Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment

This study has been completed.
Sponsor:
Collaborator:
University of Ulm
Information provided by (Responsible Party):
Iris-Tatjana Kolassa, University of Ulm
ClinicalTrials.gov Identifier:
NCT01061489
First received: February 2, 2010
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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 > 21). Evaluation will include neuropsychological testing, electroencephalography (EEG) and magnetic resonance imaging (MRI) measurements as well as blood and liquor analyses.


Condition Intervention
Mild Cognitive Impairment (MCI)
Mild Alzheimer's Disease
Other: auditory discrimination training
Other: physical movement training

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by University of Konstanz:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-Cog) [ Time Frame: pre, post, 3-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • electrophysiological, blood and liquor correlates [ Time Frame: pre, post, 3-month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2009
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • focus: subjective and/or objective memory complaints with MMSE > 21 (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 < 22, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061489

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

Additional Information:
No publications provided

Responsible Party: Iris-Tatjana Kolassa, Prof. Dr. Iris-Tatjana Kolassa, University of Ulm
ClinicalTrials.gov Identifier: NCT01061489     History of Changes
Other Study ID Numbers: WIN-Kol-09
Study First Received: February 2, 2010
Last Updated: November 26, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University of Konstanz:
neuroplasticity
Mild Cognitive Impairment (MCI)
Alzheimer
sensory-cognitive training
physical fitness

Additional relevant MeSH terms:
Mild Cognitive Impairment
Alzheimer Disease
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 16, 2014