Physical Activity Training Program for Patients With Alzheimer's Dementia

Dementia Clinical Trial

— MOTODEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196545
• Other study ID #: MTDEM-001
• Status: Completed
• Phase: N/A
• First received: July 14, 2014
• Last updated: July 18, 2014
• Start date: August 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Behavioral:
• Exercise

Locations

Country	Name	City	State
Germany	Technische Universität Dresden	Dresden	Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Technische Universität Dresden	RECK-Technik GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	hippocampal cortical thickness	subregional hippocampal cortical thickness based on MRI analyses	change from baseline after 12 weeks	No
Primary	activities of daily living	Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)	change from baseline after 12 weeks	No
Secondary	behavioral symptoms of dementia	Neuropsychiatric Inventory (NPI) total score	change from baseline after 12 weeks and 24 weeks	No
Secondary	cognition	Mini Mental Status Examination (MMSE)	change from baseline after 12 weeks and 24 weeks	No
Secondary	executive function and language ability	semantic and phonemic word fluency	change from baseline after 12 weeks and 24 weeks	No
Secondary	caregiver burden	Neuropsychiatric inventory (NPI) total burden score	change from baseline after 12 weeks and 24 weeks	No
Secondary	Reaction time, hand-eye quickness and attention	Ruler Drop Test	change from baseline after 12 weeks and 24 weeks	No
Secondary	activities of daily living	Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)	change from baseline after 24 weeks	No