Inspiratory Muscle Strength Training in Post-Covid Syndrome

D'Or Institute for Research and Education

Status: Enrolling

Conditions: Cardiovascular Abnormalities; Post-COVID-19 Syndrome; Physical Exercise

Treatments: Other: Inspiratory muscle strength training

Study type: Interventional

Funder types: Other

Identifiers

NCT06091384

IMST

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Inspiratory Muscle Strength Training

Experimental group

Description:

Using a handheld device, participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, six days a week, for 6 weeks.

Treatment:

Other: Inspiratory muscle strength training

Sham- Inspiratory Muscle Training

Sham Comparator group

Description:

Using a handheld device, participants will perform 30 breaths a day at 15% of maximal inspiratory pressure, six days a week, for 6 weeks.

Treatment:

Other: Inspiratory muscle strength training