Trial registered on ANZCTR


Trial ID
ACTRN12609000637246
Ethics application status
Approved
Date submitted
22/07/2009
Date registered
29/07/2009
Date last updated
25/11/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise to enhance smoking cessation outcomes
Scientific title
An exercise package to increase smoking quit rates in New Zealand adults
Secondary ID [1] 253029 0
U1111-1117-7679
Universal Trial Number (UTN)
Trial acronym
Fit2Quit
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation 237331 0
Condition category
Condition code
Public Health 239649 239649 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A comprehensive exercise programme involving individual consultation and exercise prescription, face-to-face and telephone support, provision of strategies (goal setting, scheduling and planning of exercise, mood management) to maintain exercise will be provided over six months by trained exercise facilitators.
A total of ten sessions will be provided over the six months and will include one face-to-face meeting at the beginning and then weekly telephone calls for the first month, fortnightly for the next month, and then monthly for the duration of the study.
The face-to-face meeting will be approximately 60 minutes in duration with the phone calls between 10-20 minutes long.
The exercise package will be delivered in addition to usual smoking cessation services delivered through Quitline.

Quitline (Me Mutu) is a national smoking cessation service provided by the Quit Group that offers telephone delivered behavioural support (three sessions) and an eight-week supply of Nicotine Replacement Therapy (NRT) at a heavily subsidized rate for smokers.

Current standard cessation practice at the New Zealand Quitline (as at April 2008) is as follows: Quitline issues by post, two (or sometimes three) four-week Quit Cards (with a 90 day expiry) and makes routine support calls by telephone over eight weeks. These support calls are administered by Quitline advisors as required. Quitting support generally involves an average of three follow-up telephone calls, each lasting about 10-15 minutes. However, if people don’t want to receive support calls, they are not scheduled but callers are advised that they can phone Quitline at any time for support. Participants take each four-week Quit Card to a pharmacist in exchange for subsidised patches, gum and/or lozenges ($5 per item per four-week course of NRT). The strength of NRT patch, gum, and/or lozenges to be used by each participant is determined by the Quitline advisor (as per their dosage guidelines) as to the degree of each person’s nicotine dependency.

The exercise intervention will commence within one-week of participants commencing usual stop smoking treatment through Quitline, and will be provided weekly for the first six-weeks and will gradually reduce in frequency to monthly for the remainder of the programme.
Intervention code [1] 236993 0
Behaviour
Comparator / control treatment
Those in the control group will receive usual care delivered through Quitline only. Current standard cessation practice at the New Zealand Quitline (as at April 2008) is as follows: Quitline issues by post, two (or sometimes three) four-week Quit Cards (with a 90 day expiry) and makes routine support calls by telephone over eight weeks. These support calls are administered by Quitline advisors as required. Quitting support generally involves an average of three follow-up telephone calls, each lasting about 10-15 minutes. However, if people don’t want to receive support calls, they are not scheduled but callers are advised that they can phone Quitline at any time for support. Participants take each four-week Quit Card to a pharmacist in exchange for subsidised patches, gum and/or lozenges ($5 per item per four-week course of Nicotine Replacement Therapy; NRT). The strength of NRT patch, gum, and/or lozenges to be used by each participant is determined by the Quitline advisor (as per their dosage guidelines) as to the degree of each person’s nicotine dependency.
Control group
Active

Outcomes
Primary outcome [1] 238429 0
Self-reported (questionnaire) abstinence for 6 months from the quit date with no more than 5 cigarettes in total from that date, confirmed by an expired air carbon monoxide (CO) reading of less than 10ppm (as per the Russell Standard).
Timepoint [1] 238429 0
Baseline and six month follow up
Secondary outcome [1] 244922 0
Self-report (questionnaire) of not smoking single puff in the last 7-days at the completion of the study medication
Timepoint [1] 244922 0
Week 8
Secondary outcome [2] 244923 0
Self-report (questionnaire) severity of withdrawal symptoms and urges to smoke
Timepoint [2] 244923 0
Week 8
Secondary outcome [3] 244924 0
Change in body weight. Participants will be weighed on digital scales.
Timepoint [3] 244924 0
Baseline and 24 weeks
Secondary outcome [4] 244925 0
Change in physical activity. Physical activity will be assessed using the International Physical Activity Questionnaire (IPAQ).
An objective measurement of physical activity will be provided using the Actigraph accelerometer, which participants will wear for seven consecutive days.
Timepoint [4] 244925 0
IPAQ questionnaire will be assessed at baseline, weeks 8 and 24

The Actigraph accelerometer will be administered at baseline and 24 weeks only
Secondary outcome [5] 244926 0
Change in physical fitness. Participants will complete the Harvard Step test.
Timepoint [5] 244926 0
Baseline and 24 weeks

