The effect of vibration therapy on bowel stimulation in elderly patients with dementia - a pilot study
| ISRCTN | ISRCTN93377248 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93377248 |
| Secondary identifying numbers | N0081063466 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 24/01/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Mrs Lesley Haig
Scientific
Scientific
Elderly Directorate
Leicestershire Partnership NHS Trust
Towers Hospital
Gipsy Lane
Leicester
LE5 0TD
United Kingdom
Study information
| Study design | Randomised controlled cross-over pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The effect of vibration therapy on bowel stimulation in elderly patients with dementia - a pilot study |
| 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. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Digestive System: Constipation |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 1. Frequency of bowel movement 2. Enema/laxative use for participants 3. Recording of adverse effects |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2000 |
| Overall study end date | 14/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target number of participants | 20 |
| Participant 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. |
| Participant exclusion criteria | 1. Failure to give consent 2. Withdrawn if therapy too distressing 3. Withdrawn if too ill to continue |
| Recruitment start date | 01/02/2000 |
| Recruitment end date | 14/12/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Elderly Directorate
Leicester
LE5 0TD
United Kingdom
LE5 0TD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Leicestershire Partnership NHS Trust (UK)
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 |
Editorial Notes
24/01/2018: No publications found, study status unverified.
