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

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 Overview

• Status: Recruiting
• Conditions: Aging
• Intervention / Treatment: Other: Break of sedentary behavior with dual task; Other: Break of sedentary behavior with walking

• Study Type: Interventional
• Enrollment (Estimated): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Paolo Cunha, PhD; Phone Number: +55 43 99642 6318; Email: pcunha88@hotmail.com

Study Locations

• Brazil
  • São Paulo, Brazil, 01504-001
    • Recruiting
    • Universidade Nove de Julho
    • Contact: Raphael Ritti-Dias, PhD; Phone Number: +5519999406878; Email: raphaelritti@gmail.com
    • Sub-Investigator: Paolo Cunha, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Patients will interrupt sedentary behavior performing walking and cognitive activities simultaneously
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; Patients will interrupt sedentary behavior performing walking
No Intervention: Control session; Subjects will remain seated for three hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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)	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.	Before and 10 minutes after the intervention

Collaborators and Investigators

• Sponsor: University of Nove de Julho
• Investigators: Principal Investigator: Raphael Dias, PhD, University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2023
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: September 22, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: physical activity; cognitive function; vascular function; sedentary behavior
• Other Study ID Numbers: Break_Elderly

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: One year after the completion
• IPD Sharing Access Criteria: Upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No