Inspiratory Muscle Strength Training in Post-Covid Syndrome

NCT ID: NCT06091384

Last Updated: 2023-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-16
• Study Completion Date: 2024-10-31

Brief 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.

Conditions

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Inspiratory muscle strength training

Intervention Type: OTHER

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- 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.

Group Type: SHAM_COMPARATOR

Inspiratory muscle strength training

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

D'Or Institute for Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

D'Or Institute of Research and Education

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Allan R Sales, PhD

Role: CONTACT

allan.sales@idor.org

55 21 996482036

Artur Sales, Bs

Role: CONTACT

55 11 970921084

Facility Contacts

Allan R Kluser Sales, PhD

Role: primary

allan.sales@idor.org

55+21996482036

Other Identifiers

IMST

Identifier Type: -

Identifier Source: org_study_id