| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN93377248 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0081063466 |
| Public title | The effect of vibration therapy on bowel stimulation in elderly patients with dementia - a pilot study |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Digestive System: Constipation |
| Study hypothesis | To examine the claim that vibration, when used regularly over a period of months can help to restore normal bowel function to persons needing medical intervention for severe constipation. |
| Design/methodology | Randomised controlled cross-over pilot study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Long-stay elderly patients (at least 20) on selected ward/nursing home areas who have moderate to severe dementia and who have constipation requiring regular laxative therapy. |
| Participants - exclusion criteria | 1. Failure to give consent
2. Withdrawn if therapy too distressing
3. Withdrawn if too ill to continue |
| Patient information material |
|
| Anticipated start date | 01/02/2000 |
| Anticipated end date | 14/12/2005 |
| Status of trial | Completed |
| Target number of participants | 20 |
| Interventions | Randomised controlled cross-over trial over twelve months. Vibration therapy will be administered via vibration pads and the effects assessed for each participant for six months with the intervention in place, and six months when it is not offered. Vibration therapy will involve patients using the pads 3 times a week for 40 minute sessions.
Group 1: Vibration for 6 months then no intervention
Group 2: No intervention, then vibration for 6 months. |
| Primary outcome measure(s) | 1. Frequency of bowel movement
2. Enema/laxative use for participants
3. Recording of adverse effects |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Leicestershire Partnership NHS Trust |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mrs Lesley Haig |
| Contact details | Elderly Directorate
Leicestershire Partnership NHS Trust
Towers Hospital
Gipsy Lane
Leicester
United Kingdom
LE5 0TD |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN93377248 |
| Date last extracted from ISRCTN register | 17/04/2008 |
