Back to resultsSensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment (MCI), Mild Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
auditory discrimination training
physical movement training
Sponsored by
About this trial
This is an interventional treatment trial for Mild Cognitive Impairment (MCI) focused on measuring neuroplasticity, Mild Cognitive Impairment (MCI), Alzheimer, sensory-cognitive training, physical fitness
Eligibility Criteria
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
Sites / Locations
- University of Konstanz
- University of Ulm, Memory Clinic
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
sensory-cognitive training
physical fitness
waiting list (control group)
Arm Description
Outcomes
Primary Outcome Measures
Change in global cognition
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
electrophysiological, MRI, blood and liquor correlates
Full Information
NCT ID
NCT01061489
First Posted
February 2, 2010
Last Updated
July 13, 2016
Sponsor
University of Konstanz
Collaborators
University of Ulm
1. Study Identification
Unique Protocol Identification Number
NCT01061489
Brief Title
Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment
Official Title
Computer-based Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment (MCI) and Mild Alzheimer's Disease (AD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
University of Ulm
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment (MCI), Mild Alzheimer's Disease
Keywords
neuroplasticity, Mild Cognitive Impairment (MCI), Alzheimer, sensory-cognitive training, physical fitness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sensory-cognitive training
Arm Type
Experimental
Arm Title
physical fitness
Arm Type
Experimental
Arm Title
waiting list (control group)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
auditory discrimination training
Intervention Description
10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home
Intervention Type
Other
Intervention Name(s)
physical movement training
Intervention Description
10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week)
Primary Outcome Measure Information:
Title
Change in global cognition
Description
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).
Time Frame
pre, post, 3-month follow-up
Secondary Outcome Measure Information:
Title
electrophysiological, MRI, blood and liquor correlates
Time Frame
pre, post, 3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris-Tatjana Kolassa, Prof. Dr.
Organizational Affiliation
Clinical and Biological Psychology, University of Ulm
Official's Role
Study Chair
Facility Information:
Facility Name
University of Konstanz
City
Konstanz
ZIP/Postal Code
78457
Country
Germany
Facility Name
University of Ulm, Memory Clinic
City
Ulm
ZIP/Postal Code
89070
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
27608620
Citation
Kuster OC, Fissler P, Laptinskaya D, Thurm F, Scharpf A, Woll A, Kolassa S, Kramer AF, Elbert T, von Arnim CA, Kolassa IT. Cognitive change is more positively associated with an active lifestyle than with training interventions in older adults at risk of dementia: a controlled interventional clinical trial. BMC Psychiatry. 2016 Sep 8;16(1):315. doi: 10.1186/s12888-016-1018-z.
Results Reference
derived
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Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment
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