Efficacy of Home Inspiratory Muscle Training in Post-covid-19 Patients: a Randomized Clinical Trial

NCT ID: NCT05077241

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-03-31

Brief Summary

INTRODUCTION: Coronavirus 2019 disease (COVID-19), caused by the Severe Acute Respiratory Syndrome (SRAG) of coronavirus 2 (SARS-CoV-2) surpassed the global number of 119,603,761 cases, with more than 2,649,722 reported deaths . There is sufficient evidence for a possible post-covid-19 syndrome, designating sequelae with persistent symptoms. Respiratory muscle training improves respiratory muscle strength, exercise capacity, diaphragm muscle thickness, and dyspnea in various patient populations, especially in those with the greatest reduction in basal respiratory muscle strength. OBJECTIVE: To evaluate the effectiveness of a home inspiratory muscle training protocol in improving respiratory muscle strength, dyspnea and quality of life in post-Covid-19 patients. MATERIALS AND METHODS: This is a clinical, controlled, randomized and blind trial, which will be carried out at the Institute of Tropical Medicine of the Federal University of Rio Grande do Norte. The sample size will be performed using GPower software version 3.1.9.2 (Kiel, Germany) for Windows and will be established after conducting a pilot study with 5 participants in each group (total of 10 subjects) for a hypothetical two-way ANOVA test, using the main variable the Maximum Inspiratory Pressure (PImax.). The subjects included in the research will undergo three evaluation moments: Pre-training (Initial), Post-training (6 weeks) and Retention Test (24 weeks) for clinical evaluation form, anthropometric measures, respiratory muscle strength, volumes and capacities pulmonary symptoms, dyspnea, perceived exertion and fatigue, handgrip strength, six-minute walk test, anxiety and depression, post-covid functional status. After the initial assessment, all volunteers will receive a POWERbreathe® device (POWERbreathe®, HaB Ltd, Southam, UK) to carry out the training. EXPECTED RESULTS: provide a safe, effective and easy-to-perform treatment for post-covid-19 patients.

Detailed Description

The subjects included in the research will go through three evaluation moments: Pre-training (Initial), Post-training (3 and 6 weeks) and Retention Test (12 and 24 weeks).

After recruitment, participants will be invited to attend the Institute of Tropical Medicine to carry out an initial assessment by an evaluator previously trained and blinded to the intervention allocation group and will include anamnesis and physical examination, with measurement of vital signs, anthropometric measurements, assessment of lung volumes, respiratory muscle strength, peripheral muscle strength, quality of life, anxiety and depression, functional status and the 6-minute walk test.

After the initial evaluation, all volunteers will receive a POWERbreathe® device (POWERbreathe®, HaB Ltd, Southam, UK), to carry out the training, and will be individually instructed on how to use it and on the performance of the protocol. They will conduct an experimental session to familiarize themselves with the device that will not be considered for review. Every three days, volunteers will receive a phone call from researcher 2, who will not participate in the assessment, to confirm whether the exercise with the POWERbreathe® was being performed properly at the frequency and load set and if there were any doubts regarding the protocol. At the end of each week, participants will receive a video call from researcher 2 to adjust the device according to the weekly load progression of G1.

All evaluation moments (pre-training, post-training and retention test) will be performed by a single evaluator (Evaluator 1) - who will not know which group the subject will be allocated to - and recorded in the evaluation form developed for the project. A second researcher (Evaluator 2) will be responsible for applying the training protocols to the subjects.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group - inspiratory muscle training group with load

Experimental group: Inspiratory muscle training with POWERbreathe® (POWERbreathe®, HaB Ltd, Southam, UK) with 30% of Pimax. with weekly load increment of 10% of the Pimax value. initial. The sessions will consist of 30 repetitions, twice a day, one in the morning and one in the afternoon, 7 consecutive days a week, for 6 weeks. Individuals will be instructed to perform a rapid contraction of the inspiratory muscles and sustain it for 2 seconds in each maneuver, and will have the possibility to rest every 3 repetitions of the TMI, for 30 seconds, to avoid muscle fatigue or any other complication.

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: DEVICE

Individuals will be instructed to perform a rapid contraction of the inspiratory muscles against a load and sustain it for 2 seconds in each maneuver.

Control group - inspiratory muscle training group without load

Subjects will use a IMT POWERbreathe® (POWERbreathe®, HaB Ltd, Southam, UK) device without any load and will receive the same guidelines as experimental group (The sessions will consist of 30 repetitions, twice a day, one in the morning and one in the afternoon, 7 consecutive days a week, for 6 weeks. Individuals will be instructed to perform a rapid contraction of the inspiratory muscles and sustain it for 2 seconds in each maneuver, and will have the possibility to rest every 3 repetitions of the TMI, for 30 seconds, to avoid muscle fatigue or any other complication). At the end of the research, the control group will have the right to experimental treatment with the IMT protocol, if this is effective.

Group Type: PLACEBO_COMPARATOR

Inspiratory muscle training

Intervention Type: DEVICE

Individuals will be instructed to perform a rapid contraction of the inspiratory muscles against a load and sustain it for 2 seconds in each maneuver.

Interventions

Inspiratory muscle training

Individuals will be instructed to perform a rapid contraction of the inspiratory muscles against a load and sustain it for 2 seconds in each maneuver.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• subjects of both sexes, sedentary, within two months of a diagnosis of COVID-19 confirmed by RT-PCR, aged over 18 years and without any underlying respiratory disease, with adequate cognitive status defined through the Mini Mental State Examination and reduced muscle strength respiratory, defined through the assessment of the maximum inspiratory pressure.

Exclusion Criteria

• subjects who present any condition that makes it impossible to carry out the assessments and protocols, complications that justify the interruption of data collection, such as syncope, severe chest pain, coughing up blood, those who request withdrawal from the study and who present adverse effects such as hospitalization by exacerbation of the clinical picture.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal do Rio Grande do Norte

OTHER

Sponsor Role: lead

Responsible Party

Patri-cia Angelica de Miranda Silva Nogueira

Pesquisador principal

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Patrícia Angélica de Miranda Silva Nogueira.

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio Grande do Norte

Locations

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, Brazil

Site Status: RECRUITING

Gabriely Azevêdo

Natal, Rio Grande do Norte, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Patrícia Investigador principal

Role: CONTACT

idpa02@hotmail.com

+55 84 33422000

Facility Contacts

Gabriely Azevêdo

Role: primary

gabrielyazevedo.ga@gmail.com

84999390004

Patrícia Nogueira

Role: backup

Gabriely Azevêdo Silva

Role: primary

gabrielyazevedo.ga@gmail.com

84999390004

Patrícia Nogueira

Role: backup

References

Goncalo Silva GA, Nogueira IDB, da Silva Chiappa GR, Nogueira PAMS. Efficacy of home-based inspiratory muscle training in patients post-covid-19: Protocol for a randomized clinical trial. PLoS One. 2023 May 4;18(5):e0279310. doi: 10.1371/journal.pone.0279310. eCollection 2023.

Reference Type: DERIVED

PMID: 37141260 (View on PubMed)

Other Identifiers

1a2b3c4d5e6f

Identifier Type: -

Identifier Source: org_study_id