Clinical trial NCT05092672: Physical Activity, Air Pollution, and High Blood Pressure
Official title: Impact of Traffic-related Air Pollution on the Cardiovascular and Pulmonary Response to Physical Activity in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Hypertension
Keywords: Traffic-related air pollution
Physical activity
Exercise
Blood pressure
Heart rate variability
Arterial stiffness
Microvascular responsiveness
Muscle oxygen saturation
Lung function
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover Assignment
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Age between 40-70 years of age
2. Previously diagnosed with elevated blood pressure or hypertension by a physician

Exclusion Criteria:

1. Current or ex-smokers (abstinent for less than one year)
2. Lives with an individual who currently smokes cigarettes, e-cigarettes (i.e., vaping), or cannabis
3. Hormone replacement therapy use
4. Currently on beta-blocker or angiotensin receptor blocker (ARB) therapy
5. Currently using over the counter drugs or supplements that may alter cardiovascular measures (as per the principal investigator's discretion)
6. Prior diagnosis of any other existing cardiovascular or pulmonary diseases and/or conditions (other than hypertension)
7. Musculoskeletal injury or lower limb limitation preventing safe engagement in moderate-intensity exercise

Primary outcomes:
measure: Change from Baseline Blood Pressure at 2 Hours Post-Exposure
timeFrame: Baseline and 2 hours post-exposure
Secondary outcomes:
measure: 24-Hour Blood Pressure
timeFrame: 24 hours post-exposure
measure: Heart Rate Variability
timeFrame: Baseline and up to 24 hours post-exposure
measure: Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure
timeFrame: Baseline and 2 hours post-exposure
measure: Change from Baseline Microvascular Responsiveness at 2 Hours Post-Exposure
timeFrame: Baseline and 2 hours post-exposure
measure: Muscle Oxygen Saturation
timeFrame: Continuously throughout the 30 minute exercise bouts (during exposure)
measure: Change from Baseline FEV1 and FVC at 2 Hours Post-Exposure
timeFrame: Baseline and 2 hours post-exposure
measure: Change from Baseline FEV1/FVC at 2 Hours Post-Exposure
timeFrame: Baseline and 2 hours post-exposure
measure: Change from Baseline FEF25-75 and PEFR at 2 Hours Post-Exposure
timeFrame: Baseline and 2 hours post-exposure
measure: Severity of Symptoms
timeFrame: Baseline and 2 hours post-exposure
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: Professor
name: Michael Koehle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: