training Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All patients from the advanced lung disease and pre lung transplantation ambulatory
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Other: 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).


Outcome Measures
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Primary Outcome Measures :
  1. Change in Inspiratory muscle strength [ Time Frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) ]
    Maximal inspiratory pressure in cmH2O

  2. Change in Inspiratory Muscle Endurance [ Time Frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) ]
    Inspiratory endurance time in seconds


Secondary Outcome Measures :
  1. Change in Lung Function [ Time Frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) ]
    Spirometry

  2. Change in Breathing pattern [ Time Frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) ]
    Optoelectronic plethysmography (percentage of contribution of the 3 lung compartments to ventilation)

  3. Change in chest wall motion [ Time Frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) ]
    Optoelectronic plethysmography (lung volumes in liters)

  4. Change in Functional Capacity (direct measure) [ Time Frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) ]
    Six minutes walking distance (meters)

  5. Change in Functional Capacity (inderect measure) [ Time Frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) ]
    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.

  6. Quality of life [ Time Frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention) ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511287


Locations
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Brazil
Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar
Belo Horizonte, Minas Gerais, Brazil, 30150-260
Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG
Belo Horizonte, Minas Gerais, Brazil, 31270-901
Sponsors and Collaborators
Federal University of Minas Gerais
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.
Investigators
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Principal Investigator: Veronica Parreira, PhD UFMG
More Information
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Responsible Party: Veronica Franco Parreira, Full Professor, Federal University of Minas Gerais
ClinicalTrials.gov Identifier: NCT03511287    
Other Study ID Numbers: CNPq 442973/2014-4
First Posted: April 27, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Veronica Franco Parreira, Federal University of Minas Gerais:
inspiratory muscle training
advanced lung disease
maximal inspiratory pressure
inspiratory endurance
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Aspiration
Respiratory Tract Diseases
Respiration Disorders
Pathologic Processes