ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

HIIT to Quit

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Smoking

Cardiovascular disease

Condition category

Condition code

Public Health

Health promotion/education

Cardiovascular

Coronary heart disease

Mental Health

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]

Behaviour

Intervention code [2]

Prevention

Intervention code [3]

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]

% 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]

13 and 26 weeks after randomisation

Secondary outcome [1]

Number of cigarettes smoked on a daily basis.

Self report

Timepoint [1]

Baseline, 13 and 26 weeks

Secondary outcome [2]

Withdrawal symptoms and cravings

Assessed using the Moods and Physical Symptoms Scale (MPSS)

Timepoint [2]

Weeks 3, 6, 9, 12

Secondary outcome [3]

Smoking dependency

Assessed using the Fagerstrom Test for Nicotine Dependance (FTND)

Timepoint [3]

Baseline, weeks 6, 13 and 26

Secondary outcome [4]

Subjective stress

Assessed using the Perceived Stress Scale (PSS)

Timepoint [4]

Weeks 3, 6, 9 ,12

Secondary outcome [5]

Well-being

Assessed using the SF36

Timepoint [5]

Baseline, 13 and 26 weeks

Secondary outcome [6]

Motivation

Assessed using the Behavioural Regulation in Exercise Questionnaire (BREQ-2)

Timepoint [6]

Baseline, 13 and 26 weeks

Secondary outcome [7]

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]

Baseline, 13 and 26 weeks

Secondary outcome [8]

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]

Baseline, 13 and 26 weeks

Secondary outcome [9]

Body composition

BMI (height, weight), waist circumference and waist to hip ratio

Timepoint [9]

Baseline, 13 and 26 weeks

Secondary outcome [10]

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]

Baseline, 13 and 26 weeks

Secondary outcome [11]

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]

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

Sex

Females

Can healthy volunteers participate?

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

5/12/2014

Actual

10/12/2014

Date of last participant enrolment

Anticipated

30/03/2016

Actual

30/03/2016

Date of last data collection

Anticipated

Actual

3/10/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment postcode(s) [1]

4000 - Brisbane

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Heart Foundation

Address [1]

Heart Foundation, Level 12, 500 Collins Street, Melbourne VIC 3000

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Address

Brisbane St Lucia, QLD 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Medical Research Ethics Committee

Ethics committee address [1]

Cumbrae-Stewart Building, The University of Queensland, St. Lucia, Brisbane, QLD 4072

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/11/2014

Ethics approval number [1]

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

Dr Toby Pavey

Address

School of Human Movement Studies, Blair Drive, The University of Queensland, St. Lucia Campus, Brisbane, Australia, QLD 4072

Country

Australia

Phone

+61 7 3346 9898

Fax

[email protected]

Contact person for public queries

Name

Dr Toby Pavey

Address

School of Human Movement Studies, Blair Drive, The University of Queensland, St. Lucia Campus, Brisbane, Australia, QLD 4072

Country

Australia

Phone

+61 7 3346 9898

Fax

[email protected]

Contact person for scientific queries

Name

Dr Toby Pavey

Address

School of Human Movement Studies, Blair Drive, The University of Queensland, St. Lucia Campus, Brisbane, Australia, QLD 4072

Country

Australia

Phone

+61 7 3346 9898

Fax

[email protected]

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?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
58	Study protocol				https://bmcpublichealth.biomedcentral.com/articles... [More Details]

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Conference abstract	No			367416-(Uploaded-30-10-2018-17-18-25)-Other results publication.docx

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Assessing the effectiveness of High Intensity Interval Training (HIIT) for smoking cessation in women: HIIT to quit study protocol.	2015	https://dx.doi.org/10.1186/s12889-015-2631-3

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically