COVID-19 Acute Respiratory Distress SyndromeNCT05115383
Effects of Exercise on the Renin-angiotensin System
A study testing VO2 Max test in people with COVID-19 Acute Respiratory Distress Syndrome, run by Western University, Canada at 1 site in Canada.
Trial summary
Angiotensin converting enzyme-2 (ACE2) is part of the renin-angiotensin system (RAS), which is involved in maintaining blood flow and electrolyte balance. It has been shown in obese and hypertensive individuals that levels of another molecule Angiotensin converting enzyme (ACE) are much higher, leading to… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome
- What is being tested?
- VO2 Max test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jul 2022to 30 Apr 2023
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between the ages of 18-39
- ability to exercise to exhaustion
- ability to give informed consent
Who cannot join
- chronic consumption of recreational drugs, tobacco or alcohol
- on any prescription medication or anti-inflammatory medications
- diagnosed with any chronic conditions
- current diagnosis with COVID-19
- BMI >30
- Engage in 75-150 minutes of moderate to vigorous physical activity a week
Trial locations and contacts
1 site in 1 country.
Canada1 site
Exercise Nutrition Laboratory, Western University
London, Ontario, N6A3K7
About this study
Official title: The Effects of Exercise and Training Status on the Counter-regulatory Axis of the Renin-angiotensin-system.
Angiotensin converting enzyme-2 (ACE2) is part of the renin-angiotensin system (RAS), which is involved in maintaining blood flow and electrolyte balance. It has been shown in obese and hypertensive individuals that levels of another molecule Angiotensin converting enzyme (ACE) are much higher, leading to inflammation, fibrosis, vasoconstriction and high blood pressure. ACE2 has a protective effect from ACE, leading to anti-inflammatory, anti-fibrotic and vasodilating effects.
In animal models, it has been shown that aerobic exercise can increase levels of ACE2, while decreasing levels of ACE and offers protection to the cardiovascular system by keeping these two molecules balanced. Although the effects of exercise on the classical arm of the RAS have been studied significantly, ACE2 is a relatively new discovery and has not been studied as extensively in humans. The purpose of this research is to determine the effects of exercise training status on the RAS, specifically on ACE2 and its products.
Read the detailed description
The design of the proposed study is an intervention study, where participants are selected into either a physically active group or a sedentary group. The physically active group will be set as our control, as the physiological stress of the exercise protocol should be lower in the physically active group and limit the magnitude of the response. Both groups will be exposed to the same experimental procedure. Participants will be placed in their group based on their responses to the CSEP Get Active questionnaire. Individuals who do not accumulate less than 75 minutes of moderate to vigorous physical activity a week will be placed in the sedentary group, while those who accumulate more than 150 minutes will be placed in the active group.
Participants will be asked to avoid anti-Inflammatory medications, drugs, alcohol and smoking 48 hours prior to any of the sessions.
Participants in both groups will undergo the same testing procedure. Tests will include densitometry and a graded exercise test to measure maximum VO2 and associated parameters. Venipuncture (10 ml) will be performed before, after and 30 minutes post VO2 max test. The proposed study analysis will be conducted using a dependent groups ANOVA and Tukey's post hoc testing.
- Being tested
- VO2 Max test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VO2 Max testOther
The participant will be equipped with a vo2 mask or mouthpiece. They will get on the bike and begin with a 5 minute warmup ranging from 30-100 watts. After the warm up there will be a 15-30 watt increase every minute in the cadence that the participant is required to maintain. Once the participant has decided to stop pedalling, the participants mask will be removed to ensure they are feeling well. They will allowed to continue pedaling at their own pace for a cool down for up to two minutes.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Group | Active comparator | Individuals who are physically active for less than 75 minutes of moderate to vigorous physical activity a week will be placed in the sedentary group. Receives: Other: VO2 Max test |
| Active Group | Active comparator | Individuals who are physically active for greater than 150 minutes of moderate to vigorous physical activity will be placed in the active group. Receives: Other: VO2 Max test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mean response to an acute bout of physical activity in the components of the renin-angiotensin system
Measurements of Angiotensin(1-10) and Angiotensin(1-9) will be analyzed using ELISA kits.
Measured: measurements will be taken before, immediately post and 30 minutes post exercise.
Secondary outcomes (1)
Changes in the baseline measurements of the renin-angiotensin system between physically active and sedentary males.
