Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease

Lung Diseases Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03511287
• Other study ID #: CNPq 442973/2014-4
• Status: Completed
• Phase: N/A
• First received: April 11, 2018
• Last updated: April 18, 2018
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2018
• Source: Federal University of Minas Gerais
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases
• Pulmonary Disease
• Respiratory Aspiration

Intervention

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).

Locations

Country	Name	City	State
Brazil	Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar	Belo Horizonte	Minas Gerais
Brazil	Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG	Belo Horizonte	Minas Gerais

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of Minas Gerais	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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Inspiratory muscle strength	Maximal inspiratory pressure in cmH2O	Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Primary	Change in Inspiratory Muscle Endurance	Inspiratory endurance time in seconds	Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Secondary	Change in Lung Function	Spirometry	Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Secondary	Change in Breathing pattern	Optoelectronic plethysmography (percentage of contribution of the 3 lung compartments to ventilation)	Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Secondary	Change in chest wall motion	Optoelectronic plethysmography (lung volumes in liters)	Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Secondary	Change in Functional Capacity (direct measure)	Six minutes walking distance (meters)	Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Secondary	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.	Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Secondary	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.	Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)