Trial of muscle relaxation as an aid to stopping smoking

ISRCTN	ISRCTN70036823
DOI	https://doi.org/10.1186/ISRCTN70036823
Protocol serial number	1
Sponsor	University of Birmingham (UK)
Funders	University of Birmingham (UK) - covering the costs of the project, NHS will pay for the treatment costs

Submission date: 31/03/2008
Registration date: 09/05/2008
Last edited: 24/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Paul Aveyard
Scientific

Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 8529
Email	p.n.aveyard@bham.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Ethics approval received from the South Birmingham NHS Local Research Ethics Committee on the 21st December 2006 (ref: RD/52574/1).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Prolonged biochemically confirmed smoking abstinence at four weeks.
Completion date	31/03/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key 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
Key exclusion criteria	Does not comply with the above inclusion criteria.
Date of first enrolment	01/01/2007
Date of final enrolment	31/03/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Department of Primary Care & General Practice

Birmingham
B15 2TT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	06/10/2008		Yes	No