Inspiratory Muscle Training in Patients With COVID-19

NCT04603963 | Terminated

• 1 other identifier: 34931220.1.0000.0071
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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%.

Conditions

Covid19; Respiratory Disease

Keywords

physiotherapy; exercises; respiratory muscle training

Outcome Measures

Primary Outcomes (1)

• impact on functionality

  respiratory muscle training appears to impact functionality

  14 days

Study Arms (2)

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

power breathe DEVICE

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

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients diagnosed with COVID-19 through PCR aged over 18 years admitted to non-critical units.

You may not qualify if:

• patients with changes in the level of consciousness and non-transient understanding, exclusive palliative care without prognosis.

Sponsors & Collaborators

• Elaine Cristina Pereira <elaine.cpereira@einstein.br>: lead

Study Sites (1)

Municipal Hospital Vila Santa Catarina

São Paulo, 04377035, Brazil

Location

MeSH Terms

Conditions

COVID-19; Respiration Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Stratified randomization was performed in which the impaired chest tomography (absent, less than 50% or greater than 50%)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: October 25, 2020
• First Posted: October 27, 2020
• Study Start: June 1, 2020
• Primary Completion: October 10, 2020
• Study Completion: October 23, 2020
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

BR (1)