Cardiovascular AbnormalitiesNCT06091384
Inspiratory Muscle Strength Training in Post-Covid Syndrome
A study testing Inspiratory muscle strength training in people with Cardiovascular Abnormalities and Post-COVID-19 Syndrome, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Abnormalities, Post-COVID-19 Syndrome, Physical Exercise
- What is being tested?
- Inspiratory muscle strength training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Oct 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Artur Sales, Bs contact
Brazil1 site, 1 recruiting
- Recruiting
D'Or Institute of Research and Education
São Paulo, 04501-000
Allan R Kluser Sales, PhD, 55+21996482036, allan.sales@idor.org
Allan Kluser Sales, Phd
About this study
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
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.
- Being tested
- Inspiratory muscle strength training
- Medical subject headings
- Cardiovascular Abnormalities, Post-Acute COVID-19 Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle strength trainingOther
Using a handheld device, participants will perform 30 breaths per day at 75% of maximal inspiratory pressure, six days a week, during 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Inspiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle sympathetic nerve activity
Microneurography
Measured: Baseline and 6 weeks after ISMT and Sham
Endothelial function
Doppler Ultrasound
Measured: Baseline and 6 weeks after ISMT and Sham
Arterial stiffness
Applanation tonometry
Measured: Baseline and 6 weeks after ISMT and Sham
Blood pressure
Sphygmomanometry
Measured: Baseline and 6 weeks after ISMT and Sham
Exercise Capacity
Cardiopulmonary exercise testing
Measured: Baseline and 6 weeks after ISMT and Sham
Maximum inspiratory pressure
Manovacuometry
Measured: Baseline and 6 weeks after ISMT and Sham
Secondary outcomes (3)
Oxidative stress
Blood samples
Measured: Baseline and 6 weeks after ISMT and Sham
Nitric oxide
Blood samples
Measured: Baseline and 6 weeks after ISMT and Sham
Inflammatory profile
Blood samples
Measured: Baseline and 6 weeks after ISMT and Sham
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start16 Oct 2023
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular AbnormalitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06091384
- Sponsor's protocol ID
- IMST
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06091384
- Acronym / sponsor ID
- IMST
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Strength Training | Experimental | Other: Inspiratory muscle strength trainingUsing a handheld device, participants will perform 30 breaths a day at 75% of maximal inspiratory pressure, six days a week, for 6 weeks. |
| Sham- Inspiratory Muscle Training | Sham comparator | Other: Inspiratory muscle strength trainingUsing a handheld device, participants will perform 30 breaths a day at 15% of maximal inspiratory pressure, six days a week, for 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle strength trainingUsing a handheld device, participants will perform 30 breaths per day at 75% of maximal inspiratory pressure, six days a week, during 6 weeks. | Other | Inspiratory Muscle Strength Training, Sham- Inspiratory Muscle Training |
Primary outcome
Muscle sympathetic nerve activity
Time frame: Baseline and 6 weeks after ISMT and Sham
Microneurography
Endothelial function
Time frame: Baseline and 6 weeks after ISMT and Sham
Doppler Ultrasound
Arterial stiffness
Time frame: Baseline and 6 weeks after ISMT and Sham
Applanation tonometry
Blood pressure
Time frame: Baseline and 6 weeks after ISMT and Sham
Sphygmomanometry
Exercise Capacity
Time frame: Baseline and 6 weeks after ISMT and Sham
Cardiopulmonary exercise testing
Maximum inspiratory pressure
Time frame: Baseline and 6 weeks after ISMT and Sham
Manovacuometry
3 secondary outcomes
Oxidative stress
Time frame: Baseline and 6 weeks after ISMT and Sham
Nitric oxide
Time frame: Baseline and 6 weeks after ISMT and Sham
Inflammatory profile
Time frame: Baseline and 6 weeks after ISMT and Sham
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Artur Sales, Bs contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle strength training in people with Cardiovascular Abnormalities and Post-COVID-19 Syndrome, run by D'Or Institute for Research and Education at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Allan R Sales, PhD (55 21 996482036, allan.sales@idor.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle sympathetic nerve activity (time frame: Baseline and 6 weeks after ISMT and Sham). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.