Physical Activity Training Program for Patients With Alzheimer's Dementia

Not Applicable

Completed

• Conditions: Dementia
• Interventions: Behavioral: Exercise

• 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

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-07
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-18
• Last Update Submitted: 2014-07-18
• Study First Posted: 2014-07-22
• Last Update Posted: 2014-07-22

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

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	Exercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks)

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
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)
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
caregiver burden	change from baseline after 12 weeks and 24 weeks	Neuropsychiatric inventory (NPI) total burden score

Trial Locations

Locations (1)

Technische Universität Dresden; 🇩🇪 Dresden, Saxony, Germany