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

NCT ID: NCT04024852

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-30
• Study Completion Date: 2019-07-31

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.

Conditions

Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Control group

The control group did daily mild exercise (walking) outdoors for 30 minutes, for maximum 70 days.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: OTHER

Intervention group

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Toronto

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Health Canada

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ling Liu

Head, Air Health Effects Research Section

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ling Liu, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Health Canada

References

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.

Reference Type: DERIVED

PMID: 31880734 (View on PubMed)

Other Identifiers

OPAHH

Identifier Type: -

Identifier Source: org_study_id