Interstitial FibrosisIMT-ILDNCT04481074
Inspiratory Muscle Training in Patients With Interstitial Lung Disease
A study testing Inspiratory muscle training in people with Interstitial Fibrosis and Pulmonary Disease, run by Federal University of Minas Gerais at 2 sites in Brazil.
Trial summary
The aim of this study is to evaluate the effects of inspiratory muscle training program in inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Interstitial Fibrosis, Pulmonary Disease, Interstitial Lung Disease
- What is being tested?
- Inspiratory muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 2 sitesBrazil
- Study dates
- 30 Jul 2020to 30 Apr 2021
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological diagnosis of interstitial lung disease established by a pulmonologist;
- Absence of clinical exacerbations of the disease in the four weeks prior to the initial data collection;
- Present medical research council scale more than 2;
- Absence of a associated or self reported cardiac, orthopedic and psychiatric diseases,
- Not participating in pulmonary rehabilitation programs;
- Do not use supplemental oxygen therapy while resting.
Who cannot join
- Inability of the participant to understand or perform the procedures proposed during the evaluations and training program.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Ambulatório Bias Fortes - Ambulatório de Doenças Intersticiais do Hospital das Clínicas da Universidade Federal de Minas Gerais.
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 Endurance, Breathlessness, Inspiratory Muscle Strength, Functional Capacity and Quality of Life in Patients With Interstitial Lung Disease
The aim of this study is to evaluate the effects of inspiratory muscle training program in inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
Read the detailed description
Inspiratory Muscle Training has been described as an effective intervention and contribute to the improvement of inspiratory muscle function and breathlessness in patients with chronic lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. It is a quasi-experimental study. Patients with interstitial lung disease are recruited from interstitial disease ambulatory. In each session patients performs two times 30 breaths with a minute rest between them. The load is set according with 50% of actual PImax, the Borg score should be between 4 and 6, otherwise the load will decrease (if Borg more than 6) or increase (if Borg less than 4). New PImax is measured weekly and the new load is defined following the same protocol for 8 weeks. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
- Conditions
- Interstitial Fibrosis, Pulmonary Disease, Interstitial Lung Disease, Sarcoidosis, Idiopathic Pulmonary Fibrosis, Pneumonia, Interstitial
- Being tested
- Inspiratory muscle training
- Keywords
- Inspiratory muscle training, Interstitial lung disease, Inspiratory muscle endurance, Breathless
- Medical subject headings
- Pulmonary Fibrosis, Lung Diseases, Lung Diseases, Interstitial, Sarcoidosis, Idiopathic Pulmonary Fibrosis, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle trainingOther
Inspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®).
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training group | Experimental | Group intervention: home-based interval inspiratory muscle training during 8 weeks, two sessions with two sets of 30 breaths with one minute rest between them. Load set is determinated weekly, aiming 50% of actual PImax and according to Borg Score. 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 endurance
Endurance time in seconds
Measured: At baseline and after 8 weeks of training
Change in Breathlessness
Medical Research Council (1-5)
Measured: At baseline and after 8 weeks of training
Secondary outcomes (3)
Change in Inspiratory muscle strength
Maximal inspiratory pressure in cmH20
Measured: At baseline and after 8 weeks of training
Change in Functional capacity
Maximal distance in 6 minute walk test
Measured: At baseline and after 8 weeks of training
Change in Quality of life
King's Brief Interstitial Lung Disease Questionnaire. It is a 15 questions questionnaire. Total score can go from 0 - 100, 100 is the better quality of life.
Measured: At baseline and after 8 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start30 Jul 2020
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial FibrosisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental
- Masking
- None (open label)
- Enrolment
- 14 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, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Veronica Franco Parreira, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481074
- Sponsor's protocol ID
- UFMG_IMT-ILD
- Acronym
- IMT-ILD
- Status last verified
- Feb 2022
- First submitted
- 17 Jul 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training in Inspiratory Muscle Endurance, Breathlessness, Inspiratory Muscle Strength, Functional Capacity and Quality of Life in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT04481074
- Acronym / sponsor ID
- IMT-ILD / UFMG_IMT-ILD
- Conditions
- Interstitial Fibrosis, Pulmonary Disease, Interstitial Lung Disease, Sarcoidosis, Idiopathic Pulmonary Fibrosis, Pneumonia, Interstitial
- Keywords
- Inspiratory muscle training, Interstitial lung disease, Inspiratory muscle endurance, Breathless
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 22 Jul 2020 (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 study is to evaluate the effects of inspiratory muscle training program in inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
Detailed description
Inspiratory Muscle Training has been described as an effective intervention and contribute to the improvement of inspiratory muscle function and breathlessness in patients with chronic lung disease. The aim of this study is to evaluate, the effects of inspiratory muscle endurance, breathlessness, inspiratory muscle strength, functional capacity and quality of life in patients with interstitial lung disease. It is a quasi-experimental study. Patients with interstitial lung disease are recruited from interstitial disease ambulatory. In each session patients performs two times 30 breaths with a minute rest between them. The load is set according with 50% of actual PImax, the Borg score should be between 4 and 6, otherwise the load will decrease (if Borg more than 6) or increase (if Borg less than 4). New PImax is measured weekly and the new load is defined following the same protocol for 8 weeks. Patients are evaluated before the inspiratory muscle training and after 8 weeks of training.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training group | Experimental | Other: Inspiratory muscle trainingGroup intervention: home-based interval inspiratory muscle training during 8 weeks, two sessions with two sets of 30 breaths with one minute rest between them. Load set is determinated weekly, aiming 50% of actual PImax and according to Borg Score. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical and radiological diagnosis of interstitial lung disease established by a pulmonologist;
- Absence of clinical exacerbations of the disease in the four weeks prior to the initial data collection;
- Present medical research council scale more than 2;
- Absence of a associated or self reported cardiac, orthopedic and psychiatric diseases,
- Not participating in pulmonary rehabilitation programs;
Key exclusion criteria (1 listed)
- Inability of the participant to understand or perform the procedures proposed during the evaluations and training program.
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 trainingInspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®). | Other | Inspiratory muscle training group |
Primary outcome
Change in Inspiratory muscle endurance
Time frame: At baseline and after 8 weeks of training
Endurance time in seconds
Change in Breathlessness
Time frame: At baseline and after 8 weeks of training
Medical Research Council (1-5)
3 secondary outcomes
Change in Inspiratory muscle strength
Time frame: At baseline and after 8 weeks of training
Change in Functional capacity
Time frame: At baseline and after 8 weeks of training
Change in Quality of life
Time frame: At baseline and after 8 weeks of training
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 3 Feb 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Interstitial Fibrosis 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 6 inclusion and 1 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 3 Feb 2022. 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 endurance (time frame: At baseline and after 8 weeks of training). 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 3 Feb 2022.