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Completed

NCT Number: NCT06068374

Breaks From Sedentary Behavior With Dual Tasks in 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.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Break of sedentary behavior with dual task

Other

Patients will interrupt sedentary behavior performing walking and cognitive activities simultaneously

Break of sedentary behavior with walking

Other

Patients will interrupt sedentary behavior performing walking

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Resting systolic and diastolic blood pressures [mmHg]

    Time frame: Before and 10 minutes after the intervention

    Resting systolic and diastolic blood pressures will be assessed with an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).

  2. Resting heart rate [bpm]

    Time frame: Before and 10 minutes after the intervention

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

  3. Ambulatory systolic, diastolic, and mean blood pressures monitoring [mmHg]

    Time frame: 45 minutes after the intervention

    The systolic, diastolic, and mean blood pressures during 24 hours will be measured using a non-invasive oscillometric device (Dynamapa)

  4. Vascular function [%]

    Time frame: Before and 10 minutes after the intervention

    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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 5, 2023
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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