Effects of Exercise on the Renin-angiotensin System
Primary Purpose
COVID-19 Acute Respiratory Distress Syndrome
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
VO2 Max test
Sponsored by
About this trial
This is an interventional basic science trial for COVID-19 Acute Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- between the ages of 18-39
- ability to exercise to exhaustion
- ability to give informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Exercise Nutrition Laboratory, Western University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Sedentary Group
Active Group
Arm Description
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.
Individuals who are physically active for greater than 150 minutes of moderate to vigorous physical activity will be placed in the active group.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05115383
First Posted
October 3, 2021
Last Updated
July 12, 2022
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT05115383
Brief Title
Effects of Exercise on the Renin-angiotensin System
Official Title
The Effects of Exercise and Training Status on the Counter-regulatory Axis of the Renin-angiotensin-system.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
July 8, 2022 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Acute Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sedentary Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active Group
Arm Type
Active Comparator
Arm Description
Individuals who are physically active for greater than 150 minutes of moderate to vigorous physical activity will be placed in the active group.
Intervention Type
Other
Intervention Name(s)
VO2 Max test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the mean response to an acute bout of physical activity in the components of the renin-angiotensin system
Description
Measurements of Angiotensin(1-10) and Angiotensin(1-9) will be analyzed using ELISA kits.
Time Frame
measurements will be taken before, immediately post and 30 minutes post exercise.
Secondary Outcome Measure Information:
Title
Changes in the baseline measurements of the renin-angiotensin system between physically active and sedentary males.
Description
Ratios of Angiotensin(1-10) and Angiotensin(1-9) will be compared between the two groups
Time Frame
Measurements will be made prior to commencement of exercise protocols.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
between the ages of 18-39
ability to exercise to exhaustion
ability to give informed consent
Exclusion Criteria:
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
Facility Information:
Facility Name
Exercise Nutrition Laboratory, Western University
City
London
State/Province
Ontario
ZIP/Postal Code
N6A3K7
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effects of Exercise on the Renin-angiotensin System
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