Physical Activity Training Program for Patients With Alzheimer's Dementia

Study Overview
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Brief Summary
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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.

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

Conditions
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Dementia

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Exercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks) | Behavioral: Exercise<br> <br> * Other names: (RECK MotoMed®);|
| No Intervention: Treatment as usual<br>Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| activities of daily living | Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) | change from baseline after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| behavioral symptoms of dementia | Neuropsychiatric Inventory (NPI) total score | change from baseline after 12 weeks and 24 weeks | 
| cognition | Mini Mental Status Examination (MMSE) | change from baseline after 12 weeks and 24 weeks | 
| executive function and language ability | semantic and phonemic word fluency | change from baseline after 12 weeks and 24 weeks | 
| caregiver burden | Neuropsychiatric inventory (NPI) total burden score | change from baseline after 12 weeks and 24 weeks | 
| Reaction time, hand-eye quickness and attention | Ruler Drop Test | change from baseline after 12 weeks and 24 weeks | 
| activities of daily living | Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL) | change from baseline after 24 weeks |