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Trial registered on ANZCTR


Registration number
ACTRN12614001255673
Ethics application status
Approved
Date submitted
17/11/2014
Date registered
2/12/2014
Date last updated
31/10/2018
Date data sharing statement initially provided
31/10/2018
Date results information initially provided
31/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
High intensity interval training for smoking cessation
Scientific title
HIIT to Quit: A pilot study to evaluate the effect of high intensity interval training versus lifestyle physical activity on smoking cessation in women currently smoking at least 10 cigarettes per day
Secondary ID [1] 285649 0
None
Universal Trial Number (UTN)
Trial acronym
HIIT to Quit
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 293494 0
Cardiovascular disease 293495 0
Condition category
Condition code
Public Health 293772 293772 0 0
Health promotion/education
Cardiovascular 293773 293773 0 0
Coronary heart disease
Mental Health 293868 293868 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High intensity interval training
12 weeks duration
2 supervised (one-on-one supervision by an exercise physiologist) session per week, The 35 minute protocol consists of: warm-up at 65% HRmax (5 min); 4 x 4 minute intervals at 85-90% HRmax, interspersed with 3 minutes recovery at 65% HRmax; and cool down (5 min).
the mode of exercise will be treadmill or cycle ergometer, determined by participant preference.
1 unsupervised session using Borg Scale for intensity, using participants own equipment or environment. Borg scale intensity will correspond to the intensity indicated at the baseline measure corresponding to 85-90% HRmax.
Adherence monitored by supervised sessions attended and self report of unsupervised sessions
Participants also receive Quitline quit packs and quit apps, both the quit pack and app (available from Quitline) covers planning and preparing to quit, strategies for quit success, and coping with cravings and relapse. The quit pack and app provides two options for participants to receive this support.
Intervention code [1] 290592 0
Behaviour
Intervention code [2] 290665 0
Prevention
Intervention code [3] 290710 0
Treatment: Other
Comparator / control treatment
Lifestyle physical activity
12 week duration
Using pedometers with the aim of increasing daily steps to 10,000
A weekly phone call and sms will be provided to monitor progress and barriers. There will be no face to face supervised sessions.
Adherence monitored by log book and 10,000 steps website
Participants also receive Quitline quit packs and quit apps, both the quit pack and app (available from Quitline) covers planning and preparing to quit, strategies for quit success, and coping with cravings and relapse. The quit pack and app provides two options for participants to receive this support.
Control group
Active

Outcomes
Primary outcome [1] 293570 0
% of participants who have ceased smoking

Identified using the Russell standard, self-reported abstinence (previous 2 weeks) and carbon monoxide concentration of less than 10ppm.
Timepoint [1] 293570 0
13 and 26 weeks after randomisation
Secondary outcome [1] 311380 0
Number of cigarettes smoked on a daily basis.

Self report
Timepoint [1] 311380 0
Baseline, 13 and 26 weeks
Secondary outcome [2] 311381 0
Withdrawal symptoms and cravings

Assessed using the Moods and Physical Symptoms Scale (MPSS)
Timepoint [2] 311381 0
Weeks 3, 6, 9, 12
Secondary outcome [3] 311382 0
Smoking dependency

Assessed using the Fagerstrom Test for Nicotine Dependance (FTND)
Timepoint [3] 311382 0
Baseline, weeks 6, 13 and 26
Secondary outcome [4] 311383 0
Subjective stress

Assessed using the Perceived Stress Scale (PSS)
Timepoint [4] 311383 0
Weeks 3, 6, 9 ,12
Secondary outcome [5] 311384 0
Well-being

Assessed using the SF36
Timepoint [5] 311384 0
Baseline, 13 and 26 weeks
Secondary outcome [6] 311385 0
Motivation

Assessed using the Behavioural Regulation in Exercise Questionnaire (BREQ-2)
Timepoint [6] 311385 0
Baseline, 13 and 26 weeks
Secondary outcome [7] 311386 0
Cardiorespiratory fitness (VO2max)

The fitness test will be the Modified Bruce Protocol Stress Test. The treadmill is started at 2.74 km/hr (1.7 mph) and at a gradient (or incline) of 0%. The incline and speed of the treadmill increases every three minutes.The participant must breathe through a tube while exercising, for analysis of oxygen and carbon dioxide concentrations (metabolic cart). They must wear a nose-peg to ensure complete breathing through the mouth. The participant will rate their perceived exertion (Rating of Perceived Exertion – Borg scale) every 3 minutes during the test. The test will stop when they want it to, which will be communicated to the researcher using a hand signal.
Timepoint [7] 311386 0
Baseline, 13 and 26 weeks
Secondary outcome [8] 311387 0
Lung function

forced vital capacity [FVC], forced expiratory volume in 1 second [FEV1], FEV1/ FVC ratio, and peak expiratory flow rate [PEFR]) will be assessed using a Vitalograph
Timepoint [8] 311387 0
Baseline, 13 and 26 weeks
Secondary outcome [9] 311388 0
Body composition

