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Inspiratory Muscle Training in COVID-19 Patients (ADDIMTCOVID)

Primary Purpose

Covid19, Exercise

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
inspiratory muscle traiing
Sponsored by
Escola Superior de Ciencias da Saude
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring respiratory function tests, inspiratory muscle training

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be eligible, participants must be:

  • over 18 years of age
  • confirmed COVID-19 diagnosis
  • Individuals that required hospitalization and either i) non-invasive respiratory support (CPAP, high-flow oxygen catheter, non-breathing oxygen mask, or ii) invasive mechanical ventilation within three months of study recruitment.

Exclusion Criteria:

  • Pregnancy
  • Dependence on others to perform activities of daily living during the month prior to the current ICU admission (gait aids are acceptable)
  • documented cognitive impairment
  • Proven or suspected spinal cord injury, or other neuromuscular diseases that will result in a permanent or prolonged weakness (not including ICU acquired weakness)
  • Severe neurological disease
  • Death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision-maker are not committed to full active treatment.

Sites / Locations

  • Secretaria de Saúde do Distrito Federal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control group

Arm Description

The training volume will be 24 sessions. Training frequency will be 3 sessions per week. Duration of training sessions will be around 60min. Patients will perform endurance training or interval training at moderate to high intensities. IMT in both groups will be performed using the PowerBreathe KHP2 device (POWERbreatheKHP2, HaB, International, Southam, UK). Training intensity in the intervention group will be set initially at a load of 50% of patients' maximal inspiratory mouth pressure (MIP). This initial load will be continuously and gradually increased to the highest tolerable intensity during each of the supervised sessions.

The training volume will be 24 sessions. Training frequency will be 3 sessions per week. Duration of training sessions will be around 60min. Patients will perform endurance training or interval training at moderate to high intensities. Sham IMT will be performed using the PowerBreathe KHP2 device (POWERbreatheKHP2, HaB, International, Southam, UK). Training intensity in the control group will be set at 10% baseline PImax and will be not modified throughout the intervention period.

Outcomes

Primary Outcome Measures

Cardiopulmonary Exercise Testing Measurements
Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.The ventilatory anaerobic threshold (VAT) will be determined by the V-slope method.

Secondary Outcome Measures

severity of fatigue
Fatigue severity scale (FSS) is a questionnaire consisting of 9 questions showing the degree of fatigue of patients. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome
Anxiety and Depression
Hospital anxiety and depression scale (HADS) is a 14-item questionnaire for screening anxiety (7 items) and depression (7 items). Each item is scored from 0-3 (a 4-point severity scale). Highest anxiety or depression score is 21. Patients are defined as having anxiety or depression or both if the score is 8 or more in the each subscale.
incremental cost-utility ratio
Utility will be measured by Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.
Health- related quality of life
EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually
Pulmonary function testing
Spirometry will be performed with a spirometer (Microlab 3.500; CareFusion, Yorba Linda, CA, USA). Three forced expiration maneuvers will be performed for validity and reproducibility purposes according to ATS/ERS criteria, with patients sitting, in a room with controlled temperature, ambient pressure, and relative humidity. The following variables will be analyzed: (a) forced vital capacity (FVC, L), (b) forced expiratory volume in the first second (FEV1, L).
Dyspnea
The modified Medical Research Council Dyspnea Scale (mMRC). A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are to breathless to leave the house, or breathless when dressing/undressing.
Respiratory muscle strength
Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements
Postural Control
postural control assessed by stabilometry test
isometric knee extension strength
peripheral muscle stregnth assessed by isometric load dynamometer
displacement
outcomes assessed by baropodometry
trajectory
outcome assessed by baropodometry
isometric knee flexion strength
peripheral muscle stregnth assessed by isometric load dynamometer
dynamic balance
dynamic balance assessed by Mini-BEST testing
Sit to Stand Test
exercise capacity assessed by Sit to Stand test

Full Information

First Posted
October 19, 2020
Last Updated
September 13, 2023
Sponsor
Escola Superior de Ciencias da Saude
Collaborators
University of Brasilia, JBS/CNPq
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1. Study Identification

