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Register:	ISRCTN
Last refreshed on:	6 January 2020
Main ID:	ISRCTN26552763
Date of registration:	07/05/2015
Prospective Registration:	Yes
Primary sponsor:	Health Canada
Public title:	A study of the effectiveness of the Air Quality Health Index (AQHI) in reducing harmful effects of air pollution on the heart and lungs in adults 55 and over
Scientific title:	A randomised controlled trial of the effectiveness of the Air Quality Health Index (AQHI) in reducing cardiac and respiratory adverse effects of air pollution in adults 55 and over
Date of first enrolment:	18/05/2015
Target sample size:	80
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN26552763
Study type:	Interventional
Study design:	Single-centre randomised trial (Prevention)
Phase:	Not Applicable

Countries of recruitment
Canada

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	David Stieb
Address:	445-757 West Hastings St. - Federal Tower V6C 1A1 Vancouver Canada
Telephone:	604 666 3701
Email:	dave.stieb@hc-sc.gc.ca
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Participants must be 55 years of age or older
2. Non-smokers
3. Not exposed to environmental tobacco smoke at home
4. No seasonal allergies

Exclusion criteria:
1. Unstable angina
2. Atrial flutter
3. Atrial fibrillation
4. Paced rhythm
5. Left bundle branch block
6. Implanted cardioverter-defibrillator (ICD)
7. Participants with allergies to latex or adhesives will be excluded

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiac and respiratory health
Signs and Symptoms
Symptoms and signs involving the circulatory and respiratory systems

Intervention(s)

1. The intervention group will be asked to exercise indoors rather than outdoors and avoid other outdoor activity prior to physiological testing when the maximum AQHI is forecast to be 5 or higher (on the remaining days they will exercise outdoors). The intervention group will receive instructions for a simple indoor exercise routine that can be completed on designated days.
2. The control group will exercise outdoors daily

Primary Outcome(s)

Weekly measures before and after 30 minutes of mild activity:
1. Heart rate variability (Holter monitoring)
2. Endothelial function (Reactive Hyperemia Index - Peripheral artery tone)
3. Oxygen saturation (finger oximeter)
4. Blood pressure (automated sphygmomanometer)
5. Fraction of exhaled Nitric Oxide (exhaled NO sensor)
6. Spirometric measures (spirometer)
7. Urinary oxidative stress markers (vascular endothelial growth factor (VEGF), 8-isoprostane, malondialdehyde (MDA), 8-hydroxydeoxyguanosine (8-OHdG))

Secondary Outcome(s)

Respiratory symptoms.

Secondary ID(s)

810438

Source(s) of Monetary Support

Health Canada

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Health Canada/Public Health Agency of Canada, 23/04/2015, ref: 2012-0035.

Results

Results available:	Yes
Date Posted:
Date Completed:	31/08/2016
URL:

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