Condition category
Digestive System
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
13/10/2015
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

Mrs Lesley Haig

ORCID ID

Contact details

Elderly Directorate
Leicestershire Partnership NHS Trust
Towers Hospital
Gipsy Lane
Leicester
LE5 0TD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0081063466

Study information

Scientific title

The effect of vibration therapy on bowel stimulation in elderly patients with dementia - a pilot study

Acronym

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

Not provided at time of registration

Study design

Randomised controlled cross-over pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2000

Overall trial end date

14/12/2005

Reason abandoned

Eligibility

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 type

Patient

Age group

Senior

Gender

Not Specified

Target number of participants

20

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

United Kingdom

Trial participating centre

Elderly Directorate
Leicester
LE5 0TD
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leicestershire Partnership NHS Trust (UK)

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

Publication citations

Additional files

Editorial Notes