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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06068374
Other study ID # Break_Elderly
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 27, 2023
Est. completion date July 31, 2024

Study information

Verified date September 2023
Source University of Nove de Julho
Contact Paolo Cunha, PhD
Phone +55 43 99642 6318
Email pcunha88@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 22
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 90 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Break of sedentary behavior with dual task
Patients will interrupt sedentary behavior performing walking and cognitive activities simultaneously
Break of sedentary behavior with walking
Patients will interrupt sedentary behavior performing walking

Locations

Country Name City State
Brazil Universidade Nove de Julho São Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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