NCT01475396

Brief Summary

Physical activity is thought to increase overall body functions and to decrease cardiovascular and stroke risk factors. Now the question arose, wether enhanced exercise could also exert positive influence on cognition in the aging brain. Therefore, 50 to 80 years old healthy subjects take part in a prospective study with regular sports activity during 6 months. Cognitive functions are detected with sensitive neuropsychological outcome measures, further investigations include MRT of the head, lactat- and other physical measures as well as detailed serum profiles. As a hypothesis, enhanced physical activity is suggested to predict better cognitive performance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2006

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

6 years

First QC Date

November 7, 2011

Last Update Submit

June 18, 2012

Conditions

Aerobic ExerciseAnaerobic ExerciseUnchanged Condition

Keywords

exercisephysical activitycognitionbrainagingBDNF

Outcome Measures

Primary Outcomes (4)

  • Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition

    6 months

  • Change of delayed memory scores in #of words in a Verbal learning task after 6 months of intervention/control condition

    6 months

  • Change of performance in ms in a reaction time task after 6 months of intervention/control condition

    6 months

  • Change of relative regional grey matter volumes in % measured by T1-weighted MRI after 6 months of intervention/control condition

    6 months

Secondary Outcomes (2)

  • Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition

    6 months

  • Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition

    6 months

Study Arms (3)

Aerobic Exercise

EXPERIMENTAL
Behavioral: exercise

Anaerobic Exercise

EXPERIMENTAL
Behavioral: exercise

Unchanged condition

NO INTERVENTION

Interventions

exerciseBEHAVIORAL
Aerobic ExerciseAnaerobic Exercise

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • healthy
  • lesser activity

You may not qualify if:

  • regular physical activity
  • diabetes
  • stroke
  • heavy smoking, drinking,
  • BMI \< 20
  • MMSE \< 25

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Agnes Flooel, MD

    University Hospital of Muenster

    PRINCIPAL INVESTIGATOR

  • Stefan Knecht, MD

    University Hospital of Muenster

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2011

First Posted

November 21, 2011

Study Start

March 1, 2006

Primary Completion

March 1, 2012

Study Completion

December 1, 2012

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

DE(1)