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ISRCTN
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ISRCTN70036823
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ClinicalTrials.gov identifier
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Public title
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Trial of muscle relaxation as an aid to stopping smoking
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Scientific title
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A pilot randomised controlled trial of the value of bodyscan and isometric exercises in reducing urge to smoke in smokers attempting to quit
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Acronym
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N/A
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Serial number at source
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1
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Study hypothesis
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1. To examine the uptake and use of isometric exercises and bodyscan sent by email to smokers trying to stop
2. To examine the effects of the exercises on the urge to smoke and withdrawal
3. To examine the effects of the exercises on abstinence
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Ethics approval
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Ethics approval received from the South Birmingham NHS Local Research Ethics Committee on the 21st December 2006 (ref: RD/52574/1).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Smoking cessation
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Participants - inclusion criteria
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Smokers:
1. Aged 18 years and older, either sex
2. Wanting to quit
3. Attending the smoking cessation clinic
4. Prepared to do the exercise interventions if randomised to them
5. Who have an active email address to receive the intervention material
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Participants - exclusion criteria
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Does not comply with the above inclusion criteria.
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Anticipated start date
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01/01/2007
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Anticipated end date
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31/03/2007
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Status of trial
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Completed
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Patient information material
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Target number of participants
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40
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Interventions
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Intervention:
Email of instruction sheets and mp3 files giving instructions for use when the urge to smoke strikes. Participants will be followed weekly for four weeks after quit day and asked to do the exercises as often as they can during the four weeks when the urge to smoke strikes.
Control:
Control participants will have no exercises.
Both groups receive standard smoking cessation treatment (nicotine replacement therapy plus behavioural support at the weekly sessions).
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Primary outcome measure(s)
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Primary outcomes measured and analysed on a week by week basis:
1. Reported use of exercises and helpfulness: the proportion of people that used either bodyscan or isometric exercises to deal with the urge to smoke
2. Urge to smoke: measured using the Mood and Physical Symptoms Score (MPSS) questionnaire
3. Withdrawal severity: measured using the Mood and Physical Symptoms Score (MPSS) questionnaire
Prolonged abstinence at 4 weeks measured according to the Russell standard means that lapses in the first two weeks of attempted quitting do not count against abstinence, but total abstinence must be maintained for weeks 3 - 4 and that abstinence is confirmed by exhaled carbon monoxide less than 10 ppm. Participants lost to follow up would be counted as smokers.
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Secondary outcome measure(s)
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Prolonged biochemically confirmed smoking abstinence at four weeks.
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Sources of funding
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1. University of Birmingham (UK) - covering the costs of the project
2. NHS will pay for the treatment costs
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Trial website
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Publications
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Contact name
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Dr
Paul
Aveyard
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Address
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Department of Primary Care & General Practice
University of Birmingham
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 8529
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Email
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p.n.aveyard@bham.ac.uk
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Sponsor
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University of Birmingham (UK)
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Address
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Edgbaston
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City/town
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Birmingham
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Zip/Postcode
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B15 2TT
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Country
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United Kingdom
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Tel
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+44 (0)121 414 3344
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Email
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b.laverty@bham.ac.uk
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Sponsor website:
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http://www.bham.ac.uk/
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Date applied
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31/03/2008
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Last edited
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09/05/2008
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Date ISRCTN assigned
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09/05/2008
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