- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05092672
Physical Activity, Air Pollution, and High Blood Pressure
August 9, 2024 updated by: Michael Koehle, University of British Columbia
Impact of Traffic-related Air Pollution on the Cardiovascular and Pulmonary Response to Physical Activity in Patients With Hypertension
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V6T 1Z3
- University of British Columbia
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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.
|
Participants will engage in moderate-intensity (40-59% HRR) exercise for 30 min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline Blood Pressure at 2 Hours Post-Exposure
Time Frame: Baseline and 2 hours post-exposure
|
MAP, SBP, and DBP
|
Baseline and 2 hours post-exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24-Hour Blood Pressure
Time Frame: 24 hours post-exposure
|
MAP, SBP, and DBP
|
24 hours post-exposure
|
|
Heart Rate Variability
Time Frame: Baseline and up to 24 hours post-exposure
|
Indices of heart rate variability
|
Baseline and up to 24 hours post-exposure
|
|
Change from Baseline Arterial Stiffness at 2 Hours Post-Exposure
Time Frame: Baseline and 2 hours post-exposure
|
Pulse wave velocity and augmentation index
|
Baseline and 2 hours post-exposure
|
|
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)
|
Baseline and 2 hours post-exposure
|
|
Muscle Oxygen Saturation
Time Frame: Continuously throughout the 30 minute exercise bouts (during exposure)
|
Muscle oxygen saturation (measured by near-infrared spectroscopy)
|
Continuously throughout the 30 minute exercise bouts (during exposure)
|
|
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)
|
Baseline and 2 hours post-exposure
|
|
Change from Baseline FEV1/FVC at 2 Hours Post-Exposure
Time Frame: Baseline and 2 hours post-exposure
|
FEV1/FVC ratio measured by spirometry
|
Baseline and 2 hours post-exposure
|
|
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)
|
Baseline and 2 hours post-exposure
|
|
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
|
Baseline and 2 hours post-exposure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael Koehle, MD, PhD, PROFESSOR
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2021
Primary Completion (Actual)
August 1, 2024
Study Completion (Actual)
August 1, 2024
Study Registration Dates
First Submitted
September 28, 2021
First Submitted That Met QC Criteria
October 21, 2021
First Posted (Actual)
October 25, 2021
Study Record Updates
Last Update Posted (Actual)
August 12, 2024
Last Update Submitted That Met QC Criteria
August 9, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H21-01487
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Essential Hypertension
-
Addpharma Inc.Completed
-
SingHealth PolyclinicsNanyang PolytechnicEnrolling by invitationHypertension,EssentialSingapore
-
Universidade Federal de Santa MariaCompletedHealthy Volunteers | Hypertension, EssentialBrazil
-
Sulaiman AlRajhi CollegesUnknownHypertension, Essential | β-hydroxybutyrate
-
Beijing Anzhen HospitalRecruitingHypertension | Essential (Primary) HypertensionChina
-
Cytos Biotechnology AGCompletedMild Essential Hypertension | Moderate Essential HypertensionSwitzerland
-
Laboratorios Richmond S.A.C.I.F.Laboratorios Richmond Colombia SASCompletedHigh Blood Pressure (& [Essential Hypertension])Colombia
-
BayerCompletedHypertension, EssentialGermany
-
University of Kansas Medical CenterNational Institute of General Medical Sciences (NIGMS)Not yet recruitingHigh Blood Pressure (& [Essential Hypertension])
Clinical Trials on Exercise
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Aksaray University Training and Research HospitalCompletedExercise Training | Lactate Blood Increase | Cognitive Functions | BDNFTurkey (Türkiye)
-
Bayero University Kano, NigeriaCompletedChronic Low Back PainNigeria
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of Alabama at BirminghamCompletedCystic FibrosisUnited States
-
Center for Health, Exercise and Sport Sciences,...CompletedSedentary LifestyleSerbia
-
Heitor Moreno JuniorUnknown
-
Middle East Technical UniversityCompletedOsteoarthritis | Degenerative Lesion of Articular Cartilage of Knee | Articular Cartilage Disorder of KneeTurkey
-
University of LisbonFundação para a Ciência e a TecnologiaActive, not recruiting