Physical Activity, Air Pollution, and High Blood Pressure

Essential Hypertension Clinical Trial

Official title:

Impact of Traffic-related Air Pollution on the Cardiovascular and Pulmonary Response to Physical Activity in Patients With Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05092672
• Other study ID #: H21-01487
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

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