NCT00629174

Brief Summary

The trial will evaluate the effects of frequent exercise and increased mental activity on the age-related impairment of cognitive function in elderly women. Furthermore, we will assess the effects of exercise and mental activity on the mood, physical performance and mental status of participants. We will also search for genetic factors which may be responsible of the observed outcomes.

Trial Health

55
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Trial Health Score

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

Enrollment
252

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

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

June 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Last Updated

March 12, 2008

Status Verified

March 1, 2008

Enrollment Period

2.5 years

First QC Date

February 25, 2008

Last Update Submit

March 11, 2008

Conditions

CognitionMood

Keywords

Cognitive functionElderlyExerciseMental activity

Outcome Measures

Primary Outcomes (1)

  • Improvement of cognitive and physical performance

    6 months

Study Arms (3)

1

EXPERIMENTAL

Exercise

Behavioral: Exercise

2

EXPERIMENTAL

Mental training (computer lessons)

Behavioral: Mental activity

3

NO INTERVENTION

Interventions

ExerciseBEHAVIORAL

Endurance and resistence training, 90 minutes, 3 times weekly

1
Mental activityBEHAVIORAL

Participation at computer lessons, 3 times weekly, 90 minutes each

2

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • All healthy women older than 70 years with sufficient knowledge of German can participate.

You may not qualify if:

  • Chronic mental disorders
  • Chronic neurological, cardiological, pulmonary or renal diseases.
  • Severe osteoarthritis
  • Disorders which can be aggravated by exercise (arterial hypertension, coronary heart disease, COLD).
  • Cancer in current therapy
  • Treatment with glucocorticoids or cytostatic drugs.
  • Patients who received an organ transplantation
  • Exercise-induced osteoarticular pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Section Sports Medicine, Charité - Universitätsmedizin Berlin

Berlin, 12200, Germany

RECRUITING

Department of Psychiatry

Berlin, 14050, Germany

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Isabella Heuser, Professor

    Charite University, Berlin, Germany

    STUDY CHAIR

  • Fernando C Dimeo, PhD

    Charite University, Berlin, Germany

    STUDY CHAIR

  • Friedel Reischies, Professor

    Charite University, Berlin, Germany

    STUDY CHAIR

Central Study Contacts

Fernando Dimeo, MD

CONTACT

+49308445fernando.dimeo@charite.de

Sarah Dauven

CONTACT

sarah.dauven@charite.de

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 5, 2008

Study Start

June 1, 2006

Primary Completion

December 1, 2008

Last Updated

March 12, 2008

Record last verified: 2008-03

Locations

DE(2)