NCT05092672

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

October 25, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

2.7 years

First QC Date

September 28, 2021

Last Update Submit

August 9, 2024

Conditions

Keywords

Traffic-related air pollutionPhysical activityExerciseBlood pressureHeart rate variabilityArterial stiffnessMicrovascular responsivenessMuscle oxygen saturationLung function

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Blood Pressure at 2 Hours Post-Exposure

    MAP, SBP, and DBP

    Baseline and 2 hours post-exposure

Secondary Outcomes (9)

  • 24-Hour Blood Pressure

    24 hours post-exposure

  • Heart Rate Variability

    Baseline and up to 24 hours post-exposure

  • Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure

    Baseline and 2 hours post-exposure

  • Change from Baseline Microvascular Responsiveness at 2 Hours Post-Exposure

    Baseline and 2 hours post-exposure

  • Muscle Oxygen Saturation

    Continuously throughout the 30 minute exercise bouts (during exposure)

  • +4 more secondary outcomes

Study Arms (2)

High traffic-related air pollution first

EXPERIMENTAL

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

Low traffic-related air pollution

EXPERIMENTAL

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

Interventions

ExerciseBEHAVIORAL

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

High traffic-related air pollution firstLow traffic-related air pollution

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 40-70 years of age
  • Previously diagnosed with elevated blood pressure or hypertension by a physician

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

MeSH Terms

Conditions

Essential HypertensionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Michael Koehle, MD, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 25, 2021

Study Start

November 15, 2021

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations