Inspiratory Muscle Training in Patients With COVID-19 | NCT04603963

Studies
Inspiratory Muscle Training in Patients With COVID-19

NCT04603963

Sponsor

Elaine Cristina Pereira <elaine.cpereira@einstein.br>

Status

Terminated

Last Update Posted

Oct 28, 2020Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Covid19
Respiratory Disease

Interventions

power breathe

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

There was a change in the institutional flow reducing the cases of covid 19

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Oct 10, 2020Actual

Completion Date

Oct 23, 2020Actual

First Submitted Date

Oct 25, 2020

First Submission Date that Met QC Criteria

Oct 26, 2020

First Posted Date

Oct 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2020

Last Update Posted Date

Oct 28, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elaine Cristina Pereira <elaine.cpereira@einstein.br>, physiotherapist, Hospital Israelita Albert EinsteinSponsor-Investigator

Lead Sponsor

Elaine Cristina Pereira <elaine.cpereira@einstein.br>OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group control	No Intervention	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.
intervention group	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
power breathe	Device	respiratory muscle training 1 time a day with power breathe 3 sets of 10 repetitions	intervention group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
impact on functionality	respiratory muscle training appears to impact functionality	14 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Municipal Hospital Vila Santa Catarina		São Paulo		04377035	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D012120	Respiration Disorders
D009043	Motor Activity

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

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.