Lung DiseasesIMTinALDNCT03511287
Effects of Inspiratory Muscle Training in Patients With Advanced Lung Disease
A study testing Inspiratory Muscle Training in people with Lung Diseases and Pulmonary Disease, run by Federal University of Minas Gerais at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Pulmonary Disease
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesBrazil
- Study dates
- Jun 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- presented inspiratory muscle strength higher than 60 cmH2O or predicted value
- unable to follow commands related to the measurements or to the IMT
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Ambulatório Bias Fortes- Ambulatório de Doença Pulmonar Avançada e Pré Transplante Pulmonar
Belo Horizonte, Minas Gerais, 30150-260
Laboratório de Avaliação e Pesquisa em Desempenho Cardiorrespiratório da UFMG
Belo Horizonte, Minas Gerais, 31270-901
About this study
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
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.
Read the 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.
- Conditions
- Lung Diseases, Pulmonary Disease
- Being tested
- Inspiratory Muscle Training
- Keywords
- inspiratory muscle training, advanced lung disease, maximal inspiratory pressure, inspiratory endurance
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
Breathing through a device that offers resistance during inspiration. In this study the POWERbreathe device was used (POWERbreathe® K3, HaB International Ltd, UK).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inspiratory muscle strength
Maximal inspiratory pressure in cmH2O
Measured: 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
Measured: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Secondary outcomes (6)
Change in Lung Function
Spirometry
Measured: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Change in Breathing pattern
Optoelectronic plethysmography (percentage of contribution of the 3 lung compartments to ventilation)
Measured: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Change in chest wall motion
Optoelectronic plethysmography (lung volumes in liters)
Measured: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Change in Functional Capacity (direct measure)
Six minutes walking distance (meters)
Measured: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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.
Measured: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
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.
Measured: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study startJun 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients from the advanced lung disease and pre lung transplantation ambulatory
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- 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.
- Responsible party
- Principal investigator, Veronica Franco Parreira, Federal University of Minas Gerais
- Investigators
- Veronica Parreira, PhD, Principal investigator, UFMG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511287
- Sponsor's protocol ID
- CNPq 442973/2014-4
- Acronym
- IMTinALD
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03511287
- Acronym / sponsor ID
- IMTinALD / CNPq 442973/2014-4
- Conditions
- Lung Diseases, Pulmonary Disease
- Keywords
- inspiratory muscle training, advanced lung disease, maximal inspiratory pressure, inspiratory endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- 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.
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 27 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients from the advanced lung disease and pre lung transplantation ambulatory
| Arm | Type | Receives |
|---|---|---|
| IMT group | Experimental | Other: Inspiratory Muscle TrainingGroup 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- presented inspiratory muscle strength higher than 60 cmH2O or predicted value
- unable to follow commands related to the measurements or to the IMT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingBreathing through a device that offers resistance during inspiration. In this study the POWERbreathe device was used (POWERbreathe® K3, HaB International Ltd, UK). | Other | IMT group |
Primary outcome
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
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
6 secondary outcomes
Change in Lung Function
Time frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Change in Breathing pattern
Time frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Change in chest wall motion
Time frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Change in Functional Capacity (direct measure)
Time frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Change in Functional Capacity (inderect measure)
Time frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Quality of life
Time frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veronica Parreira, PhD principal investigator
UFMG
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Lung Diseases and Pulmonary Disease, run by Federal University of Minas Gerais at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inspiratory muscle strength (time frame: Before intervention, after 8 weeks intervention and follow-up (3 months after the end of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2018.