BMI (height, weight), waist circumference and waist to hip ratio
Timepoint [9] 311388 0
Baseline, 13 and 26 weeks
Secondary outcome [10] 311389 0
Physical activity and sedentary behaviour

Measured using a wrist-worn GENEActiv tri-axial accelerometer for a 7-day period at each time-point.
Timepoint [10] 311389 0
Baseline, 13 and 26 weeks
Secondary outcome [11] 311390 0
Demographic information

A self-report questionnaire designed for the study will include questions related to age, education, occupation, income, health history, smoking history
Timepoint [11] 311390 0
Baseline, 13 and 26 weeks with relevant repeated questions

Eligibility
Key inclusion criteria
Currently smoking at least 10 cigarettes per day
Want to quit
Willing to exercise (able to attend the gym twice weekly)
Minimum age
18 Years
Maximum age
35 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Already using pharmacological quit smoking aids
Medical problems that increase risk of exercise adverse events (including unstable angina, pulmonary disease, uncontrolled hypertension, cardiomyopathty, orthepedic or neurological limitations)
Planned operation during research period
Current or planned pregnancy
Drug or alcohol abuse
Reluctance to sign consent form

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants who meet the eligibility criteria will be randomised into one of 2 groups: 1) HITT or 2) 10,000 steps. The randomisation will be conducted at UQ by a statistician not associated with the trial. The allocation will be provided to us via email
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer program will be used to generate the random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This pilot study aims to assess the feasibility of conducting an RCT to compare the efficacy of two exercise interventions for smoking cessation. We will use the results to inform the sample size for a larger trial, and to evaluate the potential utility of using each of the measures in women who smoke. Funding allows for 80 participants (40 per group). Descriptive statistics will be used to summarize characteristics of participants in each group, and to describe those who successfully quit. Analysis of the primary outcome will be by Yates’ corrected Chi-squared test for differences in the proportions who quit in each group. Changes in categorical (eg smoking abstinence) and continuous (eg number of cigarettes smoked) variables will be assessed using general linear modeling.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 8894 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 290235 0
Charities/Societies/Foundations
Name [1] 290235 0
Heart Foundation
Address [1] 290235 0
Heart Foundation, Level 12, 500 Collins Street, Melbourne VIC 3000
Country [1] 290235 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Brisbane St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 288942 0
None
Name [1] 288942 0
Address [1] 288942 0
Country [1] 288942 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291938 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [1] 291938 0
Cumbrae-Stewart Building, The University of Queensland, St. Lucia, Brisbane, QLD 4072
Ethics committee country [1] 291938 0
Australia
Date submitted for ethics approval [1] 291938 0
Approval date [1] 291938 0
03/11/2014
Ethics approval number [1] 291938 0
2014001266

Summary
Brief summary
The aims of this project are: (1) compare the effects of two exercise interventions (High Intensity Interval Training [HIIT] and 10,000 steps) combined with usual care smoking cessation support, on the cessation rates of female smokers wishing to quit; (2) assess the effects of HIIT and 10,000 steps for weight management during quit attempts; and (3) assess whether improvements in fitness, vitality and intrinsic motivation are mediators of the relationship between HITT and smoking cessation. We hypothesise that HIIT will provide higher smoking cessation rates than 10,000 steps.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52722 0
Dr Toby Pavey
Address 52722 0
School of Human Movement Studies, Blair Drive, The University of Queensland, St. Lucia Campus, Brisbane, Australia, QLD 4072
Country 52722 0
Australia
Phone 52722 0
+61 7 3346 9898
Fax 52722 0
Email 52722 0
t.pavey@uq.edu.au
Contact person for public queries
Name 52723 0
Dr Toby Pavey
Address 52723 0
School of Human Movement Studies, Blair Drive, The University of Queensland, St. Lucia Campus, Brisbane, Australia, QLD 4072
Country 52723 0
Australia
Phone 52723 0
+61 7 3346 9898
Fax 52723 0
Email 52723 0
t.pavey@uq.edu.au
Contact person for scientific queries
Name 52724 0
Dr Toby Pavey
Address 52724 0
School of Human Movement Studies, Blair Drive, The University of Queensland, St. Lucia Campus, Brisbane, Australia, QLD 4072
Country 52724 0
Australia
Phone 52724 0
+61 7 3346 9898
Fax 52724 0
Email 52724 0
t.pavey@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
trial data yet to be published
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 58 0
Study protocol
Citation [1] 58 0
Link [1] 58 0
Email [1] 58 0
Other [1] 58 0
https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-015-2631-3
Attachment [1] 58 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 60 0
Conference abstract
Citation/DOI/link/details [1] 60 0
Results – basic reporting
Results – plain English summary