An Easily Accessible Physical Activity Training Program for Patients With Alzheimer's Dementia: Effect on Clinical and Neurobiological Parameters (MOTODEM)

Technische Universität Dresden1 site in 1 country30 target enrollmentAugust 2011

ConditionsDementia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Dementia
Sponsor: Technische Universität Dresden
Enrollment: 30
Locations: 1
Primary Endpoint: activities of daily living
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if a home based physical activity training program for patients with Alzheimer's dementia has effects on clinical and neurobiological parameters.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

July 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Technische Universität Dresden

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•age \>55 years
•German is the dominant language (necessary for neuropsychological testing)
•minimum of 8 years formal school education
•caregiver (e.g. spouse) living at home with participant
•physical examination does not reveal contraindications to physical activity
•stable dose of pharmacological dementia treatment according to German guidelines (DGPPN) with acetylcholinesterase inhibitor or memantin or combination for at least 6 months
•no other medication that could influence cognitive functioning (e.g. benzodiazepines, sleep aids, neuroleptics)

Exclusion Criteria

•history of neurological or psychiatric disease other than AD
•history of substance abuse disorder
•history of electroconvulsive therapy (ECT) during the last 6 months
•structural brain deficits diagnosed in the MRI scan, also without clinical relevance (incidental finding)
•pacemaker, artificial heart valve, insulin pump or other medical implants
•average steps/day are above 10.000 steps/day

Outcomes

Primary Outcomes

activities of daily living

Time Frame: change from baseline after 12 weeks

Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)

Secondary Outcomes

executive function and language ability(change from baseline after 12 weeks and 24 weeks)
caregiver burden(change from baseline after 12 weeks and 24 weeks)
behavioral symptoms of dementia(change from baseline after 12 weeks and 24 weeks)
Reaction time, hand-eye quickness and attention(change from baseline after 12 weeks and 24 weeks)
activities of daily living(change from baseline after 24 weeks)
cognition(change from baseline after 12 weeks and 24 weeks)