NCT06337344

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

February 27, 2024

Last Update Submit

June 28, 2024

Conditions

Keywords

mind-body practiceQigongNeurophysiologyFunctional Near Infra-red SpectroscopyfNIRSExecutive Function

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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)

Study Arms (3)

Baduanjin Qigong(BDJ)

EXPERIMENTAL
Behavioral: Baduanjin

Aerobic exercise

ACTIVE COMPARATOR
Behavioral: Exercise

Video viewing

SHAM COMPARATOR
Behavioral: Video Viewing

Interventions

BaduanjinBEHAVIORAL

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.

Also known as: Eight-Section Brocades Practice
Baduanjin Qigong(BDJ)
ExerciseBEHAVIORAL

The active control group will individually perform 8-sets of aerobic exercise movement by following a video selected by registered physiotherapist.

Aerobic exercise
Video ViewingBEHAVIORAL

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.

Video viewing

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Hector Tsang, PhD

    The Hong Kong Polytechnic University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Rehabilitation Sciences

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 29, 2024

Study Start

November 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations