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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Andy Hung, BKin
  • Phone Number: (604) 822-6833
  • Email: kin.epl@ubc.ca

Study Locations

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: Exercise
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.
Behavioral: Exercise
Participants will engage in moderate-intensity (40-59% HRR) exercise for 30 min

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H21-01487

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.

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