Physical Activity Training Program for Patients With Alzheimer's Dementia
Not Applicable
Completed
- Conditions
- Dementia
- Registration Number
- NCT02196545
- Lead Sponsor
- Technische Universität Dresden
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method activities of daily living change from baseline after 12 weeks Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
- Secondary Outcome Measures
Name Time Method caregiver burden change from baseline after 12 weeks and 24 weeks Neuropsychiatric inventory (NPI) total burden score
behavioral symptoms of dementia change from baseline after 12 weeks and 24 weeks Neuropsychiatric Inventory (NPI) total score
Reaction time, hand-eye quickness and attention change from baseline after 12 weeks and 24 weeks Ruler Drop Test
activities of daily living change from baseline after 24 weeks Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
executive function and language ability change from baseline after 12 weeks and 24 weeks semantic and phonemic word fluency
cognition change from baseline after 12 weeks and 24 weeks Mini Mental Status Examination (MMSE)
Trial Locations
- Locations (1)
Technische Universität Dresden
🇩🇪Dresden, Saxony, Germany
Technische Universität Dresden🇩🇪Dresden, Saxony, Germany