CognitionPhase 3BBFNCT00629174
Prevention of the Age-Related Cognitive Impairment by Exercise and Mental Activity - Berlin Bleibt Fit
A Phase 3 study testing Exercise and Mental activity in people with Cognition and Mood, run by Charite University, Berlin, Germany at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 70 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Exercise and Mental activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2006to Dec 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- All healthy women older than 70 years with sufficient knowledge of German can participate.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Sarah Dauven contact
Germany2 sites, 2 recruiting
- Recruiting
Section Sports Medicine, Charité - Universitätsmedizin Berlin
Berlin, 12200
Fernando Dimeo, PhD, +49308445 ext. 2098, fernando.dimeo@charite.de
Fernando C. Dimeo, PhD
- Recruiting
Department of Psychiatry
Berlin, 14050
Isabella Heuser, Professor
Isabella Heuser, Professor
About this study
Official title: 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.
Read the 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.
- Being tested
- Exercise, Mental activity
- Keywords
- Cognitive function, Elderly, Exercise, Mental activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Endurance and resistence training, 90 minutes, 3 times weekly
Mental activityBehavioural
Participation at computer lessons, 3 times weekly, 90 minutes each
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Exercise Receives: Behavioral: Exercise |
| 2 | Experimental | Mental training (computer lessons) Receives: Behavioral: Mental activity |
| 3 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of cognitive and physical performance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJun 2006
- Primary completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, Gertrude and Hugo Adler Foundation
- Investigators
- Isabella Heuser, Professor, Study chair, Charite University, Berlin, GermanyFernando C Dimeo, PhD, Study chair, Charite University, Berlin, GermanyFriedel Reischies, Professor, Study chair, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629174
- Sponsor's protocol ID
- 28_12_2005
- Acronym
- BBF
- Status last verified
- Mar 2008
- First submitted
- 25 Feb 2008
- Last updated
- 12 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Study About the Effects of an Exercise Program and Mental Activity on the Age-Associated Impairment of Cognitive Function
- ClinicalTrials.gov ID
- NCT00629174
- Acronym / sponsor ID
- BBF / 28_12_2005
- Keywords
- Cognitive function, Elderly, Exercise, Mental activity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation, Gertrude and Hugo Adler Foundation
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (estimated)
- First posted
- 5 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: ExerciseExercise |
| 2 | Experimental | Behavioral: Mental activityMental training (computer lessons) |
| 3 | No intervention | – |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- All healthy women older than 70 years with sufficient knowledge of German can participate.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseEndurance and resistence training, 90 minutes, 3 times weekly | Behavioural | 1 |
| Mental activityParticipation at computer lessons, 3 times weekly, 90 minutes each | Behavioural | 2 |
Primary outcome
Improvement of cognitive and physical performance
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Dauven contact
Isabella Heuser, Professor study chair
Charite University, Berlin, Germany
Fernando C Dimeo, PhD study chair
Charite University, Berlin, Germany
Friedel Reischies, Professor study chair
Charite University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exercise and Mental activity in people with Cognition and Mood, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fernando Dimeo, MD (+49308445 ext. 2098, fernando.dimeo@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of cognitive and physical performance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2008.