Inspiratory Muscle Strength Training in Post-Covid Syndrome

Post-COVID-19 Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06091384
• Other study ID #: IMST
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: October 2023
• Source: D'Or Institute for Research and Education
• Contact: Allan R Sales, PhD
• Phone: 55 21 996482036
• Email: allan.sales[@]idor.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Abnormalities
• COVID-19
• Physical Exercise
• Post-COVID-19 Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
Brazil	D'Or Institute of Research and Education	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle sympathetic nerve activity	Microneurography	Baseline and 6 weeks after ISMT and Sham
Primary	Endothelial function	Doppler Ultrasound	Baseline and 6 weeks after ISMT and Sham
Primary	Arterial stiffness	Applanation tonometry	Baseline and 6 weeks after ISMT and Sham
Primary	Blood pressure	Sphygmomanometry	Baseline and 6 weeks after ISMT and Sham
Primary	Exercise Capacity	Cardiopulmonary exercise testing	Baseline and 6 weeks after ISMT and Sham
Primary	Maximum inspiratory pressure	Manovacuometry	Baseline and 6 weeks after ISMT and Sham
Secondary	Oxidative stress	Blood samples	Baseline and 6 weeks after ISMT and Sham
Secondary	Nitric oxide	Blood samples	Baseline and 6 weeks after ISMT and Sham
Secondary	Inflammatory profile	Blood samples	Baseline and 6 weeks after ISMT and Sham