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 |
| Protocol serial number | N0081063466 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | Leicestershire Partnership NHS Trust (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled cross-over pilot study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The effect of vibration therapy on bowel stimulation in elderly patients with dementia - a pilot study |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
1. Frequency of bowel movement |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 14/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key 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. |
| Key exclusion criteria | 1. Failure to give consent 2. Withdrawn if therapy too distressing 3. Withdrawn if too ill to continue |
| Date of first enrolment | 01/02/2000 |
| Date of final enrolment | 14/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Elderly Directorate
Leicester
LE5 0TD
United Kingdom
LE5 0TD
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/01/2018: No publications found, study status unverified.
