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Physical Activity, Air Pollution, and High Blood Pressure

Primary Purpose

Essential Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension focused on measuring Traffic-related air pollution, Physical activity, Exercise, Blood pressure, Heart rate variability, Arterial stiffness, Microvascular responsiveness, Muscle oxygen saturation, Lung function

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High traffic-related air pollution first

Low traffic-related air pollution

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Change from Baseline Blood Pressure at 2 Hours Post-Exposure
MAP, SBP, and DBP

Secondary Outcome Measures

24-Hour Blood Pressure
MAP, SBP, and DBP
Heart Rate Variability
Indices of heart rate variability
Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure
Pulse wave velocity and augmentation index
Change from Baseline Microvascular Responsiveness at 2 Hours Post-Exposure
Microvascular responsiveness (measured by near-infrared spectroscopy)
Muscle Oxygen Saturation
Muscle oxygen saturation (measured by near-infrared spectroscopy)
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)
Change from Baseline FEV1/FVC at 2 Hours Post-Exposure
FEV1/FVC ratio measured by spirometry
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)
Severity of Symptoms
Severity of respiratory symptoms (e.g., dyspnea, cough, wheeze, chest tightness) and headache on a 0-5 scale

Full Information

First Posted
September 28, 2021
Last Updated
December 12, 2022
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT05092672
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
Keywords
Traffic-related air pollution, Physical activity, Exercise, Blood pressure, Heart rate variability, Arterial stiffness, Microvascular responsiveness, Muscle oxygen saturation, Lung function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High traffic-related air pollution first
Arm Type
Experimental
Arm Description
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.
Arm Title
Low traffic-related air pollution
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants will engage in moderate-intensity (40-59% HRR) exercise for 30 min
Primary Outcome Measure Information:
Title
Change from Baseline Blood Pressure at 2 Hours Post-Exposure
Description
MAP, SBP, and DBP
Time Frame
Baseline and 2 hours post-exposure
Secondary Outcome Measure Information:
Title
24-Hour Blood Pressure
Description
MAP, SBP, and DBP
Time Frame
24 hours post-exposure
Title
Heart Rate Variability
Description
Indices of heart rate variability
Time Frame
Baseline and up to 24 hours post-exposure
Title
Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure
Description
Pulse wave velocity and augmentation index
Time Frame
Baseline and 2 hours post-exposure
Title
Change from Baseline Microvascular Responsiveness at 2 Hours Post-Exposure
Description
Microvascular responsiveness (measured by near-infrared spectroscopy)
Time Frame
Baseline and 2 hours post-exposure
Title
Muscle Oxygen Saturation
Description
Muscle oxygen saturation (measured by near-infrared spectroscopy)
Time Frame
Continuously throughout the 30 minute exercise bouts (during exposure)
Title
Change from Baseline FEV1 and FVC at 2 Hours Post-Exposure
Description
Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) measured by spirometry (in L)
Time Frame
Baseline and 2 hours post-exposure
Title
Change from Baseline FEV1/FVC at 2 Hours Post-Exposure
Description
FEV1/FVC ratio measured by spirometry
Time Frame
Baseline and 2 hours post-exposure
Title
Change from Baseline FEF25-75 and PEFR at 2 Hours Post-Exposure
Description
Forced expiratory flow at 25-75% of forced vital capacity (FEF25-75) and peak expiratory flow rate (PEFR) measured by spirometry (in L/s)
Time Frame
Baseline and 2 hours post-exposure
Title
Severity of Symptoms
Description
Severity of respiratory symptoms (e.g., dyspnea, cough, wheeze, chest tightness) and headache on a 0-5 scale
Time Frame
Baseline and 2 hours post-exposure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andy Hung, BKin
Phone
(604) 822-6833
Email
kin.epl@ubc.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Koehle, MD, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Koehle, MD, PhD
Phone
(604) 822-6833
Email
michael.koehle@ubc.ca
First Name & Middle Initial & Last Name & Degree
Michael Koehle, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical Activity, Air Pollution, and High Blood Pressure

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