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Completed

NCT Number: NCT05092672

Physical Activity, Air Pollution, and High Blood Pressure

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.

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Key information

Conditions

Essential Hypertension Behavior Cardiovascular Diseases Hypertension Motor Activity Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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

Primary outcomes

  1. Change from Baseline Blood Pressure at 2 Hours Post-Exposure

    Time frame: Baseline and 2 hours post-exposure

    MAP, SBP, and DBP

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 25, 2021
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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