Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 25, 2008
March 11, 2008
June 2006
December 2008   (final data collection date for primary outcome measure)
Improvement of cognitive and physical performance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00629174 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Prevention of the Age-Related Cognitive Impairment by Exercise and Mental Activity - Berlin Bleibt Fit
Randomized, Controlled Study About the Effects of an Exercise Program and Mental Activity on the Age-Associated Impairment of Cognitive Function

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Cognition
  • Mood
  • Behavioral: Exercise
    Endurance and resistence training, 90 minutes, 3 times weekly
  • Behavioral: Mental activity
    Participation at computer lessons, 3 times weekly, 90 minutes each
  • Experimental: 1
    Exercise
    Intervention: Behavioral: Exercise
  • Experimental: 2
    Mental training (computer lessons)
    Intervention: Behavioral: Mental activity
  • No Intervention: 3
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
252
Not Provided
December 2008   (final data collection date for primary outcome measure)

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
Female
70 Years and older
Yes
Contact: Fernando Dimeo, MD +49308445 ext 2098 fernando.dimeo@charite.de
Contact: Sarah Dauven sarah.dauven@charite.de
Germany
 
NCT00629174
28_12_2005
No
Prof. Isabella Heuser, Prof. Friedel Reischies, Dr. Fernando C. Dimeo, Charité - Universitätsmedizin Berlin
Charite University, Berlin, Germany
  • German Research Foundation
  • Gertrude and Hugo Adler Foundation
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
Charite University, Berlin, Germany
March 2008

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