Eligibility
Key inclusion criteria
Currently interested in quitting, want to be physically active, smoke at least ten cigarettes (including roll your own) per day and smoke their first cigarette within 30 minutes of waking. Contactable by telephone and able to provide consent.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People with contraindications to regular exercise (e.g., disability, unstable angina) and with contraindications to using NRT.
Having had a myocardial infarction within the last 2 weeks; unstable or progressive angina pectoris, Prinzmetal’s angina, severe cardiac arrhythmia or a stroke in the acute phase; or are on warfarin.
Current users of NRT products or users of non-cigarette tobacco products

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)
Recruited through Quitline, contacted by researchers and screened for eligibility, sent study participant information and given an appointment time for the initial (screening) visit. At this visit trained researchers will obtain written informed consent, and collect data.
Researchers will randomise participants after the baseline assessment using a central computerised randomisation service (via a wireless connection).
A web-based participant registration system that will require entry of participant details before the computerised randomisation procedure can continue will ensure allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation, stratified to ensure balance for key prognostic factors (self-reported ethnicity, and sex).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Actual
Recruitment outside Australia
Country [1] 1912 0
New Zealand
State/province [1] 1912 0
Auckland
Country [2] 1913 0
New Zealand
State/province [2] 1913 0
Waikato

Funding & Sponsors
Funding source category [1] 237378 0
Government body
Name [1] 237378 0
Health Research Council
Address [1] 237378 0
Level 3, 110 Stanley Street, Auckland, 1010, New Zealand
Country [1] 237378 0
New Zealand
Primary sponsor type
Individual
Name
Dr Ralph Maddison
Address
Clinical Trials Research Unit, Level 4, School of Population Health, University of Auckland, Tamaki Campus, Morrin Road, Glen Innes, 1072, Auckland
Country
New Zealand
Secondary sponsor category [1] 236877 0
Individual
Name [1] 236877 0
Dr Chris Bullen
Address [1] 236877 0
Clinical Trials Research Unit, Level 4, School of Population Health, University of Auckland, Tamaki Campus, Morrin Road, Glen Innes, 1072, Auckland
Country [1] 236877 0
New Zealand
Other collaborator category [1] 784 0
Individual
Name [1] 784 0
Dr Hayden Mc Robbie
Address [1] 784 0
General Practice, Level 3, School of Population Health, University of Auckland, Tamaki Campus, Morrin Road, Glen Innes, 1072, Auckland
Country [1] 784 0
New Zealand
Other collaborator category [2] 785 0
Individual
Name [2] 785 0
Dr Marewa Glover
Address [2] 785 0
Centre for Tobacco Control, Level 4, School of Population Health, University of Auckland, Tamaki Campus, Morrin Road, Glen Innes, 1072, Auckland
Country [2] 785 0
New Zealand
Other collaborator category [3] 786 0
Individual
Name [3] 786 0
A/P Harry Prapavessis
Address [3] 786 0
Department of Kinesiology, University of Western Ontario, Ontario, N6A 3K7
Country [3] 786 0
Canada

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239510 0
Multi-region ethics committee
Ethics committee address [1] 239510 0
c/- Ministry of Health
1-3 The Terrace
Level 1
Wellington
6011
Ethics committee country [1] 239510 0
New Zealand
Date submitted for ethics approval [1] 239510 0
31/07/2009
Approval date [1] 239510 0
29/10/2009
Ethics approval number [1] 239510 0
MEC/09/08/090

Summary
Brief summary
Many people want to stop smoking but find it difficult because of withdrawal symptoms and weight gain. Exercise appears to make withdrawal easier and reduces weight gain. However; it is unclear whether exercise together with standard stop smoking support (counselling plus nicotine replacement therapy) helps more people stay free from smoking in the long term than with stop smoking support alone. To investigate this, we propose undertaking a study in which smokers who want to stop will be randomly allocated to receive either standard stop smoking treatment alone or standard stop smoking treatment plus an exercise programme. The exercise programme will run for six months and includes an exercise prescription, telephone and face-to-face support, strategies to maintain exercise levels and referral to community group exercise programmes. If the addition of this exercise intervention to standard stop smoking treatment shows it is cost-effective it will have good potential for widespread adoption.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29946 0
Address 29946 0
Country 29946 0
Phone 29946 0
Fax 29946 0
Email 29946 0
Contact person for public queries
Name 13193 0
Dr Ralph Maddison
Address 13193 0
Clinical Trials Research Unit, University of Auckland, Private Bag 92019 Auckland Mailing Centre, 1142.
Country 13193 0
New Zealand
Phone 13193 0
+649 3737599 ext 84767
Fax 13193 0
Email 13193 0
r.maddison@ctru.auckland.ac.nz
Contact person for scientific queries
Name 4121 0
Dr Ralph Maddison
Address 4121 0
Clinical Trials Research Unit, University of Auckland, Private Bag 92019 Auckland Mailing Centre, 1142.
Country 4121 0
New Zealand
Phone 4121 0
+649 3737599 ext 84767
Fax 4121 0
Email 4121 0
r.maddison@ctru.auckland.ac.nz