Clinical trial NCT02196545: Physical Activity Training Program for Patients With Alzheimer's Dementia
Official title: An Easily Accessible Physical Activity Training Program for Patients With Alzheimer's Dementia: Effect on Clinical and Neurobiological Parameters (MOTODEM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: RECK-Technik GmbH & Co. KG
First posted: 2014-07-22
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: activities of daily living
timeFrame: change from baseline after 12 weeks
Secondary outcomes:
measure: behavioral symptoms of dementia
timeFrame: change from baseline after 12 weeks and 24 weeks
measure: cognition
timeFrame: change from baseline after 12 weeks and 24 weeks
measure: executive function and language ability
timeFrame: change from baseline after 12 weeks and 24 weeks
measure: caregiver burden
timeFrame: change from baseline after 12 weeks and 24 weeks
measure: Reaction time, hand-eye quickness and attention
timeFrame: change from baseline after 12 weeks and 24 weeks
measure: activities of daily living
timeFrame: change from baseline after 24 weeks
Other outcomes:
measure: hippocampal cortical thickness
timeFrame: change from baseline after 12 weeks
Locations:
city: Dresden
country: Germany
facility: Technische Universität Dresden
state: Saxony
Study officials:
affiliation: Technische Universität Dresden
name: Vjera A Holthoff, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holthoff VA, Marschner K, Scharf M, Steding J, Meyer S, Koch R, Donix M. Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study. PLoS One. 2015 Apr 17;10(4):e0121478. doi: 10.1371/journal.pone.0121478. eCollection 2015.