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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05092672
Other study ID # H21-01487
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date October 1, 2023

Study information

Verified date December 2022
Source University of British Columbia
Contact Andy Hung, BKin
Phone (604) 822-6833
Email kin.epl@ubc.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exercise
Participants will engage in moderate-intensity (40-59% HRR) exercise for 30 min

Locations

Country Name City State
Canada University of British Columbia Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline Blood Pressure at 2 Hours Post-Exposure MAP, SBP, and DBP Baseline and 2 hours post-exposure
Secondary 24-Hour Blood Pressure MAP, SBP, and DBP 24 hours post-exposure
Secondary Heart Rate Variability Indices of heart rate variability Baseline and up to 24 hours post-exposure
Secondary Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure Pulse wave velocity and augmentation index Baseline and 2 hours post-exposure
Secondary Change from Baseline Microvascular Responsiveness at 2 Hours Post-Exposure Microvascular responsiveness (measured by near-infrared spectroscopy) Baseline and 2 hours post-exposure
Secondary Muscle Oxygen Saturation Muscle oxygen saturation (measured by near-infrared spectroscopy) Continuously throughout the 30 minute exercise bouts (during exposure)
Secondary 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) Baseline and 2 hours post-exposure
Secondary Change from Baseline FEV1/FVC at 2 Hours Post-Exposure FEV1/FVC ratio measured by spirometry Baseline and 2 hours post-exposure
Secondary 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) Baseline and 2 hours post-exposure
Secondary Severity of Symptoms Severity of respiratory symptoms (e.g., dyspnea, cough, wheeze, chest tightness) and headache on a 0-5 scale Baseline and 2 hours post-exposure
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