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Physical Activity Training Program for Patients With Alzheimer's Dementia (MOTODEM)

Primary Purpose

Dementia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise
Sponsored by
Technische Universität Dresden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Technische Universität Dresden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Treatment as usual

Arm Description

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

Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise

Outcomes

Primary Outcome Measures

activities of daily living
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)

Secondary Outcome Measures

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

Full Information

First Posted
July 14, 2014
Last Updated
July 18, 2014
Sponsor
Technische Universität Dresden
Collaborators
RECK-Technik GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT02196545
Brief Title
Physical Activity Training Program for Patients With Alzheimer's Dementia
Acronym
MOTODEM
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technische Universität Dresden
Collaborators
RECK-Technik GmbH & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Exercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks)
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Other Intervention Name(s)
(RECK MotoMed®)
Primary Outcome Measure Information:
Title
activities of daily living
Description
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
Time Frame
change from baseline after 12 weeks
Secondary Outcome Measure Information:
Title
behavioral symptoms of dementia
Description
Neuropsychiatric Inventory (NPI) total score
Time Frame
change from baseline after 12 weeks and 24 weeks
Title
cognition
Description
Mini Mental Status Examination (MMSE)
Time Frame
change from baseline after 12 weeks and 24 weeks
Title
executive function and language ability
Description
semantic and phonemic word fluency
Time Frame
change from baseline after 12 weeks and 24 weeks
Title
caregiver burden
Description
Neuropsychiatric inventory (NPI) total burden score
Time Frame
change from baseline after 12 weeks and 24 weeks
Title
Reaction time, hand-eye quickness and attention
Description
Ruler Drop Test
Time Frame
change from baseline after 12 weeks and 24 weeks
Title
activities of daily living
Description
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
Time Frame
change from baseline after 24 weeks
Other Pre-specified Outcome Measures:
Title
hippocampal cortical thickness
Description
subregional hippocampal cortical thickness based on MRI analyses
Time Frame
change from baseline after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vjera A Holthoff, Prof.
Organizational Affiliation
Technische Universität Dresden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technische Universität Dresden
City
Dresden
State/Province
Saxony
ZIP/Postal Code
01307
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
25884637
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.
Results Reference
derived

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Physical Activity Training Program for Patients With Alzheimer's Dementia

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