Breaks From Sedentary Behavior With Dual Tasks in Elderly

Sponsor
University of Nove de Julho (Other)
Overall Status
Recruiting
CT.gov ID
NCT06068374
Collaborator
(none)
22
1
3
17.1
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Break of sedentary behavior with dual task
  • Other: Break of sedentary behavior with walking
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Outcomes Assessor)
Masking Description:
The evaluator of flow-mediated dilation is blinded
Primary Purpose:
Other
Official 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
Actual Study Start Date :
Feb 27, 2023
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Cerebral blood velocity [centimeters per second] [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] [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] [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] [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 Outcome Measures

  1. Resting systolic and diastolic blood pressures [mmHg] [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] [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] [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 [%] [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidade Nove de Julho São Paulo Brazil 01504-001

Sponsors and Collaborators

  • University of Nove de Julho

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Raphael Mendes Ritti Dias, Principal Investigator, University of Nove de Julho
ClinicalTrials.gov Identifier:
NCT06068374
Other Study ID Numbers:
  • Break_Elderly
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Raphael Mendes Ritti Dias, Principal Investigator, University of Nove de Julho

Study Results

No Results Posted as of Oct 5, 2023