Unique Protocol Identification Number
NCT04595097
Brief Title
Inspiratory Muscle Training in COVID-19 Patients
Acronym
ADDIMTCOVID
Official Title
Adjunctive Inspiratory Muscle Training for Patients With COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Escola Superior de Ciencias da Saude
Collaborators
University of Brasilia, JBS/CNPq

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to investigate whether adjunctive inspiratory muscle training (IMT) can enhance the benefits of pulmonary rehabilitation (PR) in patients with COVID-19. 120 patients will be randomized into an interventional group (PR plus IMT) and a control group (sham IMT plus PR). Improvement in quality of life, peak VO2 and VE/VCO2 slope will be defined as a primary outcome. Maximal inspiratory pressure, inspiratory muscle endurance, pulmonary function testing, severity of fatigue, cost-effectiveness and six minute walk test will be defined as the secondary outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Exercise
Keywords
respiratory function tests, inspiratory muscle training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The training volume will be 24 sessions. Training frequency will be 3 sessions per week. Duration of training sessions will be around 60min. Patients will perform endurance training or interval training at moderate to high intensities. IMT in both groups will be performed using the PowerBreathe KHP2 device (POWERbreatheKHP2, HaB, International, Southam, UK). Training intensity in the intervention group will be set initially at a load of 50% of patients' maximal inspiratory mouth pressure (MIP). This initial load will be continuously and gradually increased to the highest tolerable intensity during each of the supervised sessions.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The training volume will be 24 sessions. Training frequency will be 3 sessions per week. Duration of training sessions will be around 60min. Patients will perform endurance training or interval training at moderate to high intensities. Sham IMT will be performed using the PowerBreathe KHP2 device (POWERbreatheKHP2, HaB, International, Southam, UK). Training intensity in the control group will be set at 10% baseline PImax and will be not modified throughout the intervention period.
Intervention Type
Device
Intervention Name(s)
inspiratory muscle traiing
Other Intervention Name(s)
tapered flow resistive loading
Intervention Description
The patients are encouraged to inhale against a load to increase the inspiratory muscle strength and endurance
Primary Outcome Measure Information:
Title
Cardiopulmonary Exercise Testing Measurements
Description
Peak VO2 is a measurement of oxygen consumption rate during exercise (milliliters of oxygen per minute). It is calculated by continuous measurement of oxygen consumed during exercise while patients breath through a mask/tube. To account for variability in patient size, the oxygen consumption is divided by patient body weight.The VE/VCO2 slope is calculated as the ratio of minute ventilation (VE) and carbon dioxide production (VCO2). Because these measurements share the same units, the resultant ratio is unitless.The ventilatory anaerobic threshold (VAT) will be determined by the V-slope method.
Time Frame
change from baseline in Peak VO2, VE/VCO2 slope and VAT at 8 weeks and 6 months
Secondary Outcome Measure Information:
Title
severity of fatigue
Description
Fatigue severity scale (FSS) is a questionnaire consisting of 9 questions showing the degree of fatigue of patients. An average score of less than 2.8 indicates no fatigue, and more than 6.1 indicates chronic fatigue syndrome
Time Frame
change from baseline in FSS score at 8 weeks and 6 months
Title
Anxiety and Depression
Description
Hospital anxiety and depression scale (HADS) is a 14-item questionnaire for screening anxiety (7 items) and depression (7 items). Each item is scored from 0-3 (a 4-point severity scale). Highest anxiety or depression score is 21. Patients are defined as having anxiety or depression or both if the score is 8 or more in the each subscale.
Time Frame
Change from baseline in HADS score at 8 weeks and 6 months
Title
incremental cost-utility ratio
Description
Utility will be measured by Quality Adjusted Life Year (QALYs) as estimated from responses to the Euroqol-5 Dimensions (EQ-5D 5L) health-related quality of life questionnaire. The questionnaire focuses on 5 dimensions: mobility, personal autonomy, current activities, pain/discomfort and anxiety/depression. For each of these dimensions, 5 answers are possible.
