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Trial registered on ANZCTR


Registration number
ACTRN12613001014741
Ethics application status
Approved
Date submitted
9/09/2013
Date registered
11/09/2013
Date last updated
17/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Acute Effects of a Single Bout of Exercise on Asthmatic Airway Inflammation: A Pilot Study
Scientific title
The Acute Effects of a Single Bout of Exercise on Asthmatic Airway Inflammation
Secondary ID [1] 283166 0
Nil
Universal Trial Number (UTN)
Trial acronym
ExI Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 290026 0
Condition category
Condition code
Respiratory 290405 290405 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will attend four visits.

Visit 1: Two hours prior to visit 1, participants will be directed to consume a carbohydrate-based breakfast (caffeine free). On arrival at the clinic, participants will perform spirometry and plethysmography, have a venous blood sample collected and exhaled nitric oxide (eNO) measured. Participants will then be treated with 400mcg inhaled salbutamol via spacer and spirometry performed 15-minutes post-bronchodilator. Participants will be randomised to complete one of the following interventions: 1) 30-minutes of moderate-intensity exercise on a treadmill or 2) 30-minutes of rest. Moderate-intensity exercise will be performed at 60-80% of the age predicted maximum heart rate. At 0, 1 and 2 hours post-exercise/rest a venous blood sample will be collected, eNO measured and spirometry performed. eNO will also be measured and spirometry perfomed 0.5 hours and 4 hours post-exercise. Participants will be instructed to maintain a food diary for the entire day and breakfast the following morning.

Visit 2: Visit 2 will be conducted 24 hours after visit 1. Two hours prior to visit 2, participants will be directed to consume the same breakfast they had prior to visit 1. On arrival at the clinic, participants will perform spirometry, have a venous blood sample collected, exhaled nitric oxide (eNO) measured and have an allergy skin prick test. Participants will also complete 7 days of pedometry between visit 2 and visit 3.

Visit 3: Visit 3 will be conducted 4 weeks after visit 2. Two hours prior to this visit, participants will be directed to consume the same breakfast as they had prior to visit 1. On arrival at the clinic, participants will perform spirometry, have a venous blood sample collected and exhaled nitric oxide (eNO) measured. Participants will then be treated with 400mcg inhaled salbutamol via spacer and spirometry performed 15-minutes post-bronchodilator. Participants will be randomised to complete the alternate intervention to visit 1: either 1) 30-minutes of moderate-intensity exercise on a treadmill or 2) 30-minutes of rest. Moderate-intensity exercise will be performed at 60-80% of the age predicted maximum heart rate. At 0, 1 and 2 hours post-exercise/rest a venous blood sample will be collected, eNO measured and spirometry performed. eNO will also be measured and spirometry perfomed 0.5 hours and 4 hours post-exercise. Participants will be directed to have the same foods for the entire day as they had during visit 1. Participants will be instructed to maintain a food diary for the entire day and breakfast the following morning.

Visit 4: Visit 4 will be conducted 24 hours after visit 3. Two hours prior to visit 4, participants will be directed to consume the same breakfast they had prior to visit 1. On arrival at the clinic, participants will perform spirometry, have a venous blood sample collected and eNO measured.
Intervention code [1] 287896 0
Lifestyle
Comparator / control treatment
The comparator or control treatment will be no exercise, where the participant will rest in a chair for 30 minutes.
Control group
Active

Outcomes
Primary outcome [1] 290429 0
Exhaled nitric oxide (eNO), which will be measured using an Ecomedics nitric oxide analyser.
Timepoint [1] 290429 0
0, 1, 2, 4 and 24 hours (versus baseline)
Secondary outcome [1] 304504 0
Plasma eosinophil count
Timepoint [1] 304504 0
0, 1, 2 and 24 hours (versus baseline)
Secondary outcome [2] 304539 0
Plasma Interleukin (IL)-5
Timepoint [2] 304539 0
0, 1, 2 and 24 hours (versus baseline)
Secondary outcome [3] 304540 0
Plasma IL-4
Timepoint [3] 304540 0
0, 1, 2 and 24 hours (versus baseline)
Secondary outcome [4] 304541 0
Plasma IL-10
Timepoint [4] 304541 0
0, 1, 2 and 24 hours (versus baseline)
Secondary outcome [5] 304542 0
C-reactive protein (CRP)
Timepoint [5] 304542 0
0, 1, 2 and 24 hours (versus baseline)

