Cognitive Function in ElderlyEarly Phase 1NCT01241851
Effect of Acute Exercise on Cognitive Functions
A Early Phase 1 study testing Aerobic exercise and Resistance exercise in people with Cognitive Function in Elderly, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
To determine whether acute aerobic exercise versus resistance exercise effects cognitive function among older adults. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function in Elderly
- What is being tested?
- Aerobic exercise and Resistance exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Dec 2011
- Phase
- Early Phase 1
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Exercise at least 2 times a week Able to sign informed consent Able to perform ergometric exam Above 40 years old
Who cannot join
- Smoking
- Suffering psychiatric or neurologic illness
- No medication for chronic illness that could effect cognitive function
- Problems with cognitive functioning after head trauma
- Long-term hospitalization within the past 3 months
- Inability to use computer because of vision or motor problems
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Israel1 site
Zinman College, Wingate Institute
Netanya
Netz, neyael@wincol.ac.il
About this study
To determine whether acute aerobic exercise versus resistance exercise effects cognitive function among older adults.
- Conditions
- Cognitive Function in Elderly
- Being tested
- Aerobic exercise, Resistance exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Resistance exerciseBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Active comparator | Not described Receives: Behavioral: Aerobic exercise |
| Resistance exercise | Active comparator | Not described Receives: Behavioral: Resistance exercise |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of executive function
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Function in ElderlyStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- The Zinman College for Physical Education and Sport Exercise, Wingate Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241851
- Sponsor's protocol ID
- 0093-10-HYMC
- Status last verified
- Nov 2010
- First submitted
- 15 Nov 2010
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acute Exercise on Cognitive Functions
- ClinicalTrials.gov ID
- NCT01241851
- Acronym / sponsor ID
- 0093-10-HYMC
- Conditions
- Cognitive Function in Elderly
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- The Zinman College for Physical Education and Sport Exercise, Wingate Institute
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Nov 2010 (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.
To determine whether acute aerobic exercise versus resistance exercise effects cognitive function among older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Active comparator | Behavioral: Aerobic exercise |
| Resistance exercise | Active comparator | Behavioral: Resistance exercise |
| Control | No intervention | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Exercise at least 2 times a week Able to sign informed consent Able to perform ergometric exam Above 40 years old
Key exclusion criteria (7 listed)
- Smoking
- Suffering psychiatric or neurologic illness
- No medication for chronic illness that could effect cognitive function
- Problems with cognitive functioning after head trauma
- Long-term hospitalization within the past 3 months
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 |
|---|---|---|
| Aerobic exercise | Behavioural | Aerobic exercise |
| Resistance exercise | Behavioural | Resistance exercise |
Primary outcome
Level of executive function
Time frame: One month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aerobic exercise and Resistance exercise in people with Cognitive Function in Elderly, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 7 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 16 Nov 2010. 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 Israel. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Yael Netz, PhD (972-9-8639362, neyael@wincol.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of executive function (time frame: One month). 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 16 Nov 2010.