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Prevention of the Age-Related Cognitive Impairment by Exercise and Mental Activity - Berlin Bleibt Fit (BBF)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2008 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00629174
First Posted: March 5, 2008
Last Update Posted: March 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
German Research Foundation
Gertrude and Hugo Adler Foundation
Information provided by:
Charite University, Berlin, Germany
  Purpose
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.

Condition Intervention Phase
Cognition Mood Behavioral: Exercise Behavioral: Mental activity Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized, Controlled Study About the Effects of an Exercise Program and Mental Activity on the Age-Associated Impairment of Cognitive Function

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Improvement of cognitive and physical performance [ Time Frame: 6 months ]

Estimated Enrollment: 252
Study Start Date: June 2006
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Exercise
Behavioral: Exercise
Endurance and resistence training, 90 minutes, 3 times weekly
Experimental: 2
Mental training (computer lessons)
Behavioral: Mental activity
Participation at computer lessons, 3 times weekly, 90 minutes each
No Intervention: 3

Detailed Description:
Two-hundred and fifty-two women older than 70 years will be randomize to one of three groups. The first (exercise) will participate at an exercise program three times weekly for 90 minutes. The training will consist of an endurance and resistance training and will be carried out in a group. Participants in the second group (mental training) will take computer lessons, three times weekly for 90 minutes. Both interventions will be carried out for 26 weeks. Participants in the third group (control) will not participate at an structured intervention.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629174


Contacts
Contact: Fernando Dimeo, MD +49308445 ext 2098 fernando.dimeo@charite.de
Contact: Sarah Dauven sarah.dauven@charite.de

Locations
Germany
Section Sports Medicine, Charité - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 12200
Contact: Fernando Dimeo, PhD    +49308445 ext 2098    fernando.dimeo@charite.de   
Principal Investigator: Fernando C. Dimeo, PhD         
Department of Psychiatry Recruiting
Berlin, Germany, 14050
Contact: Isabella Heuser, Professor         
Principal Investigator: Isabella Heuser, Professor         
Principal Investigator: Friedel Reischies, Professor         
Sponsors and Collaborators
Charite University, Berlin, Germany
German Research Foundation
Gertrude and Hugo Adler Foundation
Investigators
Study Chair: 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
  More Information

Responsible Party: Prof. Isabella Heuser, Prof. Friedel Reischies, Dr. Fernando C. Dimeo, Charité - Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00629174     History of Changes
Other Study ID Numbers: 28_12_2005
First Submitted: February 25, 2008
First Posted: March 5, 2008
Last Update Posted: March 12, 2008
Last Verified: March 2008

Keywords provided by Charite University, Berlin, Germany:
Cognitive function
Elderly
Exercise
Mental activity