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Covid19ADDIMTCOVIDNCT04595097

Inspiratory Muscle Training in COVID-19 Patients

A study testing inspiratory muscle traiing in people with Covid19 and Exercise, run by Escola Superior de Ciencias da Saude at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19, Exercise
What is being tested?
inspiratory muscle traiing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteBrazil
Study dates
1 Mar 2021to 31 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Secretaria de Saúde do Distrito Federal

    Brasília, Federal District, 700000

Other trials in Brazil

About this study

Official title: Adjunctive Inspiratory Muscle Training for Patients With COVID-19

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.

Conditions
Covid19, Exercise
Being tested
inspiratory muscle traiing
Keywords
respiratory function tests, inspiratory muscle training
Medical subject headings
COVID-19, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inspiratory muscle traiingDevice

    Also called tapered flow resistive loading

    The patients are encouraged to inhale against a load to increase the inspiratory muscle strength and endurance

Study groups in NCT04595097
Study groupRoleWhat they receive
Intervention GroupExperimentalThe 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.
Receives: Device: inspiratory muscle traiing
Control groupActive comparatorThe 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.
Receives: Device: inspiratory muscle traiing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: change from baseline in Peak VO2, VE/VCO2 slope and VAT at 8 weeks and 6 months

Secondary outcomes (14)

  1. 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

    Measured: change from baseline in FSS score at 8 weeks and 6 months

  2. 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.

    Measured: Change from baseline in HADS score at 8 weeks and 6 months

  3. 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.

    Measured: 6 months

  4. 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

    Measured: change from baseline in EQ-5D score at 8 weeks and 6 months

  5. 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).

    Measured: change from baseline in FEV1 and FVC in Liters at 8 weeks and 6 months.

  6. 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.

    Measured: change from baseline in mMRC score at 8 weeks and 6 months

  7. Respiratory muscle strength

    Pulmonary function test with Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) measurements

    Measured: change from baseline in MIP and MEP at 8 weeks and 6 months

  8. Postural Control

    postural control assessed by stabilometry test

    Measured: change from baseline in Postural stability test and fall risk test at 8 weeks

  9. isometric knee extension strength

    peripheral muscle stregnth assessed by isometric load dynamometer

    Measured: change from baseline in Nm at 8 weeks

  10. displacement

    outcomes assessed by baropodometry

    Measured: change from baseline in CM2 at 8 weeks

  11. trajectory

    outcome assessed by baropodometry

    Measured: change from baseline in CM2 at 8 weeks

  12. isometric knee flexion strength

    peripheral muscle stregnth assessed by isometric load dynamometer

    Measured: change from baseline in Nm at 8 weeks

  13. dynamic balance

    dynamic balance assessed by Mini-BEST testing

    Measured: change from baseline in Total score at 8 weeks

  14. Sit to Stand Test

    exercise capacity assessed by Sit to Stand test

    Measured: change from baseline in repetitions at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start1 Mar 2021
  3. Primary completion30 Apr 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04595097
Sponsor's protocol ID
CNPQ092020
Acronym
ADDIMTCOVID
Status last verified
Sep 2023
First submitted
19 Oct 2020
Last updated
15 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34551948

Questions about this trial

What is this clinical trial studying?

A study testing inspiratory muscle traiing in people with Covid19 and Exercise, run by Escola Superior de Ciencias da Saude at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiopulmonary Exercise Testing Measurements (time frame: change from baseline in Peak VO2, VE/VCO2 slope and VAT at 8 weeks and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04595097, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.

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