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Physical Activity, Air Pollution, and High Blood Pressure

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ClinicalTrials.gov Identifier: NCT05092672
Recruitment Status : Not yet recruiting
First Posted : October 25, 2021
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Koehle, University of British Columbia

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.

Condition or disease Intervention/treatment Phase
Essential Hypertension Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Traffic-related Air Pollution on the Cardiovascular and Pulmonary Response to Physical Activity in Patients With Hypertension
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Change from Baseline Blood Pressure at 2 Hours Post-Exposure [ Time Frame: Baseline and 2 hours post-exposure ]
    MAP, SBP, and DBP


Secondary Outcome Measures :
  1. 24-Hour Blood Pressure [ Time Frame: 24 hours post-exposure ]
    MAP, SBP, and DBP

  2. Heart Rate Variability [ Time Frame: Baseline and up to 24 hours post-exposure ]
    Indices of heart rate variability

  3. Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure [ Time Frame: Baseline and 2 hours post-exposure ]
    Pulse wave velocity and augmentation index

  4. 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)

  5. Muscle Oxygen Saturation [ Time Frame: Continuously throughout the 30 minute exercise bouts (during exposure) ]
    Muscle oxygen saturation (measured by near-infrared spectroscopy)

  6. 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)

  7. Change from Baseline FEV1/FVC at 2 Hours Post-Exposure [ Time Frame: Baseline and 2 hours post-exposure ]
    FEV1/FVC ratio measured by spirometry

  8. 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)

  9. 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



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05092672


Contacts
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Contact: Andy Hung, BKin (604) 822-6833 kin.epl@ubc.ca

Locations
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Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada, V6T 1Z3
Contact: Michael Koehle, MD, PhD    (604) 822-6833    michael.koehle@ubc.ca   
Principal Investigator: Michael Koehle, MD, PhD         
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Michael Koehle, MD, PhD Professor
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Responsible Party: Michael Koehle, Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT05092672    
Other Study ID Numbers: H21-01487
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael Koehle, University of British Columbia:
Traffic-related air pollution
Physical activity
Exercise
Blood pressure
Heart rate variability
Arterial stiffness
Microvascular responsiveness
Muscle oxygen saturation
Lung function
Additional relevant MeSH terms:
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Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases