AgingNCT06068374
Breaks From Sedentary Behavior With Dual Tasks in Elderly
A study testing Break of sedentary behavior with dual task and Break of sedentary behavior with walking in people with Aging, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The aim of this project will be to compare the acute effects of breaks from sedentary behavior using dual-tasking on cerebral blood flow, vascular function, cognitive functions and blood pressure in elderly people. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Break of sedentary behavior with dual task and Break of sedentary behavior with walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Feb 2023to 31 Jul 2024
- 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 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 60 years or over
- be physically independent based on the Katz Test
- have no history of heart attack
- not having suffered a stroke
- not have heart failure
- do not have joint problems that prevent them from carrying out experimental sessions
Show all 10Show fewer
- do not have a history of neurodegenerative diseases
- obtain ≥ 26 points in the Montreal Cognitive Assessment (MoCA)
- are not involved in the practice of regular, systematic physical activity more than once a week over the last six months prior to the start of the study
- not be smokers and morbidly obese.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Breaks From Sedentary Behavior With Dual Tasks on Cerebral Blood Flow, Cognitive Function, Blood Pressure and Vascular Function in the Elderly
The aim of this project will be to compare the acute effects of breaks from sedentary behavior using dual-tasking on cerebral blood flow, vascular function, cognitive functions and blood pressure in elderly people. Participants will perform, in random order, three experimental sessions (control, break with dual-task and standard break ([walk]). All sessions will have a period of 4 hours in sedentary behavior. In the standard break session and in the break session with dual-task participants will take walking and dual-task breaks every 30 minutes, and in the control session they will remain seated without breaks. Before and after this period, cerebral blood flow, vascular function, cognitive functions and blood pressure will be assessed.
- Conditions
- Aging
- Being tested
- Break of sedentary behavior with dual task, Break of sedentary behavior with walking
- Keywords
- sedentary behavior, physical activity, cognitive function, vascular function
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Break of sedentary behavior with dual taskOther
Patients will interrupt sedentary behavior performing walking and cognitive activities simultaneously
Break of sedentary behavior with walkingOther
Patients will interrupt sedentary behavior performing walking
| Study group | Role | What they receive |
|---|---|---|
| Break dual task | Experimental | Subjects will remain seated for three hours; however, every 30 minutes the subjects will be instructed to stand and take short walks with low intensity and perform a cognitive task Receives: Other: Break of sedentary behavior with dual task |
| Standard break | Active comparator | Subjects will remain seated for three hours, however, every 30 minutes the subjects will be instructed to stand and take short walks at low intensity for two minutes, Receives: Other: Break of sedentary behavior with walking |
| Control session | No intervention | Subjects will remain seated for three hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood velocity [centimeters per second]
Mean arterial velocity of middle cerebral artery will be measured using a transcranial doppler
Measured: Before and 20 minutes after the intervention for 5 minutes
Cognitive function - The Trail Making Tests [seconds]
The Trail Making Tests (A and B) will be used to assess executive function and attention. Part A will determine psychomotor speed and require the participant to draw lines connecting sequentially circled numbers, such as drawing a line from 1 to 2, 2 to 3, and 3 to 4. Part B will consist of circled numbers and letters. Participants will be instructed to draw a line as quickly and as accurately as possible from 1 to A, A to 2, 2 to B, B to 3, and so on, until they complete the task. The time in seconds will be recorded in seconds after the end of each stage. After carrying out the tests, the differences between the completion times for part B - A will be calculated.
Measured: Before and 30 minutes after the intervention
Cognitive function - Stroop test [seconds]
A computerized version of the Stroop test will be used in this study, using the Testinpacs® program. The tasks will be viewed on a notebook screen approximately 90 cm away from the participant. Answers to a set of tasks will be given as quickly as possible via two buttons. The cognitive portion of the Stroop test will be used as a psychometric test to assess cognition, being related to the executive functions of decision-making and inhibitory control exercised by the prefrontal cortex. The capacity for selective attention and response control will be estimated as the time difference between the third condition and the second condition. Smaller differences will indicate better selective attention and conflict resolution.
Measured: Before and 32 minutes after the intervention
Cognitive function - verbal fluency [number of animal names reported]
The task will consist of recalling words that begin with the letter "F", for 60 seconds. The final score will be determined according to the number of correct words reported in 60 seconds. In the semantic modality, participants must evoke as many animals as possible in 60 seconds. The final score will be determined according to the number of animal names reported in 60 seconds.
Measured: Before and 35 minutes after the intervention
Secondary outcomes (4)
Resting systolic and diastolic blood pressures [mmHg]
Resting systolic and diastolic blood pressures will be assessed with an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
Measured: Before and 10 minutes after the intervention
Resting heart rate [bpm]
Resting heart rate will be assessed with an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
Measured: Before and 10 minutes after the intervention
Ambulatory systolic, diastolic, and mean blood pressures monitoring [mmHg]
The systolic, diastolic, and mean blood pressures during 24 hours will be measured using a non-invasive oscillometric device (Dynamapa)
Measured: 45 minutes after the intervention
Vascular function [%]
Vascular function will be measured with the flow-mediated dilation according to the global recommendations on popliteal artery before and after 15 minutes of intervention by a bidimensional ultrasonography device with spectral Doppler and linear transducer.
Measured: Before and 10 minutes after 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 Oct 2023
- Study start27 Feb 2023
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Mendes Ritti Dias, University of Nove de Julho
- Investigators
- Raphael Dias, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068374
- Sponsor's protocol ID
- Break_Elderly
- Status last verified
- Dec 2024
- First submitted
- 22 Sep 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Breaks From Sedentary Behavior With Dual Tasks on Cerebral Blood Flow, Cognitive Function, Blood Pressure and Vascular Function in the Elderly
- ClinicalTrials.gov ID
- NCT06068374
- Acronym / sponsor ID
- Break_Elderly
- Conditions
- Aging
- Keywords
- sedentary behavior, physical activity, cognitive function, vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 5 Oct 2023 (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 aim of this project will be to compare the acute effects of breaks from sedentary behavior using dual-tasking on cerebral blood flow, vascular function, cognitive functions and blood pressure in elderly people. Participants will perform, in random order, three experimental sessions (control, break with dual-task and standard break ([walk]). All sessions will have a period of 4 hours in sedentary behavior. In the standard break session and in the break session with dual-task participants will take walking and dual-task breaks every 30 minutes, and in the control session they will remain seated without breaks. Before and after this period, cerebral blood flow, vascular function, cognitive functions and blood pressure will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Break dual task | Experimental | Other: Break of sedentary behavior with dual taskSubjects will remain seated for three hours; however, every 30 minutes the subjects will be instructed to stand and take short walks with low intensity and perform a cognitive task |
| Standard break | Active comparator | Other: Break of sedentary behavior with walkingSubjects will remain seated for three hours, however, every 30 minutes the subjects will be instructed to stand and take short walks at low intensity for two minutes, |
| Control session | No intervention | –Subjects will remain seated for three hours |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- aged 60 years or over
- be physically independent based on the Katz Test
- have no history of heart attack
- not having suffered a stroke
- not have heart failure
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Break of sedentary behavior with dual taskPatients will interrupt sedentary behavior performing walking and cognitive activities simultaneously | Other | Break dual task |
| Break of sedentary behavior with walkingPatients will interrupt sedentary behavior performing walking | Other | Standard break |
Primary outcome
Cerebral blood velocity [centimeters per second]
Time frame: Before and 20 minutes after the intervention for 5 minutes
Mean arterial velocity of middle cerebral artery will be measured using a transcranial doppler
Cognitive function - The Trail Making Tests [seconds]
Time frame: Before and 30 minutes after the intervention
The Trail Making Tests (A and B) will be used to assess executive function and attention. Part A will determine psychomotor speed and require the participant to draw lines connecting sequentially circled numbers, such as drawing a line from 1 to 2, 2 to 3, and 3 to 4. Part B will consist of circled numbers and letters. Participants will be instructed to draw a line as quickly and as accurately as possible from 1 to A, A to 2, 2 to B, B to 3, and so on, until they complete the task. The time in seconds will be recorded in seconds after the end of each stage. After carrying out the tests, the differences between the completion times for part B - A will be calculated.
Cognitive function - Stroop test [seconds]
Time frame: Before and 32 minutes after the intervention
A computerized version of the Stroop test will be used in this study, using the Testinpacs® program. The tasks will be viewed on a notebook screen approximately 90 cm away from the participant. Answers to a set of tasks will be given as quickly as possible via two buttons. The cognitive portion of the Stroop test will be used as a psychometric test to assess cognition, being related to the executive functions of decision-making and inhibitory control exercised by the prefrontal cortex. The capacity for selective attention and response control will be estimated as the time difference between the third condition and the second condition. Smaller differences will indicate better selective attention and conflict resolution.
Cognitive function - verbal fluency [number of animal names reported]
Time frame: Before and 35 minutes after the intervention
The task will consist of recalling words that begin with the letter "F", for 60 seconds. The final score will be determined according to the number of correct words reported in 60 seconds. In the semantic modality, participants must evoke as many animals as possible in 60 seconds. The final score will be determined according to the number of animal names reported in 60 seconds.
4 secondary outcomes
Resting systolic and diastolic blood pressures [mmHg]
Time frame: Before and 10 minutes after the intervention
Resting heart rate [bpm]
Time frame: Before and 10 minutes after the intervention
Ambulatory systolic, diastolic, and mean blood pressures monitoring [mmHg]
Time frame: 45 minutes after the intervention
Vascular function [%]
Time frame: Before and 10 minutes after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Yes
Related trials for Aging
Enrolling by invitationPhase 2
Tirzepatide and Organ-specific Biological Aging
Longevity, Preventive Medicine
Active, not recruiting
Emotional Well-being and Measures of Healthy Aging
Aging, Aging, Healthy
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruiting
Vascular Aging and Lp299v Study in Healthy Adults
Vascular Aging
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
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.
Raphael Dias, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Break of sedentary behavior with dual task and Break of sedentary behavior with walking in people with Aging, run by University of Nove de Julho at 1 site in Brazil.
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 10 inclusion and 0 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: finished, as of the sponsor's last update on 4 Dec 2024. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cerebral blood velocity [centimeters per second] (time frame: Before and 20 minutes after the intervention for 5 minutes). 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 4 Dec 2024.