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

Cognition Clinical Trial

— BBF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00629174
• Other study ID #: 28_12_2005
• Status: Recruiting
• Phase: Phase 3
• First received: February 25, 2008
• Last updated: March 11, 2008
• Start date: June 2006

Study information

• Verified date: March 2008
• Source: Charite University, Berlin, Germany
• Contact: Fernando Dimeo, MD
• Phone: +49308445
• Email: fernando.dimeo[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 252
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 70 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cognition
• Mood

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Psychiatry	Berlin
Germany	Section Sports Medicine, Charité - Universitätsmedizin Berlin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Research Foundation, Gertrude and Hugo Adler Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of cognitive and physical performance		6 months	No