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

NCT05077241 | Unknown

• 1 other identifier: 1a2b3c4d5e6f
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Keywords

covid-19; respiratory muscle strength; spirometry

Outcome Measures

Primary Outcomes (3)

• Respiratory muscle strength

  The assessment of respiratory muscle strength will be performed by measuring the maximum respiratory pressures (Maximum Inspiratory Pressure: PImax and Maximum Expiratory Pressure: PEmax) through the use of an analog manometer (GERAR®, São Paulo, Brazil) with an operating range of ± 300 cmH2O and equipped with a mouthpiece adapter, containing an exhaust valve through an orifice of approximately 2mm in diameter to prevent the increase of intraoral pressure. For data analysis, at least three reproducible maneuvers will be used, with variability less than 20%, and the highest value will be recorded. The normality references for the calculation of maximal respiratory pressures as a function of age and gender will respect the description of the method used by Pessoa et al. (2014) for the Brazilian population.

  Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.

• Dyspnea - Medical Research Council

  Dyspnea will be assessed using the scale adapted to Portuguese by the Medical Research Council. The scale will allow the volunteer to indicate the extent to which their shortness of breath affected their mobility in daily activities. The scores range from 1 to 5, whose higher values refer to greater dyspnea, and the lower values reflect less dyspnea and will be chosen by the participant (BESTALL et al., 1999).

  Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.

• Quality of life (SF-36)

  The Medical Outcomes Study 36-Item Short Health Form Survey (SF-36) is a multidimensional questionnaire translated and validated for the Brazilian reality (CICONELLI et al., 1999; LAGUARDIA et al., 2011) that was developed to assess quality of life related to health. Scores range from 0 to 100 for each subscale, with higher scores being indicative of a better health-related quality of life (WARE; SHERBOURNE, 1992).

  Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.

Secondary Outcomes (10)

• Pulmonary function

  Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.

• Exercise tolerance

  Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.

• Functional status

  Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.

• Anxiety and depression

  Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.

• Peripheral muscle strength

  Change from baseline at 3 weeks, 6 weeks, 12 weeks and 24 weeks.

Study Arms (2)

Experimental group - inspiratory muscle training group with load

EXPERIMENTAL

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.

Device: Inspiratory muscle training

Control group - inspiratory muscle training group without load

PLACEBO COMPARATOR

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.

Device: Inspiratory muscle training

Interventions

Inspiratory muscle training 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; Experimental group - inspiratory muscle training group with load

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio Grande do Norte: lead

Study Sites (2)

Federal University of Rio Grande do Norte

Natal, Rio Grande do Norte, 59082-100, Brazil

RECRUITING

Gabriely Azevêdo

Natal, Rio Grande do Norte, 59082-100, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 37141260 DERIVED

MeSH Terms

Conditions

COVID-19

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

Study Officials

• Patrícia Angélica de Miranda Silva Nogueira.

  Universidade Federal do Rio Grande do Norte

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrícia Investigador principal

CONTACT

+55 84 33422000; idpa02@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pesquisador principal

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: October 14, 2021
• Study Start: May 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: March 1, 2024
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)