Evaluation of exercise on individuals with dementia and their carers
| ISRCTN | ISRCTN01423159 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01423159 |
| Protocol serial number | N/A |
| Sponsor | Central and North West London NHS Foundation Trust (UK) |
| Funder | 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) |
- 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
Contact information
Dr David Lowery
Scientific
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 |
|---|---|
| d.lowery@ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic single-blind randomised single-centre trial |
| Secondary study design | Single-centre |
| Study type | Participant 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(s) | Behavioural and psychological symptoms measured by NPI at baseline, week 6 and 12. |
| Key secondary outcome measure(s) | 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 |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Central and North West London NHS Foundation Trust
London
NW1 7QY
United Kingdom
NW1 7QY
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? |
|---|---|---|---|---|---|
| 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 | |
| Protocol article | protocol | 13/05/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
28/08/2018: Publication reference added.
