Neurophysiological Effects of Mind-body Exercise in Healthy Adults

Healthy Clinical Trial

Official title:

Enhanced Executive Functioning After Single-session Mind-body Practice is Associated With Changes in Prefrontal Hemodynamics: a 3-armed Randomized Controlled Functional Near Infra-red Spectroscopy (fNIRS) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06337344
• Other study ID #: HSEARS20230213007
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: April 2024

Study information

• Verified date: March 2024
• Source: The Hong Kong Polytechnic University
• Contact: Yvonne Han, PhD
• Phone: +852 2766 7578
• Email: yvonne.han[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is some clinical evidence showing that Baduanjin (BDJ) practice, a type of mind-body based physical exercise, can improve executive function (EF). However, the neurophysiological changes associated with improved cognitive function remain elusive. Therefore, this study aims to carry out randomised controlled trial to explore how the single-session BDJ practice affect the function of prefrontal cortex(PFC) and also the EF of healthy adults, measure by fNIRS and verbal fluency test accordingly. A total of 60 healthy adults (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 18 to 40 year old, without any physical, neurological, and neuropsychiatric disorder, classified as right-handed by Edinburgh Handedness Inventory, also with normal intelligence as verified by the Test of Nonverbal Intelligence will be recruited and randomly assigned to treatment(i.e. BDJ), active control(i.e, exercise), and passive control(i.e. video viewing) group. The investigator anticipate that this single-session BDJ practice will result in - (1) enhancing executive functioning , and (2) changes in functional brain activation pattern in PFC in adults. The result will give a spotlight to neurophysiological treatment effect of single-session Baduanjin on healthy adults, in developing intervention for improving executive functioning of adults.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Right-handed adults with normal intelligence (i.e. intelligence quotient = 80), and without any physical, neuropsychiatric, and neurological disorders

Exclusion Criteria:

• Current positive history of head injury, seizure, stroke, other central nervous system diseases, other comorbid psychiatric illness, or reports of strong suicidal ideation.

Related Conditions & MeSH terms

• Healthy

Intervention

Behavioral:
• Baduanjin
The treatment group will individually perform single-session Baduanjin by following a video broadcasted the standardised BDJ protocol, which lasted for 12 minutes including 6 times of BDJ movements. Breathing rhythm is emphasised to be followed by participants.
• Exercise
The active control group will individually perform 8-sets of aerobic exercise movement by following a video selected by registered physiotherapist.
• Video Viewing
The control group will individually watch a 12-minute video with 6-minute introducing BDJ practice and 6 minute introducing aerobic exercise. This control group is used for controlling the effect of behavioural movement and brain activity generated by passive video viewing.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hung Hom	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive function as assessed by verbal fluency task (VFT)	Verbal fluency task (VFT). Executive functions are measured using the VFT. The experimental design of this task is adapted from previous fNIRS studies of verbal fluency where task blocks were interleaved with control blocks. Participants are required to generate exemplars of two semantic categories (i.e., animal and means of transportation) as many as possible, each for one minute, during the task blocks. This experimental task will begin with a 30-second phrase repetition period as a control, followed immediately by a 60-second task period (i.e, animal words), a 60-second control period, another 60-second task period (i.e., transportation words), and ended with another 60-second control period. The total measurement period is 270 seconds. The total number of correct and unique responses will be computed to reflect their fluency ability.	17 min after baseline
Primary	Hemodynamic changes as assessed by fNIRS	NIRSIT Lite is a portable, non-invasive neuroimaging procedure used to measure hemodynamic changes, in terms of oxyhemoglobin (HbO), deoxyhemoglobin (HbR) and total hemoglobin (HbT), associated with neuronal activities of the cerebral cortex in response to attending a task within the given period of time. Optical signals will be recorded on a two-wavelength (780 and 850 nm), continuous-wave optical imaging system (NIRSIT Lite; OBELAB Co., Seoul, South Korea). The 15 channels with a 30-mm source-detector separation which cover the entire PFC area will be used in this study. In accordance with the international 10-20 EEG system, the center of the bottom probe row will be placed at the reference point Fpz. Consequently, channel 1 to channel 7 represent the right PFC, and channel 9 to channel 15 the left PFC. In addition, NIRSIT has an embedded gyroscope that enables online removal of motion artifacts.	Baseline, during the 12-min intervention(immediate after baseline), immediate post-assessment(12 min after baseline)