Ratios of Angiotensin(1-10) and Angiotensin(1-9) will be compared between the two groups
Measured: Measurements will be made prior to commencement of exercise protocols.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start8 Jul 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115383
- Sponsor's protocol ID
- 117957
- Status last verified
- Jul 2022
- First submitted
- 3 Oct 2021
- Last updated
- 15 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Exercise and Training Status on the Counter-regulatory Axis of the Renin-angiotensin-system.
- ClinicalTrials.gov ID
- NCT05115383
- Acronym / sponsor ID
- 117957
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Study start
- 8 Jul 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 10 Nov 2021 (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.
Angiotensin converting enzyme-2 (ACE2) is part of the renin-angiotensin system (RAS), which is involved in maintaining blood flow and electrolyte balance. It has been shown in obese and hypertensive individuals that levels of another molecule Angiotensin converting enzyme (ACE) are much higher, leading to inflammation, fibrosis, vasoconstriction and high blood pressure. ACE2 has a protective effect from ACE, leading to anti-inflammatory, anti-fibrotic and vasodilating effects.
In animal models, it has been shown that aerobic exercise can increase levels of ACE2, while decreasing levels of ACE and offers protection to the cardiovascular system by keeping these two molecules balanced. Although the effects of exercise on the classical arm of the RAS have been studied significantly, ACE2 is a relatively new discovery and has not been studied as extensively in humans. The purpose of this research is to determine the effects of exercise training status on the RAS, specifically on ACE2 and its products.
Detailed description
The design of the proposed study is an intervention study, where participants are selected into either a physically active group or a sedentary group. The physically active group will be set as our control, as the physiological stress of the exercise protocol should be lower in the physically active group and limit the magnitude of the response. Both groups will be exposed to the same experimental procedure. Participants will be placed in their group based on their responses to the CSEP Get Active questionnaire. Individuals who do not accumulate less than 75 minutes of moderate to vigorous physical activity a week will be placed in the sedentary group, while those who accumulate more than 150 minutes will be placed in the active group.
Participants will be asked to avoid anti-Inflammatory medications, drugs, alcohol and smoking 48 hours prior to any of the sessions.
Participants in both groups will undergo the same testing procedure. Tests will include densitometry and a graded exercise test to measure maximum VO2 and associated parameters. Venipuncture (10 ml) will be performed before, after and 30 minutes post VO2 max test. The proposed study analysis will be conducted using a dependent groups ANOVA and Tukey's post hoc testing.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary Group | Active comparator | Other: VO2 Max testIndividuals who are physically active for less than 75 minutes of moderate to vigorous physical activity a week will be placed in the sedentary group. |
| Active Group | Active comparator | Other: VO2 Max testIndividuals who are physically active for greater than 150 minutes of moderate to vigorous physical activity will be placed in the active group. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- between the ages of 18-39
- ability to exercise to exhaustion
- ability to give informed consent
Key exclusion criteria (6 listed)
- chronic consumption of recreational drugs, tobacco or alcohol
- on any prescription medication or anti-inflammatory medications
- diagnosed with any chronic conditions
- current diagnosis with COVID-19
- BMI >30
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 |
|---|---|---|
| VO2 Max testThe participant will be equipped with a vo2 mask or mouthpiece. They will get on the bike and begin with a 5 minute warmup ranging from 30-100 watts. After the warm up there will be a 15-30 watt increase every minute in the cadence that the participant is required to maintain. Once the participant has decided to stop pedalling, the participants mask will be removed to ensure they are feeling well. They will allowed to continue pedaling at their own pace for a cool down for up to two minutes. | Other | Active Group, Sedentary Group |
Primary outcome
Change in the mean response to an acute bout of physical activity in the components of the renin-angiotensin system
Time frame: measurements will be taken before, immediately post and 30 minutes post exercise.
Measurements of Angiotensin(1-10) and Angiotensin(1-9) will be analyzed using ELISA kits.
1 secondary outcome
Changes in the baseline measurements of the renin-angiotensin system between physically active and sedentary males.
Time frame: Measurements will be made prior to commencement of exercise protocols.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VO2 Max test in people with COVID-19 Acute Respiratory Distress Syndrome, run by Western University, Canada at 1 site in Canada.
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 3 inclusion and 6 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 15 Jul 2022. 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 Canada. 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the mean response to an acute bout of physical activity in the components of the renin-angiotensin system (time frame: measurements will be taken before, immediately post and 30 minutes post exercise.). 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 15 Jul 2022.