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Completed

NCT Number: NCT03511287

Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease

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.

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Key information

Conditions

Lung Diseases Pulmonary Disease Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar, Belo Horizonte, Minas Gerais, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of Minas Gerais

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do estado de Minas Gerais

Registry information

Official study 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

Acronym: IMTinALD

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2018
Registry last updated
Apr 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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