AgingNCT03420365
The Effect of a Single Bout of Balance and Coordination Exercise on Cognitive Function in Elderly People
A study testing Aerobic exercise in people with Aging and Cognitive Decline, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Individuals of advanced age are at higher risk of cognitive deterioration.A single bout of aerobic exercise was found to improve cognitive functions. The aim of this study is to explore the effect of a single bout of balance and coordination exercise versus aerobic exercise on cognitive functions among elderly people. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Cognitive Decline
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2018to Jul 2019
- Phase
- Interventional
- 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
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to undergo physical activity for 60 minutes
- Participates in a physical activity center at least twice a week
Who cannot join
- Scores beneath 24 on MMSE
- Unable to sign a consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Single Bout of Aerobic Exercise Versus a Single Bout of Balance and Coordination Exercise on Cognitive Function in Elderly People
Individuals of advanced age are at higher risk of cognitive deterioration.A single bout of aerobic exercise was found to improve cognitive functions. The aim of this study is to explore the effect of a single bout of balance and coordination exercise versus aerobic exercise on cognitive functions among elderly people.
- Conditions
- Aging, Cognitive Decline
- Being tested
- Aerobic exercise
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Also called Balance and coordination exercise, Control
30 minutes of either aerobic, or balance and coordination, or reading magazines
| Study group | Role | What they receive |
|---|---|---|
| Type of intervention | Experimental | A single bout of aerobic exercise, or a single bout of balance and coordination exercise, or reading a magazine Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function - Attention
This cognitive domain will be based on scores of two tests: Go-NoGo test and the Stroop test, which will be performed by the use of NeuroTrax (NeuroTrax Corp., Israel) computerized battery that utilizes novel adaptations of traditional neuropsychological tests. In order to assess attention the mean reaction times (RTs) for the Go-NoGo test and the no-interference (meaning) phase of the Stroop test, and mean SD of RT for the Go-NoGo test will be calculated.
Measured: Each cognitive test will be performed immediately following the intervention
Cognitive function - Executive functions
This cognitive domain will be based on scores of three tests: Go-NoGo test, Catch game and the Stroop test, which will be performed by the use of NeuroTrax (NeuroTrax Corp., Israel) computerized battery that utilizes novel adaptations of traditional neuropsychological tests. In order to assess executive function Performance indices for the Stroop test and the Go-NoGo test, and mean accuracy for the Catch Game will be calculated.
Measured: Each cognitive test will be performed immediately following the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startFeb 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- The Academic College at Wingate, Israel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420365
- Sponsor's protocol ID
- HYMC-0136-17
- Status last verified
- Jan 2018
- First submitted
- 17 Jan 2018
- Last updated
- 5 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study Protocol Statistical Analysis Plan
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Bout of Aerobic Exercise Versus a Single Bout of Balance and Coordination Exercise on Cognitive Function in Elderly People
- ClinicalTrials.gov ID
- NCT03420365
- Acronym / sponsor ID
- HYMC-0136-17
- Conditions
- Aging, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- The Academic College at Wingate, Israel
- Study start
- Feb 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 5 Feb 2018 (actual)
- 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.
Individuals of advanced age are at higher risk of cognitive deterioration.A single bout of aerobic exercise was found to improve cognitive functions. The aim of this study is to explore the effect of a single bout of balance and coordination exercise versus aerobic exercise on cognitive functions among elderly people.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type of intervention | Experimental | Behavioral: Aerobic exerciseA single bout of aerobic exercise, or a single bout of balance and coordination exercise, or reading a magazine |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Able to undergo physical activity for 60 minutes
- Participates in a physical activity center at least twice a week
Key exclusion criteria (2 listed)
- Scores beneath 24 on MMSE
- Unable to sign a consent form
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 exerciseAlso: Balance and coordination exercise, Control30 minutes of either aerobic, or balance and coordination, or reading magazines | Behavioural | Type of intervention |
Primary outcome
Cognitive function - Attention
Time frame: Each cognitive test will be performed immediately following the intervention
This cognitive domain will be based on scores of two tests: Go-NoGo test and the Stroop test, which will be performed by the use of NeuroTrax (NeuroTrax Corp., Israel) computerized battery that utilizes novel adaptations of traditional neuropsychological tests. In order to assess attention the mean reaction times (RTs) for the Go-NoGo test and the no-interference (meaning) phase of the Stroop test, and mean SD of RT for the Go-NoGo test will be calculated.
Cognitive function - Executive functions
Time frame: Each cognitive test will be performed immediately following the intervention
This cognitive domain will be based on scores of three tests: Go-NoGo test, Catch game and the Stroop test, which will be performed by the use of NeuroTrax (NeuroTrax Corp., Israel) computerized battery that utilizes novel adaptations of traditional neuropsychological tests. In order to assess executive function Performance indices for the Stroop test and the Go-NoGo test, and mean accuracy for the Catch Game will be calculated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Individual participant dataSharing planned: Undecided. Study Protocol Statistical Analysis Plan
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Aging and Cognitive Decline, 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 2 inclusion and 2 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 5 Feb 2018. 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.
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?
Cognitive function - Attention (time frame: Each cognitive test will be performed immediately following the intervention). The study lists 2 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 5 Feb 2018.