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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

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:

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

Sites / Locations

University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

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

NCT ID

NCT05092672

First Posted

September 28, 2021

Last Updated

December 12, 2022

Sponsor

University of British Columbia

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Arm Title

Low traffic-related air pollution

Arm Type

Experimental

Arm Description

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

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

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

michael.koehle@ubc.ca

First Name & Middle Initial & Last Name & Degree

Michael Koehle, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Physical Activity, Air Pollution, and High Blood Pressure

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