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Inspiratory Muscle Training in Patients With COVID-19

Primary Purpose

Covid19, Respiratory Disease

Status
Terminated
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
power breathe
Sponsored by
Elaine Cristina Pereira <elaine.cpereira@einstein.br>
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring physiotherapy, exercises, respiratory muscle training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Municipal Hospital Vila Santa Catarina

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

group control

intervention group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

impact on functionality
respiratory muscle training appears to impact functionality

Secondary Outcome Measures

Full Information

First Posted
October 25, 2020
Last Updated
October 26, 2020
Sponsor
Elaine Cristina Pereira <elaine.cpereira@einstein.br>
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1. Study Identification

Unique Protocol Identification Number
NCT04603963
Brief Title
Inspiratory Muscle Training in Patients With COVID-19
Official Title
Efects of Inspiratory Muscle Training in Patients With COVID-19 After Acute Phase. Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Terminated
Why Stopped
There was a change in the institutional flow reducing the cases of covid 19
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
October 10, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Elaine Cristina Pereira <elaine.cpereira@einstein.br>

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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%.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Respiratory Disease
Keywords
physiotherapy, exercises, respiratory muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Investigator
Masking Description
Stratified randomization was performed in which the impaired chest tomography (absent, less than 50% or greater than 50%)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group control
Arm Type
No Intervention
Arm Description
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.
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
power breathe
Intervention Description
respiratory muscle training 1 time a day with power breathe 3 sets of 10 repetitions
Primary Outcome Measure Information:
Title
impact on functionality
Description
respiratory muscle training appears to impact functionality
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Municipal Hospital Vila Santa Catarina
City
São Paulo
ZIP/Postal Code
04377035
Country
Brazil

12. IPD Sharing Statement

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Inspiratory Muscle Training in Patients With COVID-19

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