Physical Activity Training Program for Patients With Alzheimer's Dementia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02196545

Acronym

MOTODEM

Enrollment

Registered

2014-07-22

Start date

2011-08-31

Completion date

2013-07-31

Last updated

2014-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia

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.

Interventions

BEHAVIORALExercise

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
behavioral symptoms of dementia	change from baseline after 12 weeks and 24 weeks	Neuropsychiatric Inventory (NPI) total score
cognition	change from baseline after 12 weeks and 24 weeks	Mini Mental Status Examination (MMSE)
executive function and language ability	change from baseline after 12 weeks and 24 weeks	semantic and phonemic word fluency
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)
caregiver burden	change from baseline after 12 weeks and 24 weeks	Neuropsychiatric inventory (NPI) total burden score

Other

Measure	Time frame	Description
hippocampal cortical thickness	change from baseline after 12 weeks	subregional hippocampal cortical thickness based on MRI analyses

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026