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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04603963
Other study ID # 34931220.1.0000.0071
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date October 23, 2020

Study information

Verified date October 2020
Source Hospital Israelita Albert Einstein
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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%.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 55
Est. completion date October 23, 2020
Est. primary completion date October 10, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Device:
power breathe
respiratory muscle training 1 time a day with power breathe 3 sets of 10 repetitions

Locations

Country Name City State
Brazil Municipal Hospital Vila Santa Catarina São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Elaine Cristina Pereira <elaine.cpereira@einstein.br>

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary impact on functionality respiratory muscle training appears to impact functionality 14 days
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