Blood PressureNCT04024852
Air Pollution, Physical Activity and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators
A study testing Intervention group in people with Blood Pressure, run by Health Canada.
Trial summary
This study investigated whether patients with an implanted cardioverter defibrillator (ICD) who followed advice to exercise indoors on high air pollution days had reduced adverse impacts on cardiovascular measures compared with those who exercised outdoors on those days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with structural heart disease with an implanted cardioverter difribrillator (ICD) in situ
- 18 years of age and older
- living and working in Toronto (Canada) and surrounding area
- The participants are healthy enough for mild outdoor activity (a 30-minute walk).
Who cannot join
- Decompensated heart failure (CHF) patients defined as a hospital admission for CHF or intravenous ionotropic administration within the preceding 6 months
- patients on class 1 and 11 antiarrhythmics and congenital heart disease patients
- patients who have experienced frequent or recent shocks (within the last 3 months of the experiment)
- patients who have underlying conditions that would interfere with mild daily exercise.
About this study
Official title: Air Pollution, Physical Activity and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators: A Randomized Controlled Trial of Indoor Versus Outdoor Activity
This study investigated whether patients with an implanted cardioverter defibrillator (ICD) who followed advice to exercise indoors on high air pollution days had reduced adverse impacts on cardiovascular measures compared with those who exercised outdoors on those days. Participants were randomly divided into the control and intervention groups. Both groups walked for 30 minutes outdoors every day for maximum 70 days, and their blood pressure, pulse rate and blood oxygen saturation pre- and post-exercise were measured. Hourly ambient concentrations of air pollutants were collected. On days forecast with Air Quality Health Index was equal to or higher than 5, the intervention group was advised to exercise indoors.
Read the detailed description
Background: The Air Quality Health Index (AQHI) is a risk communication tool intended to provide information to the public on current and forecast air quality conditions. It was developed by the Canadian government to help the public make decisions to limit short-term exposure to air pollution and adjust their activity when air pollution levels are high, particularly for people who are sensitive to air pollution. Little research has been done to characterize the benefits of following AQHI advice. The AQHI is based on a weighted sum of concentrations of nitrogen dioxide (NO2), ozone (O3), and particulate matter of median aerodynamic diameter ≤ 2.5 µm (PM2.5) to provide information to the public on current and forecasted air quality conditions.
Objective: This study investigated whether patients with an implanted cardioverter defibrillator (ICD) who followed advice to exercise indoors on high AQHI days had reduced adverse impacts on cardiovascular measures compared with those who exercised outdoors on those days.
Methods: Participants with ICD were randomly divided into the control and intervention group. Both groups did daily 30-minute walked outdoors for maximum 70 days, and their data on blood pressure, pulse rate and blood oxygen saturation pre- and post-exercise were collected. Hourly ambient concentrations of PM2.5, O3, NO2, sulphur dioxide (SO2) and carbon monoxide (CO) were collected, and AQHI calculated. On days forecast with AQHI ≥5, the intervention group was advised to exercise indoors. Mixed-effects models were applied to analyze the associations between air pollution and cardiovascular measures.
- Conditions
- Blood Pressure
- Being tested
- Intervention group
- Keywords
- Implanted cardioverter defibrillator, physical activity, air pollution
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
When Air Quality Health Index is below level 5, the intervention group did daily mild exercise (walking) outdoors for 30 minutes. When Air Quality Health Index is equal to or above level 5, the group is advised to do mild exercise indoors for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group did daily mild exercise (walking) outdoors for 30 minutes, for maximum 70 days. |
| Intervention group | Other | When Air Quality Health Index is below level 5, the intervention group did daily mild exercise (walking) outdoors for 30 minutes. When Air Quality Health Index is equal to or above level 5, the group is advised to do mild exercise indoors for 30 minutes. Total study period lasted for maximum 70 days. Receives: Other: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Systolic and diastolic blood pressure is measured in the dominant arm with the subject seated, using an automated sphygmomanometer (BIOS Medical, Newmarket, Ontario, Canada), taking the average of the three readings one minute apart
Measured: before and after 30-minute exercise
pulse rate
Pulse rate is measured using the pulse oximeter.
Measured: before and after 30-minute exercise
blood oxygen saturation
Oxygen saturation is measured using a pulse oximeter with a finger sensor (Choice MMed, Beijing Choice Electronic, China). The oximeter is run continuously for 3 minutes to obtain each measurement and the average oxygen saturation during this period is recorded.
Measured: before and after 30-minute exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start30 May 2016
- Primary completion8 Dec 2017
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with implanted cardioverter defibrillator (ICD) were randomly divided into the control and intervention group. Both groups did daily 30-minute walked outdoors for maximum 70 days, and their data on blood pressure, pulse rate and blood oxygen saturation pre- and post-exercise were collected. Hourly ambient concentrations of PM2.5, O3, NO2, sulphur dioxide (SO2) and carbon monoxide (CO) were collected, and AQHI calculated. On days forecast with AQHI ≥5, the intervention group was advised to exercise indoors. Mixed-effects models were applied to analyze the associations between air pollution and cardiovascular measures.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Canada
- Sponsor type
- Other government
- Collaborators
- University of Toronto, University Health Network, Toronto
- Responsible party
- Principal investigator, Ling Liu, Health Canada
- Investigators
- Ling Liu, MD, PHD, Principal investigator, Health Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024852
- Sponsor's protocol ID
- OPAHH
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu L, Urch B, Nanthakumar K, Chen L, Smith-Doiron M, Brook JR, Speck M, Silverman F, Stieb DM. Air Pollution, Physical Activity, and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators: A Randomized Controlled Trial of Indoor Versus Outdoor Activity. J Occup Environ Med. 2020 Apr;62(4):263-271. doi: 10.1097/JOM.0000000000001795.
