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

July 18, 2014 updated by: Technische Universität Dresden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Technische Universität Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Exercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks)
Behavioral: Exercise
Other Names:
  • (RECK MotoMed®)
No Intervention: Treatment as usual
Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
behavioral symptoms of dementia
Time Frame: change from baseline after 12 weeks and 24 weeks
Neuropsychiatric Inventory (NPI) total score
change from baseline after 12 weeks and 24 weeks
cognition
Time Frame: change from baseline after 12 weeks and 24 weeks
Mini Mental Status Examination (MMSE)
change from baseline after 12 weeks and 24 weeks
executive function and language ability
Time Frame: change from baseline after 12 weeks and 24 weeks
semantic and phonemic word fluency
change from baseline after 12 weeks and 24 weeks
caregiver burden
Time Frame: change from baseline after 12 weeks and 24 weeks
Neuropsychiatric inventory (NPI) total burden score
change from baseline after 12 weeks and 24 weeks
Reaction time, hand-eye quickness and attention
Time Frame: change from baseline after 12 weeks and 24 weeks
Ruler Drop Test
change from baseline after 12 weeks and 24 weeks
activities of daily living
Time Frame: change from baseline after 24 weeks
Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)
change from baseline after 24 weeks

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

RECK-Technik GmbH & Co. KG

Investigators

  • Principal Investigator: Vjera A Holthoff, Prof., Technische Universität Dresden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

July 14, 2014

First Submitted That Met QC Criteria

July 18, 2014

First Posted (Estimate)

July 22, 2014

Study Record Updates

Last Update Posted (Estimate)

July 22, 2014

Last Update Submitted That Met QC Criteria

July 18, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTDEM-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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