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Inspiratory Muscle Strength Training in Post-Covid Syndrome

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Inspiratory muscle strength training
Sponsored by
D'Or Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Abnormalities

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • D'Or Institute of Research and EducationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Inspiratory Muscle Strength Training

Sham- Inspiratory Muscle Training

Arm 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.

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

Outcomes

Primary Outcome Measures

Muscle sympathetic nerve activity
Microneurography
Endothelial function
Doppler Ultrasound
Arterial stiffness
Applanation tonometry
Blood pressure
Sphygmomanometry
Exercise Capacity
Cardiopulmonary exercise testing
Maximum inspiratory pressure
Manovacuometry

Secondary Outcome Measures

Oxidative stress
Blood samples
Nitric oxide
Blood samples
Inflammatory profile
Blood samples

Full Information

First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
D'Or Institute for Research and Education
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1. Study Identification

Unique Protocol Identification Number
NCT06091384
Brief Title
Inspiratory Muscle Strength Training in Post-Covid Syndrome
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
D'Or Institute for Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Abnormalities, Post-COVID-19 Syndrome, Physical Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory Muscle Strength Training
Arm Type
Experimental
Arm 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.
Arm Title
Sham- Inspiratory Muscle Training
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Inspiratory muscle strength training
Intervention Description
Using a handheld device, participants will perform 30 breaths per day at 75% of maximal inspiratory pressure, six days a week, during 6 weeks.
Primary Outcome Measure Information:
Title
Muscle sympathetic nerve activity
Description
Microneurography
Time Frame
Baseline and 6 weeks after ISMT and Sham
Title
Endothelial function
Description
Doppler Ultrasound
Time Frame
Baseline and 6 weeks after ISMT and Sham
Title
Arterial stiffness
Description
Applanation tonometry
Time Frame
Baseline and 6 weeks after ISMT and Sham
Title
Blood pressure
Description
Sphygmomanometry
Time Frame
Baseline and 6 weeks after ISMT and Sham
Title
Exercise Capacity
Description
Cardiopulmonary exercise testing
Time Frame
Baseline and 6 weeks after ISMT and Sham
Title
Maximum inspiratory pressure
Description
Manovacuometry
Time Frame
Baseline and 6 weeks after ISMT and Sham
Secondary Outcome Measure Information:
Title
Oxidative stress
Description
Blood samples
Time Frame
Baseline and 6 weeks after ISMT and Sham
Title
Nitric oxide
Description
Blood samples
Time Frame
Baseline and 6 weeks after ISMT and Sham
Title
Inflammatory profile
Description
Blood samples
Time Frame
Baseline and 6 weeks after ISMT and Sham

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Allan R Sales, PhD
Phone
55 21 996482036
Email
allan.sales@idor.org
First Name & Middle Initial & Last Name or Official Title & Degree
Artur Sales, Bs
Phone
55 11 970921084
Facility Information:
Facility Name
D'Or Institute of Research and Education
City
São Paulo
ZIP/Postal Code
04501-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan R Kluser Sales, PhD
Phone
55+21996482036
Email
allan.sales@idor.org
First Name & Middle Initial & Last Name & Degree
Allan Kluser Sales, Phd

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Inspiratory Muscle Strength Training in Post-Covid Syndrome

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