QigongNCT06804408
Unpacking the "Mind" and "Body" Pathways of the Antidepressant Effect of Qigong in Older Adults: A Pilot Study
A study testing Qigong, Mindfulness-based training and Low-to-moderate intensity physical exercise in people with Qigong, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The goals of the study are to explore the neurobiological mechanisms and cognitive benefits of qigong in older adults. The main research questions are: Does 12-week qigong training lead to significant enhancement in serum adiponectin, serum BDNF and significant reduction in salivary cortisol? Does 12-week qigong… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Qigong
- What is being tested?
- Qigong, Mindfulness-based training and Low-to-moderate intensity physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2023to 31 Aug 2024
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years or older;
- With mild or severer levels of depressive symptoms as indicated by the Geriatric Depression Scale (GDS-8) scores of 5 or above, or Depression Anxiety and Stress Scale-21 (DASS-21) depression subscale scores of 4 or above
- Self-identified as physically stable and without life-threatening diseases.
Who cannot join
- With a history of practicing or receiving training of any form of mind-body or regular exercises (including tai chi, yoga, and qigong, or regular physical activity > 3 times/week) during the month prior to study enrollment
- Having changed medications or the dose of medications prescribed for their health condition in the month prior to study enrollment
- With severe cognitive or language impairment as defined as a score of less than 21 on Montreal Cognitive Assessment (MoCA-5min)
- Undergoing electroconvulsive therapy, psychotherapy, or psychoeducation for a psychological or psychiatric condition
- Unable to demonstrate satisfactory standing balance.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Hong Kong Polytechnic University, Department of Rehabilitation Sciences
Kowloon
About this study
The goals of the study are to explore the neurobiological mechanisms and cognitive benefits of qigong in older adults. The main research questions are:
- Does 12-week qigong training lead to significant enhancement in serum adiponectin, serum BDNF and significant reduction in salivary cortisol?
- Does 12-week qigong training bring significant improvement in global cognitive function?
Participants are older adults aged 60 or above. They were randomly assigned to qigong training, mindfulness training, physical exercise training, or wait-list which all last for 12 weeks. Their changes before and after the 12-week period in depressive symptoms, neurobiological markers, and cognitive functions are assessed.
- Conditions
- Qigong
- Being tested
- Qigong, Mindfulness-based training, Low-to-moderate intensity physical exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QigongBehavioural
12-week training of Baduanjin (or named Eight-Section Brocades), with two sessions per week. Each session lasts for 60 min.
Mindfulness-based trainingBehavioural
12-week training of mindfulness-based breathing, walking, and stretching practices, with two sessions per week. Each session lasts for 60 min.
Low-to-moderate intensity physical exerciseBehavioural
12-week training of stretching, flexibility exercise, and balance exercise, with two sessions per week. Each session lasts for 60 min.
| Study group | Role | What they receive |
|---|---|---|
| Qigong | Experimental | 12-week training of Baduanjin (or named Eight-Section Brocades), with two sessions per week. Each session lasts for 60 min. Receives: Behavioral: Qigong |
| Mindfulness-based Training | Active comparator | 12-week training of mindfulness-based breathing, walking, and stretching practices, with two sessions per week. Each session lasts for 60 min. Receives: Behavioral: Mindfulness-based training |
| Low-to-moderate Intensity Physical Exercise | Active comparator | 12-week training of stretching, flexibility exercise, and balance exercise, with two sessions per week. Each session lasts for 60 min. Receives: Behavioral: Low-to-moderate intensity physical exercise |
| Waitlist | No intervention | No training while the other three group are receiving training. Participants of this group are allowed to have Qigong, Mindfulness-based Training, or Low-to-moderate Intensity Physical Exercise after they complete all the assessments. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
The eight-item Patient Health Questionnaire
Measured: Baseline and post-intervention (12 weeks after baseline)
Global cognitive function
Montreal Cognitive Assessment
Measured: Baseline and post-intervention (12 weeks after baseline)
Secondary outcomes (8)
Serum adiponectin
Collected and assayed through peripheral blood sample
Measured: Baseline and post-intervention (12 weeks after baseline)
Serum BDNF
Collected and assayed through peripheral blood sample
Measured: Baseline and post-intervention (12 weeks after baseline)
Salivary cortisol
Collected and assayed through saliva sample
Measured: Baseline and post-intervention (12 weeks after baseline)
Attention
Attention Network Task; Only collected from participants of Qigong and Waitlist groups
Measured: Baseline and post-intervention (12 weeks after baseline)
Inhibitory control
Attention Network Task; Only collected from participants of Qigong and Waitlist groups
Measured: Baseline and post-intervention (12 weeks after baseline)
Working memory
N-back Task; Only collected from participants of Qigong and Waitlist groups
Measured: Baseline and post-intervention (12 weeks after baseline)
ERP N2 amplitude
ERP data recorded during Attention Network Task and N-back Task; Only collected from participants of Qigong and Waitlist groups
Measured: Baseline and post-intervention (12 weeks after baseline)
ERP P3 amplitude
ERP data recorded during Attention Network Task and N-back Task; Only collected from participants of Qigong and Waitlist groups
Measured: Baseline and post-intervention (12 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start1 May 2023
- Primary completion31 May 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for QigongStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804408
- Sponsor's protocol ID
- 15104721-1
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unpacking the "Mind" and "Body" Pathways of the Antidepressant Effect of Qigong in Older Adults: A Pilot Study
- ClinicalTrials.gov ID
- NCT06804408
- Acronym / sponsor ID
- 15104721-1
- Conditions
- Qigong
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 3 Feb 2025 (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.
