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Inspiratory Muscle Training in Patients With COVID-19

NCT ID: NCT04603963

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-10-23

Brief Summary

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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

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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

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Covid19 Respiratory Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Stratified randomization was performed in which the impaired chest tomography (absent, less than 50% or greater than 50%)

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

power breathe

Intervention Type DEVICE

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

Interventions

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power breathe

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Elaine Cristina Pereira <[email protected]>

OTHER

Sponsor Role lead

Responsible Party

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Elaine Cristina Pereira <[email protected]>

physiotherapist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Municipal Hospital Vila Santa Catarina

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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34931220.1.0000.0071

Identifier Type: -

Identifier Source: org_study_id