Inspiratory Muscle Training in Patients With COVID-19

• Sponsor: Elaine Cristina Pereira <[e-mail]> (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04603963
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.7
• Patients Per Site Per Month: 11.6

Study Details

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%.

Condition or Disease	Intervention/Treatment	Phase
Covid19; Respiratory Disease	Device: power breathe	N/A

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

• Study Type: Interventional
• 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.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: Jun 1, 2020
• Actual Primary Completion Date: Oct 10, 2020
• Actual Study Completion Date: Oct 23, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. impact on functionality [14 days]

   respiratory muscle training appears to impact functionality

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Municipal Hospital Vila Santa Catarina	São Paulo		Brazil	04377035

Sponsors and Collaborators

• Elaine Cristina Pereira <[e-mail]>

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elaine Cristina Pereira <[e-mail]>, physiotherapist, Hospital Israelita Albert Einstein
• ClinicalTrials.gov Identifier: NCT04603963
• Other Study ID Numbers: 34931220.1.0000.0071
• First Posted: Oct 27, 2020
• Last Update Posted: Oct 28, 2020
• Last Verified: Oct 1, 2020

• 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 <[e-mail]>, physiotherapist, Hospital Israelita Albert Einstein: physiotherapy; exercises; respiratory muscle training
• Additional relevant MeSH terms: COVID-19; Respiration Disorders; Respiratory Tract Diseases

Study Results

No Results Posted as of Oct 28, 2020