Time Frame
6 months
Title
Health- related quality of life
Description
EQ-5D is a standardized tool for the assessment of quality of life in 5 different dimensions (Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/Depression). Possible scores range from 1 (No problem) to 3 (Extreme problems) and each dimension are evaluated individually
Time Frame
change from baseline in EQ-5D score at 8 weeks and 6 months
Title
Pulmonary function testing
Description
Spirometry will be performed with a spirometer (Microlab 3.500; CareFusion, Yorba Linda, CA, USA). Three forced expiration maneuvers will be performed for validity and reproducibility purposes according to ATS/ERS criteria, with patients sitting, in a room with controlled temperature, ambient pressure, and relative humidity. The following variables will be analyzed: (a) forced vital capacity (FVC, L), (b) forced expiratory volume in the first second (FEV1, L).
Time Frame
change from baseline in FEV1 and FVC in Liters at 8 weeks and 6 months.
Title
Dyspnea
Description
The modified Medical Research Council Dyspnea Scale (mMRC). A score from 0-4 is used to classify the impact of dyspnea on physical function in patients with respiratory limitations. 0 represents a person who suffers from dyspnea only with strenuous exercise. 4 represents a person who are to breathless to leave the house, or breathless when dressing/undressing.
Time Frame
change from baseline in mMRC score at 8 weeks and 6 months
Title
Respiratory muscle strength
Description
Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements
Time Frame
change from baseline in MIP and MEP at 8 weeks and 6 months
Title
Postural Control
Description
postural control assessed by stabilometry test
Time Frame
change from baseline in Postural stability test and fall risk test at 8 weeks
Title
isometric knee extension strength
Description
peripheral muscle stregnth assessed by isometric load dynamometer
Time Frame
change from baseline in Nm at 8 weeks
Title
displacement
Description
outcomes assessed by baropodometry
Time Frame
change from baseline in CM2 at 8 weeks
Title
trajectory
Description
outcome assessed by baropodometry
Time Frame
change from baseline in CM2 at 8 weeks
Title
isometric knee flexion strength
Description
peripheral muscle stregnth assessed by isometric load dynamometer
Time Frame
change from baseline in Nm at 8 weeks
Title
dynamic balance
Description
dynamic balance assessed by Mini-BEST testing
Time Frame
change from baseline in Total score at 8 weeks
Title
Sit to Stand Test
Description
exercise capacity assessed by Sit to Stand test
Time Frame
change from baseline in repetitions at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be eligible, participants must be: over 18 years of age confirmed COVID-19 diagnosis Individuals that required hospitalization and either i) non-invasive respiratory support (CPAP, high-flow oxygen catheter, non-breathing oxygen mask, or ii) invasive mechanical ventilation within three months of study recruitment. Exclusion Criteria: Pregnancy Dependence on others to perform activities of daily living during the month prior to the current ICU admission (gait aids are acceptable) documented cognitive impairment Proven or suspected spinal cord injury, or other neuromuscular diseases that will result in a permanent or prolonged weakness (not including ICU acquired weakness) Severe neurological disease Death is deemed inevitable as a result of the current illness and either the patient or treating clinical or substitute decision-maker are not committed to full active treatment.
Facility Information:
Facility Name
Secretaria de Saúde do Distrito Federal
City
Brasilia
State/Province
DF
ZIP/Postal Code
700000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
34551948
Citation
Maldaner V, Coutinho J, Santana ANDC, Cipriano GFB, Oliveira MC, Carrijo MM, Lino MEM, Cahalin LP, Lima AG, Borges R, Santos DB, Silva IO, Oliveira LVF, Cipriano G Jr. Adjunctive inspiratory muscle training for patients with COVID-19 (COVIDIMT): protocol for randomised controlled double-blind trial. BMJ Open. 2021 Sep 22;11(9):e049545. doi: 10.1136/bmjopen-2021-049545.
Results Reference
derived

Learn more about this trial

Inspiratory Muscle Training in COVID-19 Patients

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