NCT01219231

Brief Summary

The researchers will investigate whether exercise could provide positive effects on general brain functions in elderly people with impaired glucose tolerance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

4.4 years

First QC Date

October 12, 2010

Last Update Submit

March 15, 2016

Conditions

Impaired Glucose Tolerance

Keywords

Exerciseelderlycognitionpreventioncognitive declineLifestyle

Outcome Measures

Primary Outcomes (1)

  • Auditory Verbal Learning Task

    Prior to intervention and after 6 months of intervention

Secondary Outcomes (2)

  • Functional/Structural brain changes

    Prior to intervention and after 6 months of intervention

  • Plasma biomarkers

    Prior to intervention and after 6 months of intervention

Study Arms (2)

Exercise

EXPERIMENTAL
Behavioral: Exercise

Placebo

PLACEBO COMPARATOR
Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

6 months of aerobic exercise

ExercisePlacebo

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects with impaired glucose tolerance
  • years old
  • moderate to heavy weight (BMI 25-35)
  • must be able to do exercise intervention

You may not qualify if:

  • diabetes
  • younger than 50 years
  • BMI \< 25
  • psychiatric medication
  • severe disease
  • MMSE \< 26
  • severe cardiovascular disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Charité Universitätsmedizin

Berlin, State of Berlin, Germany

Location

MeSH Terms

Conditions

Glucose IntoleranceMotor ActivityCognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesBehaviorCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Agnes Flöel, MD, Prof.

    Charité University Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

August 1, 2010

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

DE(1)