Inspiratory Muscle Strength Training in Post-Covid Syndrome

• Sponsor: D'Or Institute for Research and Education (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06091384
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.5
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Abnormalities; Post-COVID-19 Syndrome; Physical Exercise	Other: Inspiratory muscle strength training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 16, 2023
• Anticipated Primary Completion Date: Sep 30, 2024
• Anticipated Study Completion Date: Oct 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Muscle sympathetic nerve activity [Baseline and 6 weeks after ISMT and Sham]

   Microneurography

2. Endothelial function [Baseline and 6 weeks after ISMT and Sham]

   Doppler Ultrasound

3. Arterial stiffness [Baseline and 6 weeks after ISMT and Sham]

   Applanation tonometry

4. Blood pressure [Baseline and 6 weeks after ISMT and Sham]

   Sphygmomanometry

5. Exercise Capacity [Baseline and 6 weeks after ISMT and Sham]

   Cardiopulmonary exercise testing

6. Maximum inspiratory pressure [Baseline and 6 weeks after ISMT and Sham]

   Manovacuometry

Secondary Outcome Measures

1. Oxidative stress [Baseline and 6 weeks after ISMT and Sham]

   Blood samples

2. Nitric oxide [Baseline and 6 weeks after ISMT and Sham]

   Blood samples

3. Inflammatory profile [Baseline and 6 weeks after ISMT and Sham]

   Blood samples

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	D'Or Institute of Research and Education	São Paulo		Brazil	04501-000

Sponsors and Collaborators

• D'Or Institute for Research and Education

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: D'Or Institute for Research and Education
• ClinicalTrials.gov Identifier: NCT06091384
• Other Study ID Numbers: IMST
• First Posted: Oct 19, 2023
• Last Update Posted: Oct 19, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Cardiovascular Abnormalities; Syndrome

Study Results

No Results Posted as of Oct 19, 2023