Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment
This study is currently recruiting participants.
Verified February 2012 by University of Konstanz
Sponsor:
University of Konstanz
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: February 21, 2012
Last verified: February 2012
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
Exercise and Physical Fitness
Mild Cognitive Impairment
U.S. FDA Resources
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 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061489
Contacts
| Contact: Franka Thurm, Dipl.-Psych. | 00497531884630 | franka.thurm@uni-konstanz.de |
| Contact: Küster Olivia, Dipl.-Psych. | 00497315026592 | olivia.kuester@uni-ulm.de |
Locations
| Germany | |
| University of Konstanz | Recruiting |
| Konstanz, Germany, 78457 | |
| Contact: Franka Glöckner, Dipl.-Psych. 00497531884630 franka.gloeckner@uni-konstanz.de | |
| University of Ulm, Memory Clinic | Recruiting |
| Ulm, Germany, 89070 | |
| Contact: Franka Glöckner, Dipl.-Psych. 00497531884630 franka.gloeckner@uni-konstanz.de | |
| Contact: Christine von Arnim, Prof. Dr. | |
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: | February 21, 2012 |
| 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:
|
Alzheimer Disease Cognition Disorders Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013