Trial of muscle relaxation as an aid to stopping smoking
| ISRCTN | ISRCTN70036823 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70036823 |
| Secondary identifying numbers | 1 |
- 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
Scientific
Department of Primary Care & General Practice
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 8529 |
|---|---|
| p.n.aveyard@bham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/2007 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Department of Primary Care & General Practice
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Sponsor information
University of Birmingham (UK)
University/education
University/education
Edgbaston
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 3344 |
|---|---|
| b.laverty@bham.ac.uk | |
| Website | http://www.bham.ac.uk/ |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
University/education
University of Birmingham (UK) - covering the costs of the project
No information available
NHS will pay for the treatment costs
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
