Condition category
Mental and Behavioural Disorders
Date applied
22/04/2009
Date assigned
26/05/2009
Last edited
29/07/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.evidem.org.uk/projects/evidem-e

Contact information

Type

Scientific

Primary contact

Dr David Lowery

ORCID ID

Contact details

Central and North West London NHS Foundation Trust
Greater London House
Hampstead Road
London
NW1 7QY
United Kingdom
+44 (0)20 3214 5889
d.lowery@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A randomised controlled evaluation of exercise as a therapy for the behavioural and psychological symptoms of dementia

Acronym

EVIDEM-E

Study hypothesis

The introduction of a tailored excercise programme will significantly reduce behavioural and psychological symptoms of dementia.

Ethics approval

West London R&D Consortium, submission planned for June 2009 (as of 22/04/2009).

Study design

Pragmatic single-blind randomised single-centre trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Behavioural and psychological symptoms of dementia

Intervention

A 6-week supervised incremental course of walking outside, at a pace and distance to suit the participant and carer for at least 5 days per week. Walking is a useful exercise which is considered acceptable by participants, and is easily delivered and measured (in terms of time and distance) but rarely incorporated in a daily routine. A physiotherapist or exercise therapist will oversee the delivery of the exercise programme. The sustainability of this intervention will be assessed by evaluating adherence and impact during an unsupervised interval (weeks 6-12) and by further telephone contact at 6 months.

Control group: No exercise training

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Behavioural and psychological symptoms measured by NPI at baseline, week 6 and 12.

Secondary outcome measures

1. Participants' mental health (General Health Questionnaire) at baseline, week 6 and 12
2. Participants' quality of life (DemQOL-Proxy) at baseline, week 6 and 12
3. Caregivers' burden of caring (short Zarit Caregiver Burden Inventory) at baseline, week 6 and 12
4. Participants' level of physical activity and compliance with the intervention (diaries and heart rate monitors, to be completed by the participant and their carer)
5. Participants' and carers' views about the intervention (Diaries and semi-structured questionnaires to be carried out after the trial)
6. Mortality and domiciliary status at 6 months

Overall trial start date

01/08/2009

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, no age limits
2. Diagnosis of:
2.1. Dementia in primary or secondary care OR
2.2. Suspected dementia confirmed by the researcher to ensure the International Classification of Diseases 10th Revision (ICD-10) research criteria for dementia (DCR-10) are met
3. Presence of a carer (professional, friend or family member, who does not necessarily have to live with the participant)
4. Neuropsychiatric Inventory (NPI) score in any one sub-set except only hallucination or delusion more than or equal to 2 in severity and more than or equal to 2 in frequency
5. Consent of participant, or in the case of an individual who is not capable of giving informed consent, the assent of the participant with agreement of carer
6. Consent of carer

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

145

Participant exclusion criteria

1. Cardio-respiratory condition, neurological or musculo-skeletal condition of a degree that prevents participation to even the modified exercise regime unsafe or not possible
2. A score of three or more assessed using the Falls Risk Assessment Tool or less than one minute as assessed by the Timed Unsupported Steady Stand test
3. Uncontrolled medical problems, which the GP considers would exclude participants from undertaking the exercise programme; for example, acute systemic illness such as pneumonia, poorly controlled angina, acute rheumatoid arthritis, unstable or acute heart failure
4. Sensory impairment to an extent that prevents dyad facilitated exercise
5. Participant or carer dissent to engage in the exercise programme
6. Acute confusional state

Recruitment start date

01/08/2009

Recruitment end date

30/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Central and North West London NHS Foundation Trust
London
NW1 7QY
United Kingdom

Sponsor information

Organisation

Central and North West London NHS Foundation Trust (UK)

Sponsor details

Greater London House
Hampstead Road
London
NW1 7QY
United Kingdom

Sponsor type

Government

Website

http://www.cnwl.nhs.uk

Funders

Funder type

Government

Funder name

EVIDEM-E is funded as part of a wider programme of Research & Development via the National Institute for Health Research (NIHR) (UK) - Programme Grants for Applied Research (ref: RP-PG-0606-1005)

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

2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20465799

Publication citations

  1. Protocol

    Cerga-Pashoja A, Lowery D, Bhattacharya R, Griffin M, Iliffe S, Lee J, Leonard C, Ricketts S, Strother L, Waters F, Ritchie CW, Warner J, Evaluation of exercise on individuals with dementia and their carers: a randomised controlled trial., Trials, 2010, 11, 53, doi: 10.1186/1745-6215-11-53.

Additional files

Editorial Notes