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出境医 / 临床实验 / Air Pollution, Physical Activity and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators

Air Pollution, Physical Activity and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators

Study Description
Brief 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. 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.

Condition or disease Intervention/treatment Phase
Blood Pressure Other: Intervention group Not Applicable

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Air Pollution, Physical Activity and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators: A Randomized Controlled Trial of Indoor Versus Outdoor Activity
Actual Study Start Date : May 30, 2016
Actual Primary Completion Date : December 8, 2017
Actual Study Completion Date : July 2019
Arms and Interventions
Arm Intervention/treatment
No Intervention: Control group
The control group did daily mild exercise (walking) outdoors for 30 minutes, for maximum 70 days.
Intervention group
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.
 Other: Intervention group
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.
Outcome Measures
Primary Outcome Measures :
  1. 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

  2. pulse rate [ Time Frame: before and after 30-minute exercise ]
    Pulse rate is measured using the pulse oximeter.

  3. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Contacts and Locations

Sponsors and Collaborators
Health Canada
University of Toronto
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Ling Liu, MD, PHD Health Canada
Tracking Information
First Submitted Date  ICMJE July 12, 2019
First Posted Date  ICMJE July 18, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date  ICMJE May 30, 2016
Actual Primary Completion Date December 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Air Pollution, Physical Activity and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators
Official Title  ICMJE Air Pollution, Physical Activity and Cardiovascular Function of Patients With Implanted Cardioverter Defibrillators: A Randomized Controlled Trial of Indoor Versus Outdoor Activity
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE Blood Pressure
Intervention  ICMJE Other: Intervention group
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 Arms  ICMJE
  • No Intervention: Control group
    The control group did daily mild exercise (walking) outdoors for 30 minutes, for maximum 70 days.
  • Intervention group
    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.
    Intervention: Other: Intervention group
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2019) 		18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2019
Actual Primary Completion Date December 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04024852
Other Study ID Numbers  ICMJE OPAHH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ling Liu, Health Canada
Study Sponsor  ICMJE Health Canada
Collaborators  ICMJE
  • University of Toronto
  • University Health Network, Toronto
Investigators  ICMJE
Principal Investigator: Ling Liu, MD, PHD Health Canada
PRS Account Health Canada
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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