NCT02196545

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 14, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
Last Updated

July 22, 2014

Status Verified

July 1, 2014

Enrollment Period

1.9 years

First QC Date

July 14, 2014

Last Update Submit

July 18, 2014

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

  • activities of daily living

    Alzheimer's Disease Cooperative Study/Activities of Daily Living (ADCS/ADL)

    change from baseline after 12 weeks

Secondary Outcomes (6)

  • behavioral symptoms of dementia

    change from baseline after 12 weeks and 24 weeks

  • cognition

    change from baseline after 12 weeks and 24 weeks

  • executive function and language ability

    change from baseline after 12 weeks and 24 weeks

  • caregiver burden

    change from baseline after 12 weeks and 24 weeks

  • Reaction time, hand-eye quickness and attention

    change from baseline after 12 weeks and 24 weeks

  • +1 more secondary outcomes

Other Outcomes (1)

  • hippocampal cortical thickness

    change from baseline after 12 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

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

Behavioral: Exercise

Treatment as usual

NO INTERVENTION

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

Interventions

ExerciseBEHAVIORAL
Also known as: (RECK MotoMed®)
Exercise

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität Dresden

Dresden, Saxony, 01307, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25884637DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Vjera A Holthoff, Prof.

    Technische Universität Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2014

First Posted

July 22, 2014

Study Start

August 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 22, 2014

Record last verified: 2014-07

Locations

DE(1)