The goals of the study are to explore the neurobiological mechanisms and cognitive benefits of qigong in older adults. The main research questions are:
- Does 12-week qigong training lead to significant enhancement in serum adiponectin, serum BDNF and significant reduction in salivary cortisol?
- Does 12-week qigong training bring significant improvement in global cognitive function?
Participants are older adults aged 60 or above. They were randomly assigned to qigong training, mindfulness training, physical exercise training, or wait-list which all last for 12 weeks. Their changes before and after the 12-week period in depressive symptoms, neurobiological markers, and cognitive functions are assessed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Qigong | Experimental | Behavioral: Qigong12-week training of Baduanjin (or named Eight-Section Brocades), with two sessions per week. Each session lasts for 60 min. |
| Mindfulness-based Training | Active comparator | Behavioral: Mindfulness-based training12-week training of mindfulness-based breathing, walking, and stretching practices, with two sessions per week. Each session lasts for 60 min. |
| Low-to-moderate Intensity Physical Exercise | Active comparator | Behavioral: Low-to-moderate intensity physical exercise12-week training of stretching, flexibility exercise, and balance exercise, with two sessions per week. Each session lasts for 60 min. |
| Waitlist | No intervention | –No training while the other three group are receiving training. Participants of this group are allowed to have Qigong, Mindfulness-based Training, or Low-to-moderate Intensity Physical Exercise after they complete all the assessments. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 60 years or older;
- With mild or severer levels of depressive symptoms as indicated by the Geriatric Depression Scale (GDS-8) scores of 5 or above, or Depression Anxiety and Stress Scale-21 (DASS-21) depression subscale scores of 4 or above
- Self-identified as physically stable and without life-threatening diseases.
Key exclusion criteria (5 listed)
- With a history of practicing or receiving training of any form of mind-body or regular exercises (including tai chi, yoga, and qigong, or regular physical activity > 3 times/week) during the month prior to study enrollment
- Having changed medications or the dose of medications prescribed for their health condition in the month prior to study enrollment
- With severe cognitive or language impairment as defined as a score of less than 21 on Montreal Cognitive Assessment (MoCA-5min)
- Undergoing electroconvulsive therapy, psychotherapy, or psychoeducation for a psychological or psychiatric condition
- Unable to demonstrate satisfactory standing balance.
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 |
|---|---|---|
| Qigong12-week training of Baduanjin (or named Eight-Section Brocades), with two sessions per week. Each session lasts for 60 min. | Behavioural | Qigong |
| Mindfulness-based training12-week training of mindfulness-based breathing, walking, and stretching practices, with two sessions per week. Each session lasts for 60 min. | Behavioural | Mindfulness-based Training |
| Low-to-moderate intensity physical exercise12-week training of stretching, flexibility exercise, and balance exercise, with two sessions per week. Each session lasts for 60 min. | Behavioural | Low-to-moderate Intensity Physical Exercise |
Primary outcome
Depressive symptoms
Time frame: Baseline and post-intervention (12 weeks after baseline)
The eight-item Patient Health Questionnaire
Global cognitive function
Time frame: Baseline and post-intervention (12 weeks after baseline)
Montreal Cognitive Assessment
8 secondary outcomes
Serum adiponectin
Time frame: Baseline and post-intervention (12 weeks after baseline)
Serum BDNF
Time frame: Baseline and post-intervention (12 weeks after baseline)
Salivary cortisol
Time frame: Baseline and post-intervention (12 weeks after baseline)
Attention
Time frame: Baseline and post-intervention (12 weeks after baseline)
Inhibitory control
Time frame: Baseline and post-intervention (12 weeks after baseline)
Working memory
Time frame: Baseline and post-intervention (12 weeks after baseline)
ERP N2 amplitude
Time frame: Baseline and post-intervention (12 weeks after baseline)
ERP P3 amplitude
Time frame: Baseline and post-intervention (12 weeks after baseline)
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 3 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Qigong
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Not yet recruiting
Understanding the Psychological Benefits and Neurophysiological Mechanisms of Qigong in Older Adults
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qigong, Mindfulness-based training and Low-to-moderate intensity physical exercise in people with Qigong, 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 3 inclusion and 5 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 3 Feb 2025. 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. 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?
Depressive symptoms (time frame: Baseline and post-intervention (12 weeks 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 3 Feb 2025.