Essential HypertensionNCT05092672
Physical Activity, Air Pollution, and High Blood Pressure
A study testing Exercise in people with Essential Hypertension, run by University of British Columbia at 1 site in Canada.
Trial summary
The investigators are investigating the effects of traffic-related air pollution (TRAP) on the cardiovascular and pulmonary response to exercise in patients with hypertension using a real world randomized, crossover study design. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2021to 1 Aug 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 40-70 years of age
- Previously diagnosed with elevated blood pressure or hypertension by a physician
Who cannot join
- Current or ex-smokers (abstinent for less than one year)
- Lives with an individual who currently smokes cigarettes, e-cigarettes (i.e., vaping), or cannabis
- Hormone replacement therapy use
- Currently on beta-blocker or angiotensin receptor blocker (ARB) therapy
- Currently using over the counter drugs or supplements that may alter cardiovascular measures (as per the principal investigator's discretion)
- Prior diagnosis of any other existing cardiovascular or pulmonary diseases and/or conditions (other than hypertension)
- Musculoskeletal injury or lower limb limitation preventing safe engagement in moderate-intensity exercise
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Impact of Traffic-related Air Pollution on the Cardiovascular and Pulmonary Response to Physical Activity in Patients With Hypertension
The investigators are investigating the effects of traffic-related air pollution (TRAP) on the cardiovascular and pulmonary response to exercise in patients with hypertension using a real world randomized, crossover study design. Participants will be exposed to 2 conditions: a low TRAP environment and a high TRAP environment. Each exposure will consist of 30 min of moderate-intensity exercise. Cardiovascular and pulmonary health outcomes will be measured before, during, and up to 24 hours following exposures. A minimum washout period of 1 week will be used to minimize carryover effects.
- Conditions
- Essential Hypertension
- Being tested
- Exercise
- Keywords
- Traffic-related air pollution, Physical activity, Exercise, Blood pressure, Heart rate variability, Arterial stiffness, Microvascular responsiveness, Muscle oxygen saturation, Lung function
- Medical subject headings
- Essential Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants will engage in moderate-intensity (40-59% HRR) exercise for 30 min
| Study group | Role | What they receive |
|---|---|---|
| High traffic-related air pollution first | Experimental | Participants will exercise in an environment with high levels of traffic-related air pollution first. Afterwards, participants will complete the same exercise in an environment with low levels of traffic-related air pollution. Receives: Behavioral: Exercise |
| Low traffic-related air pollution | Experimental | Participants will exercise in an environment with low levels of traffic-related air pollution first. Afterwards, participants will complete the same exercise in an environment with high levels of traffic-related air pollution. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Blood Pressure at 2 Hours Post-Exposure
MAP, SBP, and DBP
Measured: Baseline and 2 hours post-exposure
Secondary outcomes (9)
24-Hour Blood Pressure
MAP, SBP, and DBP
Measured: 24 hours post-exposure
Heart Rate Variability
Indices of heart rate variability
Measured: Baseline and up to 24 hours post-exposure
Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure
Pulse wave velocity and augmentation index
Measured: Baseline and 2 hours post-exposure
Change from Baseline Microvascular Responsiveness at 2 Hours Post-Exposure
Microvascular responsiveness (measured by near-infrared spectroscopy)
Measured: Baseline and 2 hours post-exposure
Muscle Oxygen Saturation
Muscle oxygen saturation (measured by near-infrared spectroscopy)
Measured: Continuously throughout the 30 minute exercise bouts (during exposure)
Change from Baseline FEV1 and FVC at 2 Hours Post-Exposure
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) measured by spirometry (in L)
Measured: Baseline and 2 hours post-exposure
Change from Baseline FEV1/FVC at 2 Hours Post-Exposure
FEV1/FVC ratio measured by spirometry
Measured: Baseline and 2 hours post-exposure
Change from Baseline FEF25-75 and PEFR at 2 Hours Post-Exposure
Forced expiratory flow at 25-75% of forced vital capacity (FEF25-75) and peak expiratory flow rate (PEFR) measured by spirometry (in L/s)
Measured: Baseline and 2 hours post-exposure
Severity of Symptoms
Severity of respiratory symptoms (e.g., dyspnea, cough, wheeze, chest tightness) and headache on a 0-5 scale
Measured: Baseline and 2 hours post-exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start15 Nov 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Koehle, University of British Columbia
- Investigators
- Michael Koehle, MD, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092672
- Sponsor's protocol ID
- H21-01487
- Status last verified
- Aug 2024
- First submitted
- 28 Sep 2021
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Traffic-related Air Pollution on the Cardiovascular and Pulmonary Response to Physical Activity in Patients With Hypertension
- ClinicalTrials.gov ID
- NCT05092672
- Acronym / sponsor ID
- H21-01487
- Conditions
- Essential Hypertension
- Keywords
- Traffic-related air pollution, Physical activity, Exercise, Blood pressure, Heart rate variability, Arterial stiffness, Microvascular responsiveness, Muscle oxygen saturation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 25 Oct 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.
