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CompletedNCT06068374Updated Dec 4, 2024

Breaks From Sedentary Behavior With Dual Tasks in Elderly

An interventional study of Break of sedentary behavior with dual task and Break of sedentary behavior with walking in Aging, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 60 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by University of Nove de Julho · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Feb 2023, registered Sep 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
27
Allocation
Randomized
Ages
60 Years to 90 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Aging

Keywords

  • sedentary behavior
  • physical activity
  • cognitive function
  • vascular function
03

In context

Lead sponsor

University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 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
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
27 participants (actual)

Study arms

  • Experimental
    Break dual task

    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

    Other: Break of sedentary behavior with dual task

  • Active comparator
    Standard break

    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,

    Other: Break of sedentary behavior with walking

  • No intervention
    Control session

    Subjects will remain seated for three hours

Interventions

  • OtherBreak of sedentary behavior with dual task

    Patients will interrupt sedentary behavior performing walking and cognitive activities simultaneously

  • OtherBreak of sedentary behavior with walking

    Patients will interrupt sedentary behavior performing walking

06

What researchers measure

Primary outcomes

  1. Cerebral blood velocity [centimeters per second]

    Mean arterial velocity of middle cerebral artery will be measured using a transcranial doppler

    Time frame: Before and 20 minutes after the intervention for 5 minutes

  2. 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.

    Time frame: Before and 30 minutes after the intervention

  3. 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.

    Time frame: Before and 32 minutes after the intervention

  4. 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.

    Time frame: Before and 35 minutes after the intervention

Secondary outcomes

  1. 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).

    Time frame: Before and 10 minutes after the intervention

  2. Resting heart rate [bpm]

    Resting heart rate will be assessed with an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).

    Time frame: Before and 10 minutes after the intervention

  3. 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)

    Time frame: 45 minutes after the intervention

  4. 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.

    Time frame: Before and 10 minutes after the intervention

07

Study locations

1 site
  • Universidade Nove de Julho
    São Paulo, 01504-001, Brazil
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06068374
Lead sponsor
University of Nove de Julho
Responsible party
Raphael Mendes Ritti Dias (Principal Investigator, University of Nove de Julho) — Principal investigator
First posted
Oct 5, 2023
Start date
Feb 27, 2023
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Dec 4, 2024

Study contacts

Raphael Dias, PhD
principal investigator · University of Nove de Julho

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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