Contact information
Type
Scientific
Primary contact
Dr Paul Aveyard
ORCID ID
Contact details
Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 8529
p.n.aveyard@bham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
A pilot randomised controlled trial of the value of bodyscan and isometric exercises in reducing urge to smoke in smokers attempting to quit
Acronym
Study hypothesis
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
Ethics approval
Ethics approval received from the South Birmingham NHS Local Research Ethics Committee on the 21st December 2006 (ref: RD/52574/1).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Smoking cessation
Intervention
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).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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.
Secondary outcome measures
Prolonged biochemically confirmed smoking abstinence at four weeks.
Overall trial start date
01/01/2007
Overall trial end date
31/03/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
Does not comply with the above inclusion criteria.
Recruitment start date
01/01/2007
Recruitment end date
31/03/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Edgbaston
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 3344
b.laverty@bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Birmingham (UK) - covering the costs of the project
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS will pay for the treatment costs
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/18837976
Publication citations
-
Results
Al-Chalabi L, Prasad N, Steed L, Stenner S, Aveyard P, Beach J, Ussher M, A pilot randomised controlled trial of the feasibility of using body scan and isometric exercises for reducing urge to smoke in a smoking cessation clinic., BMC Public Health, 2008, 8, 349, doi: 10.1186/1471-2458-8-349.