The investigators are investigating the effects of traffic-related air pollution (TRAP) on the cardiovascular and pulmonary response to exercise in patients with hypertension using a real world randomized, crossover study design. Participants will be exposed to 2 conditions: a low TRAP environment and a high TRAP environment. Each exposure will consist of 30 min of moderate-intensity exercise. Cardiovascular and pulmonary health outcomes will be measured before, during, and up to 24 hours following exposures. A minimum washout period of 1 week will be used to minimize carryover effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| High traffic-related air pollution first | Experimental | Behavioral: ExerciseParticipants will exercise in an environment with high levels of traffic-related air pollution first. Afterwards, participants will complete the same exercise in an environment with low levels of traffic-related air pollution. |
| Low traffic-related air pollution | Experimental | Behavioral: ExerciseParticipants will exercise in an environment with low levels of traffic-related air pollution first. Afterwards, participants will complete the same exercise in an environment with high levels of traffic-related air pollution. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 40-70 years of age
- Previously diagnosed with elevated blood pressure or hypertension by a physician
Key exclusion criteria (7 listed)
- Current or ex-smokers (abstinent for less than one year)
- Lives with an individual who currently smokes cigarettes, e-cigarettes (i.e., vaping), or cannabis
- Hormone replacement therapy use
- Currently on beta-blocker or angiotensin receptor blocker (ARB) therapy
- Currently using over the counter drugs or supplements that may alter cardiovascular measures (as per the principal investigator's discretion)
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 |
|---|---|---|
| ExerciseParticipants will engage in moderate-intensity (40-59% HRR) exercise for 30 min | Behavioural | High traffic-related air pollution first, Low traffic-related air pollution |
Primary outcome
Change from Baseline Blood Pressure at 2 Hours Post-Exposure
Time frame: Baseline and 2 hours post-exposure
MAP, SBP, and DBP
9 secondary outcomes
24-Hour Blood Pressure
Time frame: 24 hours post-exposure
Heart Rate Variability
Time frame: Baseline and up to 24 hours post-exposure
Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure
Time frame: Baseline and 2 hours post-exposure
Change from Baseline Microvascular Responsiveness at 2 Hours Post-Exposure
Time frame: Baseline and 2 hours post-exposure
Muscle Oxygen Saturation
Time frame: Continuously throughout the 30 minute exercise bouts (during exposure)
Change from Baseline FEV1 and FVC at 2 Hours Post-Exposure
Time frame: Baseline and 2 hours post-exposure
Change from Baseline FEV1/FVC at 2 Hours Post-Exposure
Time frame: Baseline and 2 hours post-exposure
Change from Baseline FEF25-75 and PEFR at 2 Hours Post-Exposure
Time frame: Baseline and 2 hours post-exposure
Severity of Symptoms
Time frame: Baseline and 2 hours post-exposure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- 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.
Michael Koehle, MD, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Essential Hypertension, run by University of British Columbia 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 12 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 from Baseline Blood Pressure at 2 Hours Post-Exposure (time frame: Baseline and 2 hours post-exposure). 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 12 Aug 2024.