NCT06068374

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

1.4 years

First QC Date

September 22, 2023

Last Update Submit

December 3, 2024

Conditions

Keywords

sedentary behaviorphysical activitycognitive functionvascular function

Outcome Measures

Primary Outcomes (4)

  • Cerebral blood velocity [centimeters per second]

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

    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.

    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.

    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.

    Before and 35 minutes after the intervention

Secondary Outcomes (4)

  • Resting systolic and diastolic blood pressures [mmHg]

    Before and 10 minutes after the intervention

  • Resting heart rate [bpm]

    Before and 10 minutes after the intervention

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

    45 minutes after the intervention

  • Vascular function [%]

    Before and 10 minutes after the intervention

Study Arms (3)

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

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,

Other: Break of sedentary behavior with walking

Control session

NO INTERVENTION

Subjects will remain seated for three hours

Interventions

Patients will interrupt sedentary behavior performing walking and cognitive activities simultaneously

Break dual task

Patients will interrupt sedentary behavior performing walking

Standard break

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nove de Julho

São Paulo, 01504-001, Brazil

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Walking

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor Activity

Study Officials

  • Raphael Dias, PhD

    University of Nove de Julho

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluator of flow-mediated dilation is blinded
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 22, 2023

First Posted

October 5, 2023

Study Start

February 27, 2023

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
One year after the completion
Access Criteria
Upon request

Locations