Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment

July 13, 2016 updated by: Iris-Tatjana Kolassa, University of Konstanz

Computer-based Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

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
      • Konstanz, Germany, 78457
        • University of Konstanz
      • Ulm, Germany, 89070
        • University of Ulm, Memory Clinic

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:

  • 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

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
pre, post, 3-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
electrophysiological, MRI, blood and liquor correlates
Time Frame: pre, post, 3-month follow-up
pre, post, 3-month follow-up

Collaborators and Investigators

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

Sponsor

University of Konstanz

Collaborators

University of Ulm

Investigators

  • Study Chair: Iris-Tatjana Kolassa, Prof. Dr., Clinical and Biological Psychology, University of Ulm

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, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIN-Kol-09

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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