Evaluation of exercise on individuals with dementia and their carers

Not Applicable

Completed

• Conditions: Behavioural and psychological symptoms of dementia; Mental and Behavioural Disorders; Unspecified dementia

• Registration Number: ISRCTN01423159
• Lead Sponsor: Central and North West London NHS Foundation Trust (UK)

Brief Summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20465799 2. 2014 results in https://www.ncbi.nlm.nih.gov/pubmed/24338799 3. 2015 results in https://www.ncbi.nlm.nih.gov/books/NBK286184/ 4. 2016 cost-effectiveness results in https://www.ncbi.nlm.nih.gov/pubmed/26489776

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-26
• Study Completion: 2011-04-30
• Last Update Posted: 10 September 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 145

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Participants' mental health (General Health Questionnaire) at baseline, week 6 and 12<br>2. Participants' quality of life (DemQOL-Proxy) at baseline, week 6 and 12<br>3. Caregivers' burden of caring (short Zarit Caregiver Burden Inventory) at baseline, week 6 and 12<br>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) <br>5. Participants' and carers' views about the intervention (Diaries and semi-structured questionnaires to be carried out after the trial) <br>6. Mortality and domiciliary status at 6 months