Clinical trial NCT03511287: Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease
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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Pulmonary Disease
Keywords: inspiratory muscle training
advanced lung disease
maximal inspiratory pressure
inspiratory endurance
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2018-04-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients from the advanced lung disease and pre lung transplantation ambulatory
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Inspiratory muscle strength
timeFrame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
measure: Change in Inspiratory Muscle Endurance
timeFrame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Secondary outcomes:
measure: Change in Lung Function
timeFrame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
measure: Change in Breathing pattern
timeFrame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
measure: Change in chest wall motion
timeFrame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
measure: Change in Functional Capacity (direct measure)
timeFrame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
measure: Change in Functional Capacity (inderect measure)
timeFrame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
measure: Quality of life
timeFrame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar
state: Minas Gerais
city: Belo Horizonte
country: Brazil
facility: Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG
state: Minas Gerais
Study officials:
affiliation: UFMG
name: Veronica Parreira, PhD
role: PRINCIPAL_INVESTIGATOR
References: