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Completed

NCT Number: NCT02196545

Physical Activity Training Program for Patients With Alzheimer's Dementia

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Technische Universität Dresden

Dresden, Saxony, 01307, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Other names: (RECK MotoMed®)

Primary outcomes

  1. activities of daily living

    Time frame: change from baseline after 12 weeks

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

Secondary outcomes

  1. behavioral symptoms of dementia

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

    Neuropsychiatric Inventory (NPI) total score

  2. cognition

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

    Mini Mental Status Examination (MMSE)

  3. executive function and language ability

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

    semantic and phonemic word fluency

  4. caregiver burden

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

    Neuropsychiatric inventory (NPI) total burden score

  5. Reaction time, hand-eye quickness and attention

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

    Ruler Drop Test

  6. activities of daily living

    Time frame: change from baseline after 24 weeks

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

Other outcomes

  1. hippocampal cortical thickness

    Time frame: change from baseline after 12 weeks

    subregional hippocampal cortical thickness based on MRI analyses

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Collaborators

  • RECK-Technik GmbH & Co. KG

Registry information

Official study title

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

Acronym: MOTODEM

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 22, 2014
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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