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Clinical Trials/NCT05092672
NCT05092672CompletedNot Applicable

Impact of Traffic-related Air Pollution on the Cardiovascular and Pulmonary Response to Physical Activity in Patients With Hypertension

University of British Columbia1 site in 1 country21 target enrollmentStarted: November 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
21
Locations
1
Primary Endpoint
Change from Baseline Blood Pressure at 2 Hours Post-Exposure

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • •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

Arms & Interventions

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.

Intervention: Exercise (Behavioral)

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.

Intervention: Exercise (Behavioral)

Outcomes

Primary Outcomes

Change from Baseline Blood Pressure at 2 Hours Post-Exposure

Time Frame: Baseline and 2 hours post-exposure

MAP, SBP, and DBP

Secondary Outcomes

  • Change from Baseline FEF25-75 and PEFR at 2 Hours Post-Exposure(Baseline and 2 hours post-exposure)
  • Severity of Symptoms(Baseline and 2 hours post-exposure)
  • Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure(Baseline and 2 hours post-exposure)
  • 24-Hour Blood Pressure(24 hours post-exposure)
  • Heart Rate Variability(Baseline and up to 24 hours post-exposure)
  • Change from Baseline FEV1/FVC at 2 Hours Post-Exposure(Baseline and 2 hours post-exposure)
  • Change from Baseline Microvascular Responsiveness at 2 Hours Post-Exposure(Baseline and 2 hours post-exposure)
  • Change from Baseline FEV1 and FVC at 2 Hours Post-Exposure(Baseline and 2 hours post-exposure)
  • Muscle Oxygen Saturation(Continuously throughout the 30 minute exercise bouts (during exposure))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael Koehle

Professor

University of British Columbia

Study Sites (1)

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