Sensory-cognitive and Physical Fitness Training in Mild Cognitive Impairment

NCT ID: NCT01061489

Last Updated: 2016-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment (MCI) Mild Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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sensory-cognitive training

Group Type EXPERIMENTAL

auditory discrimination training

Intervention Type OTHER

10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home

physical fitness

Group Type EXPERIMENTAL

physical movement training

Intervention Type OTHER

10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week)

waiting list (control group)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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auditory discrimination training

10-week neuroplasticity-based training (5 days/week, 1 hour each, PC-based), training at home

Intervention Type OTHER

physical movement training

10-week training, small groups (2 days/week, 1 hour each) plus homework (3 days/week)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role collaborator

University of Konstanz

OTHER

Sponsor Role lead

Responsible Party

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Iris-Tatjana Kolassa

Prof. Dr. Iris-Tatjana Kolassa

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Iris-Tatjana Kolassa, Prof. Dr.

Role: STUDY_CHAIR

Clinical and Biological Psychology, University of Ulm

Locations

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University of Konstanz

Konstanz, , Germany

Site Status

University of Ulm, Memory Clinic

Ulm, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 27608620 (View on PubMed)

Related Links

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Other Identifiers

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WIN-Kol-09

Identifier Type: -

Identifier Source: org_study_id

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