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Inspiratory Muscle Training in Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04603963
Recruitment Status : Terminated (There was a change in the institutional flow reducing the cases of covid 19)
First Posted : October 27, 2020
Last Update Posted : October 28, 2020
Sponsor:
Information provided by (Responsible Party):
Elaine Cristina Pereira <elaine.cpereira@einstein.br>, Hospital Israelita Albert Einstein

Brief 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. 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%.

Condition or disease Intervention/treatment Phase
Covid19 Respiratory Disease Device: power breathe Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator)
Masking Description: Stratified randomization was performed in which the impaired chest tomography (absent, less than 50% or greater than 50%)
Primary Purpose: Treatment
Official Title: Efects of Inspiratory Muscle Training in Patients With COVID-19 After Acute Phase. Prospective Study
Actual Study Start Date : June 1, 2020
Actual Primary Completion Date : October 10, 2020
Actual Study Completion Date : October 23, 2020

Arm Intervention/treatment
No Intervention: group control
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.
Experimental: intervention group
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.
Device: power breathe
respiratory muscle training 1 time a day with power breathe 3 sets of 10 repetitions




Primary Outcome Measures :
  1. impact on functionality [ Time Frame: 14 days ]
    respiratory muscle training appears to impact functionality



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients diagnosed with COVID-19 through PCR aged over 18 years admitted to non-critical units.

Exclusion Criteria:

  • patients with changes in the level of consciousness and non-transient understanding, exclusive palliative care without prognosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04603963


Locations
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Brazil
Municipal Hospital Vila Santa Catarina
São Paulo, Brazil, 04377035
Sponsors and Collaborators
Elaine Cristina Pereira <elaine.cpereira@einstein.br>
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Responsible Party: Elaine Cristina Pereira <elaine.cpereira@einstein.br>, physiotherapist, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT04603963    
Other Study ID Numbers: 34931220.1.0000.0071
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Elaine Cristina Pereira <elaine.cpereira@einstein.br>, Hospital Israelita Albert Einstein:
physiotherapy
exercises
respiratory muscle training
Additional relevant MeSH terms:
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COVID-19
Respiration Disorders
Respiratory Tract Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases