- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06337344
Neurophysiological Effects of Mind-body Exercise in Healthy Adults
June 28, 2024 updated by: Dr Yvonne Han, The Hong Kong Polytechnic University
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kowloon
-
Hung Hom, Kowloon, Hong Kong
- The Hong Kong Polytechnic University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Aerobic exercise
|
The active control group will individually perform 8-sets of aerobic exercise movement by following a video selected by registered physiotherapist.
|
|
Experimental: Baduanjin Qigong(BDJ)
|
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.
Other Names:
|
|
Sham Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in cognitive function as assessed by verbal fluency task (VFT)
Time Frame: 17 min after baseline
|
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
|
|
Hemodynamic changes as assessed by fNIRS
Time Frame: Baseline, during the 12-min intervention(immediate after baseline), immediate post-assessment(12 min after baseline)
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Hector Tsang, PhD, The Hong Kong Polytechnic University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
February 27, 2024
First Submitted That Met QC Criteria
March 22, 2024
First Posted (Actual)
March 29, 2024
Study Record Updates
Last Update Posted (Actual)
July 1, 2024
Last Update Submitted That Met QC Criteria
June 28, 2024
Last Verified
June 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSEARS20230213007
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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