Evaluation of exercise on individuals with dementia and their carers

ISRCTN	ISRCTN01423159
DOI	https://doi.org/10.1186/ISRCTN01423159
Secondary identifying numbers	N/A

Submission date: 22/04/2009
Registration date: 26/05/2009
Last edited: 28/08/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr David Lowery
Scientific

Central and North West London NHS Foundation Trust
Greater London House
Hampstead Road
London
NW1 7QY
United Kingdom

Phone	+44 (0)20 3214 5889
Email	d.lowery@ucl.ac.uk

Study information

Study design	Pragmatic single-blind randomised single-centre trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Other
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	A randomised controlled evaluation of exercise as a therapy for the behavioural and psychological symptoms of dementia
Study acronym	EVIDEM-E
Study objectives	The introduction of a tailored excercise programme will significantly reduce behavioural and psychological symptoms of dementia.
Ethics approval(s)	West London R&D Consortium, submission planned for June 2009 (as of 22/04/2009).
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/08/2009
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	145
Key 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
Key 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
Date of first enrolment	01/08/2009
Date of final enrolment	30/04/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Central and North West London NHS Foundation Trust

London
NW1 7QY
United Kingdom

Sponsor information

Central and North West London NHS Foundation Trust (UK)
Hospital/treatment centre

Greater London House
Hampstead Road
London
NW1 7QY
England
United Kingdom

Website	http://www.cnwl.nhs.uk
"ROR"	https://ror.org/05drfg619

Funders

Funder type

Government

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)

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

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	13/05/2010	Yes	No
Results article	results	01/08/2014	Yes	No
Results article	results	01/04/2015	Yes	No
Results article	cost-effectiveness results	01/06/2016	Yes	No

Editorial Notes

28/08/2018: Publication reference added.