Eligibility
Key inclusion criteria
Doctor diagnosed asthma; stable asthma (no respiratory tract infection, oral corticosteroid use or antibiotic use in the 4 weeks preceding the intervention visits); 18-65 years of age and body mass index (BMI) <=40kg/m2; never or ex-smokers (last cigarette at least 6 months prior); FEV1 >50% predicted. GP clearance for exercise must be provided for females aged >50 years, males aged >40 years, and all participants who respond ‘yes’ to any question in Part A of the “Adult Pre-Exercise Screening Tool”.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current smoker; cardiac contraindication to exercise; cancer; pregnancy or breastfeeding; currently undertaking exercise training (>=90 minutes per week); any issue that in the opinion of the investigator would impede the participants safety and/or ability to undertake the exercise intervention; participation in an exercise session within 3 days of the scheduled study visit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After screening for eligibility, participants will be assigned to the next available study number. Allocation will be concealed by blinded list held by an independent statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence, using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Because this is a pilot study, sample size could not be calculated. Therefore n=20 participants will be recruited. Repeated measures ANOVA will be performed to examine the effects of exercise on systemic and airway inflammation at each time point. Associations between change in exhaled nitric oxide concentration and markers of systemic inflammation will be examined using Spearman rank correlations. P-values =0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/10/2013
Actual
14/10/2013
Date of last participant enrolment
Anticipated
Actual
25/07/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 287920 0
Hospital
Name [1] 287920 0
John Hunter Hospital Charitable Trust
Country [1] 287920 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Hunter Medical Research Institute
Address
Hunter Medical Research Institute
Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 286648 0
Hospital
Name [1] 286648 0
John Hunter Hospital
Address [1] 286648 0
John Hunter Hospital
Lookout Road,
New Lambton Heights NSW 2305
Country [1] 286648 0
Australia
Other collaborator category [1] 277608 0
University
Name [1] 277608 0
University of Newcastle
Address [1] 277608 0
University of Newcastle
University Drive,
Callaghan NSW 2308
Country [1] 277608 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289851 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 289851 0
Ethics committee country [1] 289851 0
Australia
Date submitted for ethics approval [1] 289851 0
30/08/2013
Approval date [1] 289851 0
08/10/2013
Ethics approval number [1] 289851 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42766 0
Dr Hayley Scott
Address 42766 0
Centre for Asthma and Respiratory Diseases
Level 2 West Wing, HMRI Building
Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305
Country 42766 0
Australia
Phone 42766 0
+61 2 4042 0113
Fax 42766 0
+ 61 2 4042 0046
Email 42766 0
Hayley.Scott@newcastle.edu.au
Contact person for public queries
Name 42767 0
Hayley Scott
Address 42767 0
Centre for Asthma and Respiratory Diseases
Level 2 West Wing, HMRI Building
Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305
Country 42767 0
Australia
Phone 42767 0
+61 2 4042 0113
Fax 42767 0
+ 61 2 4042 0046
Email 42767 0
Hayley.Scott@newcastle.edu.au
Contact person for scientific queries
Name 42768 0
Hayley Scott
Address 42768 0
Centre for Asthma and Respiratory Diseases
Level 2 West Wing, HMRI Building
Lot 1 Kookaburra Circuit
New Lambton Heights NSW 2305
Country 42768 0
Australia
Phone 42768 0
+61 2 4042 0113
Fax 42768 0
+ 61 2 4042 0046
Email 42768 0
Hayley.Scott@newcastle.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAcute exercise is associated with reduced exhaled nitric oxide in physically inactive adults with asthma.2015https://dx.doi.org/10.1016/j.anai.2015.04.002
N.B. These documents automatically identified may not have been verified by the study sponsor.