Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease

NCT03511287 | Completed

• 1 other identifier: CNPq 442973/2014-4
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Diseases; Pulmonary Disease

Keywords

inspiratory muscle training; advanced lung disease; maximal inspiratory pressure; inspiratory endurance

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• Change in Lung Function

  Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)

• Change in Breathing pattern

  Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)

• Change in chest wall motion

  Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)

• Change in Functional Capacity (direct measure)

  Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)

• Change in Functional Capacity (inderect measure)

  Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)

Study Arms (1)

IMT group

EXPERIMENTAL

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

Interventions

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).

IMT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• presence of inspiratory muscle weakness (Maximal Inspiratory Pressure - MIP ≤ 60 cmH2O or below the reference values proposed for the Brazilian population.
• absence of pre-existing neuromuscular, infectious, metabolic, psychiatric diseases or orthopedic problems that prevent from activities of daily living.

You may not qualify if:

• presented inspiratory muscle strength higher than 60 cmH2O or predicted value
• unable to follow commands related to the measurements or to the IMT

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator

Study Sites (2)

Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar

Belo Horizonte, Minas Gerais, 30150-260, Brazil

Location

Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG

Belo Horizonte, Minas Gerais, 31270-901, Brazil

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Veronica Parreira, PhD

  UFMG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: All patients from the advanced lung disease and pre lung transplantation ambulatory

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 27, 2018
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: April 27, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)