Covid19NCT04603963
Inspiratory Muscle Training in Patients With COVID-19
A study testing power breathe in people with Covid19 and Respiratory Disease, run by Elaine Cristina Pereira <elaine.cpereira@einstein.br> at 1 site in Brazil.
Trial summary
COVID 19 has become a pandemic and has led to high demand on healthcare systems. It can cause a severe acute respiratory syndrome (SARS CoV-2) which leads to a long hospital stay, developing important functional damage and making hospital discharge difficult. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Respiratory Disease
- What is being tested?
- power breathe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2020to 23 Oct 2020
- 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
- patients diagnosed with COVID-19 through PCR aged over 18 years admitted to non-critical units.
Who cannot join
- patients with changes in the level of consciousness and non-transient understanding, exclusive palliative care without prognosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efects of Inspiratory Muscle Training in Patients With COVID-19 After Acute Phase. Prospective Study
COVID 19 has become a pandemic and has led to high demand on healthcare systems. It can cause a severe acute respiratory syndrome (SARS CoV-2) which leads to a long hospital stay, developing important functional damage and making hospital discharge difficult. Elderly, obese and people with chronic diseases are more susceptible to contracting the disease, this profile of patients already has a predisposition for respiratory muscle weakness and in this context, after clinical stability, it is still necessary in a hospital environment to approach respiratory and motor physiotherapy. to optimize the recovery of these patients. Objective: Improved breathing, functionality, exercise capacity and muscle strength in non-critical patients. Method: Prospective randomized clinical study where one group received motor and respiratory physiotherapy and the other group performed the same therapy associated with inspiratory muscle training. Results: The findings will be compared before and after the approach and will be presented in graphs and tables. Statistical tests will be used considering a significance level of 5%.
Read the detailed description
Prospective clinical study in patients with COVID-19 admitted to a non-critical unit of a tertiary hospital. They were randomized into a group that received motor and respiratory exercises and another group that received the same exercises associated with respiratory muscle training.
- Conditions
- Covid19, Respiratory Disease
- Being tested
- power breathe
- Keywords
- physiotherapy, exercises, respiratory muscle training
- Medical subject headings
- COVID-19, Respiration Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
power breatheDevice
respiratory muscle training 1 time a day with power breathe 3 sets of 10 repetitions
| Study group | Role | What they receive |
|---|---|---|
| group control | No intervention | alternate exercises: in one day breathing exercises, active or with a load of large muscle groups (according to tolerance) with a maximum limit of 2 kg, sedation out of bed, walking. On another day aerobic exercise with cycle ergometer limited to 30 minutes. |
| intervention group | Experimental | He received the same intervention as the control group, associating respiratory muscle training 1 time a day with power breathe 3 series of 10 repetitions (started with 30% of the Pimax value) with readjusted load every 7 days. Receives: Device: power breathe |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact on functionality
respiratory muscle training appears to impact functionality
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Jun 2020
- Primary completion10 Oct 2020
- Study completion23 Oct 2020
Why it stopped: There was a change in the institutional flow reducing the cases of covid 19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Only patients with respiratory muscle weakness that were considered as the maximum inspiratory pressure value (less than or equal to 60% of the predicted value) entered for randomization. Stratified randomization was performed in which the impaired chest tomography (absent, less than 50% or greater than 50%) was taken into account to be randomly allocated to the groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elaine Cristina Pereira <elaine.cpereira@einstein.br>
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elaine Cristina Pereira <elaine.cpereira@einstein.br>, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04603963
- Sponsor's protocol ID
- 34931220.1.0000.0071
- Status last verified
- Oct 2020
- First submitted
- 25 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efects of Inspiratory Muscle Training in Patients With COVID-19 After Acute Phase. Prospective Study
- ClinicalTrials.gov ID
- NCT04603963
- Acronym / sponsor ID
- 34931220.1.0000.0071
- Conditions
- Covid19, Respiratory Disease
- Keywords
- physiotherapy, exercises, respiratory muscle training
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There was a change in the institutional flow reducing the cases of covid 19
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Elaine Cristina Pereira <elaine.cpereira@einstein.br>University, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 10 Oct 2020 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 27 Oct 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.
COVID 19 has become a pandemic and has led to high demand on healthcare systems. It can cause a severe acute respiratory syndrome (SARS CoV-2) which leads to a long hospital stay, developing important functional damage and making hospital discharge difficult. Elderly, obese and people with chronic diseases are more susceptible to contracting the disease, this profile of patients already has a predisposition for respiratory muscle weakness and in this context, after clinical stability, it is still necessary in a hospital environment to approach respiratory and motor physiotherapy. to optimize the recovery of these patients. Objective: Improved breathing, functionality, exercise capacity and muscle strength in non-critical patients. Method: Prospective randomized clinical study where one group received motor and respiratory physiotherapy and the other group performed the same therapy associated with inspiratory muscle training. Results: The findings will be compared before and after the approach and will be presented in graphs and tables. Statistical tests will be used considering a significance level of 5%.
Detailed description
Prospective clinical study in patients with COVID-19 admitted to a non-critical unit of a tertiary hospital. They were randomized into a group that received motor and respiratory exercises and another group that received the same exercises associated with respiratory muscle training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Only patients with respiratory muscle weakness that were considered as the maximum inspiratory pressure value (less than or equal to 60% of the predicted value) entered for randomization. Stratified randomization was performed in which the impaired chest tomography (absent, less than 50% or greater than 50%) was taken into account to be randomly allocated to the groups.
| Arm | Type | Receives |
|---|---|---|
| group control | No intervention | –alternate exercises: in one day breathing exercises, active or with a load of large muscle groups (according to tolerance) with a maximum limit of 2 kg, sedation out of bed, walking. On another day aerobic exercise with cycle ergometer limited to 30 minutes. |
| intervention group | Experimental | Device: power breatheHe received the same intervention as the control group, associating respiratory muscle training 1 time a day with power breathe 3 series of 10 repetitions (started with 30% of the Pimax value) with readjusted load every 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with COVID-19 through PCR aged over 18 years admitted to non-critical units.
Key exclusion criteria (1 listed)
- patients with changes in the level of consciousness and non-transient understanding, exclusive palliative care without prognosis.
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 |
|---|---|---|
| power breatherespiratory muscle training 1 time a day with power breathe 3 sets of 10 repetitions | Device | intervention group |
Primary outcome
impact on functionality
Time frame: 14 days
respiratory muscle training appears to impact functionality
Results and safety
The study was stopped early (reason given: There was a change in the institutional flow reducing the cases of covid 19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing power breathe in people with Covid19 and Respiratory Disease, run by Elaine Cristina Pereira <elaine.cpereira@einstein.br> at 1 site 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 1 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: stopped early, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: There was a change in the institutional flow reducing the cases of covid 19). Results are not available in the source record.
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?
impact on functionality (time frame: 14 days). 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 28 Oct 2020.