Physical Activity Training Program for Patients With Alzheimer's Dementia

NCT ID: NCT02196545

Last Updated: 2014-07-22

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to determine if a home based physical activity training program for patients with Alzheimer's dementia has effects on clinical and neurobiological parameters.

Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Exercise, patients train on a specifically programmed movement trainer three times a week for 30 minutes (total duration 12 weeks)

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Treatment as usual

Treatment according to guidelines of German Society for Psychiatry, Psychotherapy and Nervous Diseases (DGPPN) and German Society of Neurology (DGN) without movement trainer exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Intervention Type BEHAVIORAL

Other Intervention Names

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(RECK MotoMed®)

Eligibility Criteria

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Inclusion Criteria

* age \>55 years
* German is the dominant language (necessary for neuropsychological testing)
* minimum of 8 years formal school education
* caregiver (e.g. spouse) living at home with participant
* physical examination does not reveal contraindications to physical activity
* stable dose of pharmacological dementia treatment according to German guidelines (DGPPN) with acetylcholinesterase inhibitor or memantin or combination for at least 6 months
* no other medication that could influence cognitive functioning (e.g. benzodiazepines, sleep aids, neuroleptics)

Exclusion Criteria

* history of neurological or psychiatric disease other than AD
* history of substance abuse disorder
* history of electroconvulsive therapy (ECT) during the last 6 months
* structural brain deficits diagnosed in the MRI scan, also without clinical relevance (incidental finding)
* pacemaker, artificial heart valve, insulin pump or other medical implants
* average steps/day are above 10.000 steps/day
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RECK-Technik GmbH & Co. KG

UNKNOWN

Sponsor Role collaborator

Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vjera A Holthoff, Prof.

Role: PRINCIPAL_INVESTIGATOR

Technische Universität Dresden

Locations

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Technische Universität Dresden

Dresden, Saxony, Germany

Site Status

Countries

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Germany

References

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Holthoff VA, Marschner K, Scharf M, Steding J, Meyer S, Koch R, Donix M. Effects of physical activity training in patients with Alzheimer's dementia: results of a pilot RCT study. PLoS One. 2015 Apr 17;10(4):e0121478. doi: 10.1371/journal.pone.0121478. eCollection 2015.

Reference Type DERIVED
PMID: 25884637 (View on PubMed)

Other Identifiers

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MTDEM-001

Identifier Type: -

Identifier Source: org_study_id

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