Inspiratory Muscle Strength Training in Post-Covid Syndrome

The Effects of Based-home High-resistance Inspiratory Muscle Training on Neurovascular Control, Blood Pressure, and Exercise Capacity in Patients With Post-COVID-19 Syndrome

Patients with post-Covid-19 syndrome are at high risk of developing cardiovascular diseases 12 months after acute infection of COVID-19. We recently revealed that these patients have elevated muscular sympathetic nerve activity (MSNA), vascular dysfunction, impaired cardiac diastolic function, and reduced functional capacity. Considering that these outcomes are independent predictors of cardiovascular mortality, it is urgent to restore the cardiovascular health of these patients. High resistance inspiratory muscle strength training (IMST) at 75% of pressure inspiratory (PImax) performed at home (5 min/session, 5-7 times/week per 6 weeks) reduces the MSNA, improves the endothelial function and lowers blood pressure in different populations. Based on these findings, IMST (75% PImax) is an excellent therapeutic option for patients with post-COVID-19 syndrome. Therefore, the aim of the present proposal is to test whether IMST (75% PImax) reduces sympathetic activity, improves vascular function, and restores cardiac function, evoking an increase in functional capacity in patients with post-COVID-19 syndrome. To test these hypotheses we will conduct a randomized, double-blind, sham-controlled clinical trial to test these hypotheses.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Abnormalities; Post-COVID-19 Syndrome; Physical Exercise
• Intervention / Treatment: Other: Inspiratory muscle strength training

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allan R Sales, PhD; Phone Number: 55 21 996482036; Email: allan.sales@idor.org
• Study Contact Backup: Name: Artur Sales, Bs; Phone Number: 55 11 970921084

Study Locations

• Brazil
  • São Paulo, Brazil, 04501-000
    • Recruiting
    • D'Or Institute of Research and Education
    • Contact: Allan R Kluser Sales, PhD; Phone Number: 55+21996482036; Email: allan.sales@idor.org
    • Principal Investigator: Allan Kluser Sales, Phd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Post-COVID-19 syndrome
• Have been diagnosed with COVID-19 by RT-PCR
• Have oxygen saturation ≤ 93% in room air during the acute phase of the COVID-19
• Have received oxygen supply from any device during the acute phase of the COVID-19
• Hospitalization to treat the Covid-19
• Participants in cardiopulmonary rehabilitation or physical conditioning programs

Exclusion Criteria:

• Pregnant
• History of chronic obstructive pulmonary disease or dependence on oxygen support
• History of cardiovascular and renal diseases and cancer prior to the COVID-19 diagnosis
• Difficulties in moving to the laboratory for assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory Muscle Strength Training; Using a handheld device, participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, six days a week, for 6 weeks.	Other: Inspiratory muscle strength training; Using a handheld device, participants will perform 30 breaths per day at 75% of maximal inspiratory pressure, six days a week, during 6 weeks.
Sham Comparator: Sham- Inspiratory Muscle Training; Using a handheld device, participants will perform 30 breaths a day at 15% of maximal inspiratory pressure, six days a week, for 6 weeks.	Other: Inspiratory muscle strength training; Using a handheld device, participants will perform 30 breaths per day at 75% of maximal inspiratory pressure, six days a week, during 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle sympathetic nerve activity	Microneurography	Baseline and 6 weeks after ISMT and Sham
Endothelial function	Doppler Ultrasound	Baseline and 6 weeks after ISMT and Sham
Arterial stiffness	Applanation tonometry	Baseline and 6 weeks after ISMT and Sham
Blood pressure	Sphygmomanometry	Baseline and 6 weeks after ISMT and Sham
Exercise Capacity	Cardiopulmonary exercise testing	Baseline and 6 weeks after ISMT and Sham
Maximum inspiratory pressure	Manovacuometry	Baseline and 6 weeks after ISMT and Sham

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxidative stress	Blood samples	Baseline and 6 weeks after ISMT and Sham
Nitric oxide	Blood samples	Baseline and 6 weeks after ISMT and Sham
Inflammatory profile	Blood samples	Baseline and 6 weeks after ISMT and Sham

Collaborators and Investigators

• Sponsor: D'Or Institute for Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Estimated): September 30, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: October 17, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Congenital Abnormalities; COVID-19; Syndrome; Cardiovascular Abnormalities
• Other Study ID Numbers: IMST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No