HealthyNCT06337344
Neurophysiological Effects of Mind-body Exercise in Healthy Adults
A study testing Baduanjin, Exercise and Video Viewing in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Baduanjin, Exercise and Video Viewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 79 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed adults with normal intelligence (i.e. intelligence quotient ≥ 80), and without any physical, neuropsychiatric, and neurological disorders
Who cannot join
- Current positive history of head injury, seizure, stroke, other central nervous system diseases, other comorbid psychiatric illness, or reports of strong suicidal ideation.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Baduanjin, Exercise, Video Viewing
- Keywords
- mind-body practice, Qigong, Neurophysiology, Functional Near Infra-red Spectroscopy, fNIRS, Executive Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaduanjinBehavioural
Also called Eight-Section Brocades Practice
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.
ExerciseBehavioural
The active control group will individually perform 8-sets of aerobic exercise movement by following a video selected by registered physiotherapist.
Video ViewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Baduanjin Qigong(BDJ) | Experimental | Not described Receives: Behavioral: Baduanjin |
| Aerobic exercise | Active comparator | Not described Receives: Behavioral: Exercise |
| Video viewing | Sham comparator | Not described Receives: Behavioral: Video Viewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 17 min after baseline
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.
Measured: Baseline, during the 12-min intervention(immediate after baseline), immediate post-assessment(12 min after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 Nov 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yvonne Han, The Hong Kong Polytechnic University
- Investigators
- Hector Tsang, PhD, Study chair, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337344
- Sponsor's protocol ID
- HSEARS20230213007
- Status last verified
- Jun 2024
- First submitted
- 27 Feb 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06337344
- Acronym / sponsor ID
- HSEARS20230213007
- Conditions
- Healthy
- Keywords
- mind-body practice, Qigong, Neurophysiology, Functional Near Infra-red Spectroscopy, fNIRS, Executive Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baduanjin Qigong(BDJ) | Experimental | Behavioral: Baduanjin |
| Aerobic exercise | Active comparator | Behavioral: Exercise |
| Video viewing | Sham comparator | Behavioral: Video Viewing |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Right-handed adults with normal intelligence (i.e. intelligence quotient ≥ 80), and without any physical, neuropsychiatric, and neurological disorders
Key exclusion criteria (1 listed)
- Current positive history of head injury, seizure, stroke, other central nervous system diseases, other comorbid psychiatric illness, or reports of strong suicidal ideation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaduanjinAlso: Eight-Section Brocades PracticeThe 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. | Behavioural | Baduanjin Qigong(BDJ) |
| ExerciseThe active control group will individually perform 8-sets of aerobic exercise movement by following a video selected by registered physiotherapist. | Behavioural | Aerobic exercise |
| Video ViewingThe 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. | Behavioural | Video viewing |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hector Tsang, PhD study chair
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baduanjin, Exercise and Video Viewing in people with Healthy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive function as assessed by verbal fluency task (VFT) (time frame: 17 min after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.