Inspiratory Muscle Strength Training in Post-Covid Syndrome

NCT06091384 | Unknown

• 1 other identifier: IMST
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Muscle sympathetic nerve activity

  Microneurography

  Baseline and 6 weeks after ISMT and Sham

• Endothelial function

  Doppler Ultrasound

  Baseline and 6 weeks after ISMT and Sham

• Arterial stiffness

  Applanation tonometry

  Baseline and 6 weeks after ISMT and Sham

• Blood pressure

  Sphygmomanometry

  Baseline and 6 weeks after ISMT and Sham

• Exercise Capacity

  Cardiopulmonary exercise testing

  Baseline and 6 weeks after ISMT and Sham

• Maximum inspiratory pressure

  Manovacuometry

  Baseline and 6 weeks after ISMT and Sham

Secondary Outcomes (3)

• Oxidative stress

  Baseline and 6 weeks after ISMT and Sham

• Nitric oxide

  Baseline and 6 weeks after ISMT and Sham

• Inflammatory profile

  Baseline and 6 weeks after ISMT and Sham

Study Arms (2)

Inspiratory Muscle Strength Training

EXPERIMENTAL

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

Sham- Inspiratory Muscle Training

SHAM COMPARATOR

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

Interventions

Inspiratory muscle strength training 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.

Inspiratory Muscle Strength Training; Sham- Inspiratory Muscle Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead

Study Sites (1)

D'Or Institute of Research and Education

São Paulo, 04501-000, Brazil

RECRUITING

MeSH Terms

Conditions

Cardiovascular Abnormalities; Post-Acute COVID-19 Syndrome; Motor Activity

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Allan R Sales, PhD

CONTACT

55 21 996482036; allan.sales@idor.org

Artur Sales, Bs

CONTACT

55 11 970921084

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 19, 2023
• Study Start: October 16, 2023
• Primary Completion: September 30, 2024
• Study Completion: October 31, 2024
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)