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

March 11, 2008 updated by: Charite University, Berlin, Germany

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

252

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 12200
        • Recruiting
        • Section Sports Medicine, Charité - Universitätsmedizin Berlin
        • Contact:
        • Principal Investigator:
          • Fernando C. Dimeo, PhD
      • Berlin, Germany, 14050
        • Recruiting
        • Department of Psychiatry
        • Contact:
          • Isabella Heuser, Professor
        • Principal Investigator:
          • Isabella Heuser, Professor
        • Principal Investigator:
          • Friedel Reischies, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 3
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improvement of cognitive and physical performance
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

February 25, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (Estimate)

March 5, 2008

Study Record Updates

Last Update Posted (Estimate)

March 12, 2008

Last Update Submitted That Met QC Criteria

March 11, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 28_12_2005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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