PubMed 31880734
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Air Pollution, Physical Activity and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators: A Randomized Controlled Trial of Indoor Versus Outdoor Activity
- ClinicalTrials.gov ID
- NCT04024852
- Acronym / sponsor ID
- OPAHH
- Conditions
- Blood Pressure
- Keywords
- Implanted cardioverter defibrillator, physical activity, air pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Health CanadaOther government
- Collaborators
- University of Toronto, University Health Network, Toronto
- Study start
- 30 May 2016 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigated whether patients with an implanted cardioverter defibrillator (ICD) who followed advice to exercise indoors on high air pollution days had reduced adverse impacts on cardiovascular measures compared with those who exercised outdoors on those days. Participants were randomly divided into the control and intervention groups. Both groups walked for 30 minutes outdoors every day for maximum 70 days, and their blood pressure, pulse rate and blood oxygen saturation pre- and post-exercise were measured. Hourly ambient concentrations of air pollutants were collected. On days forecast with Air Quality Health Index was equal to or higher than 5, the intervention group was advised to exercise indoors.
Detailed description
Background: The Air Quality Health Index (AQHI) is a risk communication tool intended to provide information to the public on current and forecast air quality conditions. It was developed by the Canadian government to help the public make decisions to limit short-term exposure to air pollution and adjust their activity when air pollution levels are high, particularly for people who are sensitive to air pollution. Little research has been done to characterize the benefits of following AQHI advice. The AQHI is based on a weighted sum of concentrations of nitrogen dioxide (NO2), ozone (O3), and particulate matter of median aerodynamic diameter ≤ 2.5 µm (PM2.5) to provide information to the public on current and forecasted air quality conditions.
Objective: This study investigated whether patients with an implanted cardioverter defibrillator (ICD) who followed advice to exercise indoors on high AQHI days had reduced adverse impacts on cardiovascular measures compared with those who exercised outdoors on those days.
Methods: Participants with ICD were randomly divided into the control and intervention group. Both groups did daily 30-minute walked outdoors for maximum 70 days, and their data on blood pressure, pulse rate and blood oxygen saturation pre- and post-exercise were collected. Hourly ambient concentrations of PM2.5, O3, NO2, sulphur dioxide (SO2) and carbon monoxide (CO) were collected, and AQHI calculated. On days forecast with AQHI ≥5, the intervention group was advised to exercise indoors. Mixed-effects models were applied to analyze the associations between air pollution and cardiovascular measures.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with implanted cardioverter defibrillator (ICD) were randomly divided into the control and intervention group. Both groups did daily 30-minute walked outdoors for maximum 70 days, and their data on blood pressure, pulse rate and blood oxygen saturation pre- and post-exercise were collected. Hourly ambient concentrations of PM2.5, O3, NO2, sulphur dioxide (SO2) and carbon monoxide (CO) were collected, and AQHI calculated. On days forecast with AQHI ≥5, the intervention group was advised to exercise indoors. Mixed-effects models were applied to analyze the associations between air pollution and cardiovascular measures.
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group did daily mild exercise (walking) outdoors for 30 minutes, for maximum 70 days. |
| Intervention group | Other | Other: Intervention groupWhen Air Quality Health Index is below level 5, the intervention group did daily mild exercise (walking) outdoors for 30 minutes. When Air Quality Health Index is equal to or above level 5, the group is advised to do mild exercise indoors for 30 minutes. Total study period lasted for maximum 70 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with structural heart disease with an implanted cardioverter difribrillator (ICD) in situ
- 18 years of age and older
- living and working in Toronto (Canada) and surrounding area
- The participants are healthy enough for mild outdoor activity (a 30-minute walk).
Key exclusion criteria (4 listed)
- Decompensated heart failure (CHF) patients defined as a hospital admission for CHF or intravenous ionotropic administration within the preceding 6 months
- patients on class 1 and 11 antiarrhythmics and congenital heart disease patients
- patients who have experienced frequent or recent shocks (within the last 3 months of the experiment)
- patients who have underlying conditions that would interfere with mild daily exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupWhen Air Quality Health Index is below level 5, the intervention group did daily mild exercise (walking) outdoors for 30 minutes. When Air Quality Health Index is equal to or above level 5, the group is advised to do mild exercise indoors for 30 minutes. | Other | Intervention group |
Primary outcome
blood pressure
Time frame: before and after 30-minute exercise
Systolic and diastolic blood pressure is measured in the dominant arm with the subject seated, using an automated sphygmomanometer (BIOS Medical, Newmarket, Ontario, Canada), taking the average of the three readings one minute apart
pulse rate
Time frame: before and after 30-minute exercise
Pulse rate is measured using the pulse oximeter.
blood oxygen saturation
Time frame: before and after 30-minute exercise
Oxygen saturation is measured using a pulse oximeter with a finger sensor (Choice MMed, Beijing Choice Electronic, China). The oximeter is run continuously for 3 minutes to obtain each measurement and the average oxygen saturation during this period is recorded.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Derived from this study: PubMed 31880734Liu L, Urch B, Nanthakumar K, Chen L, Smith-Doiron M, Brook JR, Speck M, Silverman F, Stieb DM. Air Pollution, Physical Activity, and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators: A Randomized Controlled Trial of Indoor Versus Outdoor Activity. J Occup Environ Med. 2020 Apr;62(4):263-271. doi: 10.1097/JOM.0000000000001795.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Liu, MD, PHD principal investigator
Health Canada
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Blood Pressure, run by Health Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: before and after 30-minute exercise). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.