Aim of the Project

To answer the question: Does a programme of exercise and physical activity improve cognition for people with mild to moderate dementia?

Trial Summary

The DAPA trial aimed to establish whether exercise is effective in treating against functional and cognitive decline in community dwelling adults with mild to moderate dementia. It was a randomised controlled trial to recruit 468 participants to compare an additional structured exercise regimen to best usual care. The structured exercise intervention was to be carried out over a 4 month period with a transition to community based sustainable physical activity.

Eligibility Criteria

Potential participants will be eligible for inclusion if they meet each of the following criteria:

1. Probable dementia according to the Diagnostic and Statistical Manual, 4^th Edition (DSM IV) criteria:

a. Memory impairment with cognitive disturbance in at least one of the following domains - aphasia (language), apraxia (motor activities), agnosia (object recognition) or executive functioning (planning, sequencing, abstracting)

b. Functional decline: increasing impairment in functional ability (social, occupational, personal/self-care) related to cognitive deficits.

2. Probable dementia of mild to moderate severity (MMSE >10).

3. Are able to participate in a structured exercise programme:

a. able to sit on a chair and to walk 10 feet without human assistance;

b. no serious unstable illness (e.g. unstable angina)

4. Live in the community, either alone or with a relative, friend, or carer, or in sheltered accommodation.

Exclusion criteria:

1. People with severe dementia (MMSE ≤10) will not be eligible for inclusion.

2. Acute, unstable or terminal illness which would make participation in the exercise group impractical.

3. People living in residential nursing homes will not be eligible for inclusion.

What is Being Tested?

We are testing the DAPA exercise programme. Participants in the trial will be randomised to one of two arms:

a) Their usual care
b) Their usual care plus the DAPA exercise programme.

The DAPA exercise programme will consist of:

• Exercise classes to be held twice a week at a local venue for 4 months: A specially trained physiotherapist and one assistant will take each class; exercise will be done using static exercise bicycles and free weights; exercising at a level to improve aerobic fitness and muscle strength. Behavioural change support activities aimed at improving adherence to both parts of the exercise programme will be provided for 12 months.

• On the other days of the week, everyone taking part in the classes will be encouraged to add another hour of exercise to their weekly routine for at least one hour.
• Once the 4 months of classes have been completed, everyone will be encouraged to continue exercising regularly at home or in the community for the next 8 months.

The trial will run for one year; participants will be contacted for follow up assessments at six months and one year.

Funder

HTA 09/80/04

Sponsor

University of Warwick

Chief Investigator

Professor Sarah Lamb

Schedule

Start date: 1 April 2012

End date: 30 September 2016