Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01061489
Recruitment Status : Completed
First Posted : February 3, 2010
Last Update Posted : July 14, 2016
University of Ulm
Information provided by (Responsible Party):
Iris-Tatjana Kolassa, University of Ulm

Brief Summary:

Age-related cognitive decline is unavoidable. However, recent results of neuroplasticity-based research show that neuroplasticity-based training and physical activity might have the potential to decelerate or even reverse effects of aging and age-related cognitive impairments. Little is known whether these results also apply to pathological processes of aging such as mild cognitive impairment (MCI) and dementia.

This multi-center study aims at investigating efficiency and feasibility of a neuroplasticity-based auditory discrimination training and a physical fitness training for patients suffering from mild cognitive impairment or mild Alzheimer's disease (Mini Mental State Examination, MMSE > 19). Evaluation will include neuropsychological testing, electroencephalography (EEG) and magnetic resonance imaging (MRI) measurements as well as blood and liquor analyses.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment (MCI) Mild Alzheimer's Disease Other: auditory discrimination training Other: physical movement training Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Computer-based Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)
Study Start Date : August 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Experimental: sensory-cognitive training Other: auditory discrimination training
10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home

Experimental: physical fitness Other: physical movement training
10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week)

No Intervention: waiting list (control group)

Primary Outcome Measures :
  1. Change in global cognition [ Time Frame: pre, post, 3-month follow-up ]
    Average score of the two component scores "memory" and "attention / executive functions", derived from principal component analysis of 11 cognitive items (Munich verbal memory test (MVGT) encoding, MVGT long delayed free recall, free recall of the Alzheimer's Disease Assessment Scale, working memory in the Everyday Cognition Battery, Trail Making Test A and B, digit span forward and backward, digit-symbol-coding and semantic and phonematic fluency).

Secondary Outcome Measures :
  1. electrophysiological, MRI, blood and liquor correlates [ Time Frame: pre, post, 3-month follow-up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • focus: subjective and/or objective memory complaints with MMSE > 19 (MCI or mild Alzheimer's Disease, with stable medication for at least 3 months)
  • mild to moderate depression
  • corrected-to-normal hearing and vision
  • for MRI: non-magnetic metals inside the body
  • right handedness preferred

Exclusion Criteria:

  • cognitive impairment/ dementia with MMSE < 20, severe psychiatric or neurological disease (current and lifetime)
  • physical health that does not allow physical fitness tests and trainings
  • benzodiazepin, tricyclic antidepressants
  • for MRI: magnetic metal inside the body, cardiac pacemaker etc.
  • for liquor: insufficient blood coagulation, insufficient brain pressure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01061489

University of Konstanz
Konstanz, Germany, 78457
University of Ulm, Memory Clinic
Ulm, Germany, 89070
Sponsors and Collaborators
University of Konstanz
University of Ulm
Study Chair: Iris-Tatjana Kolassa, Prof. Dr. Clinical and Biological Psychology, University of Ulm

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Iris-Tatjana Kolassa, Prof. Dr. Iris-Tatjana Kolassa, University of Ulm Identifier: NCT01061489     History of Changes
Other Study ID Numbers: WIN-Kol-09
First Posted: February 3, 2010    Key Record Dates
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Iris-Tatjana Kolassa, University of Ulm:
Mild Cognitive Impairment (MCI)
sensory-cognitive training
physical fitness

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders