Aerobic ExercisePhase 3NCT01475396
The Effect of Physical Activity on the Brain
A Phase 3 study testing exercise in people with Aerobic Exercise and Anaerobic Exercise, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Physical activity is thought to increase overall body functions and to decrease cardiovascular and stroke risk factors. Now the question arose, wether enhanced exercise could also exert positive influence on cognition in the aging brain. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aerobic Exercise, Anaerobic Exercise, Unchanged Condition
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Dec 2012
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-80 years old
- healthy
- lesser activity
Who cannot join
- regular physical activity
- diabetes
- stroke
- heavy smoking, drinking,
- BMI < 20
- MMSE < 25
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Muenster
Münster, North Rhine-Westphalia, 48149
About this study
Official title: Clinical Study on the Effect of Physical Activity on Cognition and Memory in the Elderly
Physical activity is thought to increase overall body functions and to decrease cardiovascular and stroke risk factors. Now the question arose, wether enhanced exercise could also exert positive influence on cognition in the aging brain. Therefore, 50 to 80 years old healthy subjects take part in a prospective study with regular sports activity during 6 months. Cognitive functions are detected with sensitive neuropsychological outcome measures, further investigations include MRT of the head, lactat- and other physical measures as well as detailed serum profiles. As a hypothesis, enhanced physical activity is suggested to predict better cognitive performance.
- Conditions
- Aerobic Exercise, Anaerobic Exercise, Unchanged Condition
- Being tested
- exercise
- Keywords
- exercise, physical activity, cognition, brain, aging, BDNF
- 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
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise | Experimental | Not described Receives: Behavioral: exercise |
| Anaerobic Exercise | Experimental | Not described Receives: Behavioral: exercise |
| Unchanged condition | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition
Measured: 6 months
Change of delayed memory scores in #of words in a Verbal learning task after 6 months of intervention/control condition
Measured: 6 months
Change of performance in ms in a reaction time task after 6 months of intervention/control condition
Measured: 6 months
Change of relative regional grey matter volumes in % measured by T1-weighted MRI after 6 months of intervention/control condition
Measured: 6 months
Secondary outcomes (2)
Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition
Measured: 6 months
Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition
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 posted21 Nov 2011 (estimated)
- Study startMar 2006
- Primary completionMar 2012
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aerobic ExerciseStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Sponsor
- Investigators
- Agnes Flooel, MD, Principal investigator, University Hospital of MuensterStefan Knecht, MD, Study director, University Hospital of Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01475396
- Sponsor's protocol ID
- Exercise_Neuromod
- Status last verified
- Jun 2012
- First submitted
- 7 Nov 2011
- Last updated
- 19 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Effect of Physical Activity on Cognition and Memory in the Elderly
- ClinicalTrials.gov ID
- NCT01475396
- Acronym / sponsor ID
- Exercise_Neuromod
- Conditions
- Aerobic Exercise, Anaerobic Exercise, Unchanged Condition
- Keywords
- exercise, physical activity, cognition, brain, aging, BDNF
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Mar 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Dec 2012 (estimated)
- First posted
- 21 Nov 2011 (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.
Physical activity is thought to increase overall body functions and to decrease cardiovascular and stroke risk factors. Now the question arose, wether enhanced exercise could also exert positive influence on cognition in the aging brain. Therefore, 50 to 80 years old healthy subjects take part in a prospective study with regular sports activity during 6 months. Cognitive functions are detected with sensitive neuropsychological outcome measures, further investigations include MRT of the head, lactat- and other physical measures as well as detailed serum profiles. As a hypothesis, enhanced physical activity is suggested to predict better cognitive performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise | Experimental | Behavioral: exercise |
| Anaerobic Exercise | Experimental | Behavioral: exercise |
| Unchanged condition | No intervention | – |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50-80 years old
- healthy
- lesser activity
Key exclusion criteria (6 listed)
- regular physical activity
- diabetes
- stroke
- heavy smoking, drinking,
- BMI < 20
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 |
|---|---|---|
| exercise | Behavioural | Aerobic Exercise, Anaerobic Exercise |
Primary outcome
Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition
Time frame: 6 months
Change of delayed memory scores in #of words in a Verbal learning task after 6 months of intervention/control condition
Time frame: 6 months
Change of performance in ms in a reaction time task after 6 months of intervention/control condition
Time frame: 6 months
Change of relative regional grey matter volumes in % measured by T1-weighted MRI after 6 months of intervention/control condition
Time frame: 6 months
2 secondary outcomes
Change of physical measurements (ECG)/fitness assessments (lactate) after 6 months of intervention/control condition
Time frame: 6 months
Change of BDNF blood serum levels in ng/dl after 6 months of intervention/control condition
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 19 Jun 2012.
Related trials for Aerobic Exercise
Recruiting
Evaluating the Feasibility of Prehabilitation Delivery Models for Patients Preparing for Gynecologic Cancer Surgery
Prehabilitation, Preoperative Aerobic Training
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruiting
Blood Parameter Changes Following Aerobic Exercise in Professional Soccer Players
Exercise Physiology, Blood Parameters
Recruiting
Acute Endocrine Responses to Aerobic and Anaerobic Exercise in Sedentary Women: A Comparative Analysis of Thyroid Hormones and Cortisol
Sedentary Behavior, Acute Exercise
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.
Agnes Flooel, MD principal investigator
University Hospital of Muenster
Stefan Knecht, MD study director
University Hospital of Muenster
1 site 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 in people with Aerobic Exercise and Anaerobic Exercise, run by University Hospital Muenster at 1 site 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 3 inclusion and 6 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 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of reaction times in ms in a motor learning task after 6 months of intervention/control condition (time frame: 6 months). The study lists 4 primary outcomes in all. 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 19 Jun 2012.