Breaks From Sedentary Behavior With Dual Tasks in Elderly
Acute Effects of Breaks From Sedentary Behavior With Dual Tasks on Cerebral Blood Flow, Cognitive Function, Blood Pressure and Vascular Function in the Elderly
1 other identifier
interventional
27
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2023
CompletedFirst Submitted
Initial submission to the registry
September 22, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2024
CompletedDecember 4, 2024
December 1, 2024
1.4 years
September 22, 2023
December 3, 2024
Conditions
Keywords
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
EXPERIMENTALSubjects 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 COMPARATORSubjects 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 INTERVENTIONSubjects will remain seated for three hours
Interventions
Patients will interrupt sedentary behavior performing walking and cognitive activities simultaneously
Patients will interrupt sedentary behavior performing walking
Eligibility Criteria
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Raphael Dias, PhD
University of Nove de Julho
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