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

NCT ID: NCT00629174

Last Updated: 2008-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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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

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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.

Conditions

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Cognition Mood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Endurance and resistence training, 90 minutes, 3 times weekly

2

Mental training (computer lessons)

Group Type EXPERIMENTAL

Mental activity

Intervention Type BEHAVIORAL

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

3

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

Endurance and resistence training, 90 minutes, 3 times weekly

Intervention Type BEHAVIORAL

Mental activity

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Gertrude and Hugo Adler Foundation

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Charité - Universitätsmedizin Berlin

Principal Investigators

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Isabella Heuser, Professor

Role: STUDY_CHAIR

Charite University, Berlin, Germany

Fernando C Dimeo, PhD

Role: STUDY_CHAIR

Charite University, Berlin, Germany

Friedel Reischies, Professor

Role: STUDY_CHAIR

Charite University, Berlin, Germany

Locations

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Section Sports Medicine, Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status RECRUITING

Department of Psychiatry

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Fernando Dimeo, MD

Role: CONTACT

+49308445 ext. 2098

Sarah Dauven

Role: CONTACT

Facility Contacts

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Fernando Dimeo, PhD

Role: primary

+49308445 ext. 2098

Isabella Heuser, Professor

Role: primary

Other Identifiers

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28_12_2005

Identifier Type: -

Identifier Source: org_study_id

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