Physical Activity, Air Pollution, and High Blood Pressure

August 9, 2024 updated by: Michael Koehle, University of British Columbia

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 1Z3
        • University of British Columbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High traffic-related air pollution first
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.
Participants will engage in moderate-intensity (40-59% HRR) exercise for 30 min
Experimental: Low traffic-related air pollution
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.
Participants will engage in moderate-intensity (40-59% HRR) exercise for 30 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Blood Pressure at 2 Hours Post-Exposure
Time Frame: Baseline and 2 hours post-exposure
MAP, SBP, and DBP
Baseline and 2 hours post-exposure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-Hour Blood Pressure
Time Frame: 24 hours post-exposure
MAP, SBP, and DBP
24 hours post-exposure
Heart Rate Variability
Time Frame: Baseline and up to 24 hours post-exposure
Indices of heart rate variability
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
Pulse wave velocity and augmentation index
Baseline and 2 hours post-exposure
Change from Baseline Microvascular Responsiveness at 2 Hours Post-Exposure
Time Frame: Baseline and 2 hours post-exposure
Microvascular responsiveness (measured by near-infrared spectroscopy)
Baseline and 2 hours post-exposure
Muscle Oxygen Saturation
Time Frame: Continuously throughout the 30 minute exercise bouts (during exposure)
Muscle oxygen saturation (measured by near-infrared spectroscopy)
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
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) measured by spirometry (in L)
Baseline and 2 hours post-exposure
Change from Baseline FEV1/FVC at 2 Hours Post-Exposure
Time Frame: Baseline and 2 hours post-exposure
FEV1/FVC ratio measured by spirometry
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
Forced expiratory flow at 25-75% of forced vital capacity (FEF25-75) and peak expiratory flow rate (PEFR) measured by spirometry (in L/s)
Baseline and 2 hours post-exposure
Severity of Symptoms
Time Frame: Baseline and 2 hours post-exposure
Severity of respiratory symptoms (e.g., dyspnea, cough, wheeze, chest tightness) and headache on a 0-5 scale
Baseline and 2 hours post-exposure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael Koehle, MD, PhD, PROFESSOR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 25, 2021

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Essential Hypertension

Clinical Trials on Exercise

Subscribe