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

NCT04024852 | Completed

• 1 other identifier: OPAHH
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Blood Pressure

Keywords

Implanted cardioverter defibrillator; physical activity; air pollution

Outcome Measures

Primary Outcomes (3)

• 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

  before and after 30-minute exercise

• pulse rate

  Pulse rate is measured using the pulse oximeter.

  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.

  before and after 30-minute exercise

Study Arms (2)

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.

Other: Intervention group

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with structural heart disease with an implanted cardioverter difribrillator (ICD) in situ
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Health Canada: lead
• University of Toronto: collaborator
• University Health Network, Toronto: collaborator

Related Publications (1)

• 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.

  PMID: 31880734 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Ling Liu, MD, PHD

  Health Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Air Health Effects Research Section

Model Details: 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.

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 18, 2019
• Study Start: May 30, 2016
• Primary Completion: December 8, 2017
• Study Completion: July 1, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share