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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2008 by Charite University, Berlin, Germany.
Recruitment status was Recruiting

Sponsor:

Collaborators:

German Research Foundation

Gertrude and Hugo Adler Foundation

Information provided by:

Charite University, Berlin, Germany

ClinicalTrials.gov Identifier:

NCT00629174

First received: February 25, 2008

Last updated: March 11, 2008

Last verified: March 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

February 25, 2008

Last Updated Date

March 11, 2008

Start Date ^ICMJE

June 2006

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Improvement of cognitive and physical performance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00629174 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Randomized, Controlled Study About the Effects of an Exercise Program and Mental Activity on the Age-Associated Impairment of Cognitive Function

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Cognition
Mood

Intervention ^ICMJE

Behavioral: Exercise
Endurance and resistence training, 90 minutes, 3 times weekly
Behavioral: Mental activity
Participation at computer lessons, 3 times weekly, 90 minutes each

Study Arm (s)

Experimental: 1
Exercise

Intervention: Behavioral: Exercise
Experimental: 2
Mental training (computer lessons)

Intervention: Behavioral: Mental activity
No Intervention: 3

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

252

Completion Date

Not Provided

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

70 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00629174

Other Study ID Numbers ^ICMJE

28_12_2005

Has Data Monitoring Committee

Responsible Party

Prof. Isabella Heuser, Prof. Friedel Reischies, Dr. Fernando C. Dimeo, Charité - Universitätsmedizin Berlin

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

German Research Foundation
Gertrude and Hugo Adler Foundation

Investigators ^ICMJE

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

Information Provided By

Charite University, Berlin, Germany

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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