Condition category
Mental and Behavioural Disorders
Date applied
31/03/2008
Date assigned
09/05/2008
Last edited
24/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.bham.ac.uk/

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18837976

Publication citations

  1. 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.

Additional files

Editorial Notes