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CompletedNCT02196545MOTODEMUpdated Jul 22, 2014

Physical Activity Training Program for Patients With Alzheimer's Dementia

An interventional study of Exercise in Dementia, sponsored by Technische Universität Dresden. Completed at 1 site in Germany. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2014-07-22.

Sponsored by Technische Universität Dresden · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dementia

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03

In context

Dementia

2,230 studies on the registry are indexed under Dementia; 549 are open to participants now.

This study's enrollment of 30 is below the median of 83 across 1,669 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Technische Universität Dresden is the lead sponsor of 247 studies on the registry; 46 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Exercise

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

    Behavioral: Exercise

  • 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

Interventions

  • BehavioralExercise

    Also known as: (RECK MotoMed®)

06

What researchers measure

Primary outcomes

  1. activities of daily living

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

    Time frame: change from baseline after 12 weeks

Secondary outcomes

  1. behavioral symptoms of dementia

    Neuropsychiatric Inventory (NPI) total score

    Time frame: change from baseline after 12 weeks and 24 weeks

  2. cognition

    Mini Mental Status Examination (MMSE)

    Time frame: change from baseline after 12 weeks and 24 weeks

  3. executive function and language ability

    semantic and phonemic word fluency

    Time frame: change from baseline after 12 weeks and 24 weeks

  4. caregiver burden

    Neuropsychiatric inventory (NPI) total burden score

    Time frame: change from baseline after 12 weeks and 24 weeks

  5. Reaction time, hand-eye quickness and attention

    Ruler Drop Test

    Time frame: change from baseline after 12 weeks and 24 weeks

  6. activities of daily living

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

    Time frame: change from baseline after 24 weeks

Other outcomes

  1. hippocampal cortical thickness

    subregional hippocampal cortical thickness based on MRI analyses

    Time frame: change from baseline after 12 weeks

07

Study locations

1 site
  • Technische Universität Dresden
    Dresden, Saxony 01307, Germany
08

References and documents

Publications

  • 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. PubMed 25884637 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Aug 2011, a primary completion of Jul 2013 and a completion of Jul 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 14, 2014
First posted
Jul 22, 2014
Start
Aug 2011
Primary completionActual
Jul 2013
CompletionActual
Jul 2013
Last update
Jul 22, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02196545
Lead sponsor
Technische Universität Dresden
Collaborators
RECK-Technik GmbH & Co. KG
Responsible party
Sponsor
First posted
Jul 22, 2014
Start date
Aug 2011
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jul 22, 2014

Study contacts

Vjera A Holthoff, Prof.
principal investigator · Technische Universität Dresden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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