Physical ActivityNCT03750812
The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions
A study testing Aerobic Exercise and Watching television in people with Physical Activity and Age-related Cognitive Decline, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
The proposed study is intended to examine the connection between two types of inhibition - cognitive and motor and the connection between motor inhibitory functions and a single bout of physical exercise in the context of age and physical fitness. Read more about this study
- Who is it for?
- Ages 22 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity, Age-related Cognitive Decline
- What is being tested?
- Aerobic Exercise and Watching television
- 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 siteIsrael
- Study dates
- Dec 2018to Dec 2020
- 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 22 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-smokers
- Do not take psychiatric drugs on a regular basis
- Geriatric Depression Scale score less than 3
- Mini-Mental State Examination score higher than 27
- Healthy and able to exercise at medium intensity
Who cannot join
- All others
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hille Yaffe Medical Center
Hadera
Eias Kassem, MD, eiask@hy.health.gov.il
About this study
The proposed study is intended to examine the connection between two types of inhibition - cognitive and motor and the connection between motor inhibitory functions and a single bout of physical exercise in the context of age and physical fitness.
- Conditions
- Physical Activity, Age-related Cognitive Decline
- Being tested
- Aerobic Exercise, Watching television
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
Medium-intense 60% heart rate reserve (HRR) aerobic exercise on a treadmill for 30 minutes
Watching televisionBehavioural
Sitting and watching television for 30 minutes
| Study group | Role | What they receive |
|---|---|---|
| Highly fit older adults - Exercise | Active comparator | This will receive an aerobic exercise intervention Receives: Behavioral: Aerobic Exercise |
| Poorly fit older adults - Exercise | Active comparator | This arm will receive an aerobic exercise intervention Receives: Behavioral: Aerobic Exercise |
| Highly fit young adults - Exercise | Active comparator | This arm will receive an aerobic exercise intervention Receives: Behavioral: Aerobic Exercise |
| Poorly fit young adults - Exercise | Active comparator | This arm will receive an aerobic exercise intervention Receives: Behavioral: Aerobic Exercise |
| Highly fit older adults - TV | Active comparator | This arm will sit at rest and watch television Receives: Behavioral: Watching television |
| Poorly fit older adults - TV | Active comparator | This arm will sit at rest and watch television Receives: Behavioral: Watching television |
| Highly fit young adults - TV | Active comparator | This arm will sit at rest and watch television Receives: Behavioral: Watching television |
| Poorly fit young adults - TV | Active comparator | This arm will sit at rest and watch television Receives: Behavioral: Watching television |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in cognitive functions after exercise
This improvement will be measured through use of a vocal stroop test
Measured: One and a half hours
Improvement in motor functions after exercise
This improvement will be measured through use of a multi-limb reaction time test
Measured: One and a half hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yael Netz, PhD, Study director, Wingate Academic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750812
- Sponsor's protocol ID
- HYMC-0065-18
- Status last verified
- Nov 2018
- First submitted
- 21 Nov 2018
- Last updated
- 23 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Age, Physical Fitness and a Single Bout of Aerobic Exercise on Motor and Cognitive Functions
- ClinicalTrials.gov ID
- NCT03750812
- Acronym / sponsor ID
- HYMC-0065-18
- Conditions
- Physical Activity, Age-related Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Dec 2018 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 23 Nov 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.
The proposed study is intended to examine the connection between two types of inhibition - cognitive and motor and the connection between motor inhibitory functions and a single bout of physical exercise in the context of age and physical fitness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Highly fit older adults - Exercise | Active comparator | Behavioral: Aerobic ExerciseThis will receive an aerobic exercise intervention |
| Poorly fit older adults - Exercise | Active comparator | Behavioral: Aerobic ExerciseThis arm will receive an aerobic exercise intervention |
| Highly fit young adults - Exercise | Active comparator | Behavioral: Aerobic ExerciseThis arm will receive an aerobic exercise intervention |
| Poorly fit young adults - Exercise | Active comparator | Behavioral: Aerobic ExerciseThis arm will receive an aerobic exercise intervention |
| Highly fit older adults - TV | Active comparator | Behavioral: Watching televisionThis arm will sit at rest and watch television |
| Poorly fit older adults - TV | Active comparator | Behavioral: Watching televisionThis arm will sit at rest and watch television |
| Highly fit young adults - TV | Active comparator | Behavioral: Watching televisionThis arm will sit at rest and watch television |
| Poorly fit young adults - TV | Active comparator | Behavioral: Watching televisionThis arm will sit at rest and watch television |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-smokers
- Do not take psychiatric drugs on a regular basis
- Geriatric Depression Scale score less than 3
- Mini-Mental State Examination score higher than 27
- Healthy and able to exercise at medium intensity
Key exclusion criteria (1 listed)
- All others
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 ExerciseMedium-intense 60% heart rate reserve (HRR) aerobic exercise on a treadmill for 30 minutes | Behavioural | Highly fit older adults - Exercise, Highly fit young adults - Exercise, Poorly fit older adults - Exercise, Poorly fit young adults - Exercise |
| Watching televisionSitting and watching television for 30 minutes | Behavioural | Highly fit older adults - TV, Highly fit young adults - TV, Poorly fit older adults - TV, Poorly fit young adults - TV |
Primary outcome
Improvement in cognitive functions after exercise
Time frame: One and a half hours
This improvement will be measured through use of a vocal stroop test
Improvement in motor functions after exercise
Time frame: One and a half hours
This improvement will be measured through use of a multi-limb reaction time test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Yael Netz, PhD study director
Wingate Academic Institute
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 and Watching television in people with Physical Activity and Age-related 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 5 inclusion and 1 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 23 Nov 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?
Contact Mona Abu-Rukun, MA (972-54-5343199, mona1986ar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in cognitive functions after exercise (time frame: One and a half hours). 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 23 Nov 2018.