- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06952166
Understanding the Psychological Benefits and Neurophysiological Mechanisms of Qigong in Older Adults
One goal of the study is to evaluate the efficacy of qigong to alleviate depressive symptoms and enhance cognitive function in comparison to mindfulness-based intervention, physical exercise, and waitlist control. The other goal is to explore the changes in neurobiological markers that may explain the qigong-related effects on depressive symptoms and cognitive function. The main research questions are:
- Is the 12-week qigong training more effective than mindfulness-based intervention, physical exercise, and waitlist control to alleviate depressive symptoms?
- Is the 12-week qigong training more effective than mindfulness-based intervention, physical exercise, and waitlist control to enhance 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hector Tsang
- Phone Number: 27666750
- Email: hector.tsang@polyu.edu.hk
Study Contact Backup
- Name: Erin Lu
- Email: erin.lu@polyu.edu.hk
Study Locations
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Kowloon, Hong Kong
- Hong Kong Polytechnic University, Department of Rehabilitation Sciences
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Contact:
- Hector Tsang
- Phone Number: 27666750
- Email: hector.tsang@polyu.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
- Be able to communicate in Cantonese or Mandarin.
Exclusion Criteria:
- Have 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 intervention
- Have changed medications or the dose of medications prescribed for their health condition in the one month prior to study enrollment
- Have severe cognitive or language impairment based on the assessment with Montreal Cognitive Assessment (MoCA)
- Taking medication or undergoing electroconvulsive therapy, psychotherapy, or psychoeducation for a psychological or psychiatric condition
- Unable to demonstrate satisfactory standing balance
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Qigong (Baduanjin)
12-week training of Baduanjin, with two sessions per week.
Each session lasts for 60 min.
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Participants will receive 24 sessions of Baduanjin training over 12 weeks (2 sessions per week).
Each session will last for 60 minutes.
Baduanjin consists of eight forms of gentle movements, and it takes about 10 to 15 minutes to complete a full cycle.
Participants will learn to practice each form gradually over the first 12 sessions.
In the remaining 12 sessions, the participants will go through all the movements 2-3 times, with guided practice on rhythmic breathing and mind regulation (attention to body and breathing) to be performed in coordination with the movements.
The training will be delivered by an instructor after training by the project team.
|
|
Active Comparator: Mindfulness-based intervention
12-week training of mindfulness-based breathing, walking, and stretching practices, with two sessions per week.
Each session lasts for 60 min.
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Participants will receive mindfulness-based intervention with the same duration and frequency as qigong group.
The intervention incorporates psychoeducation on mindfulness and stress management and group-based mindfulness practice about breathing, awareness of body sensations, thoughts, stretching, and walking.
All the mindfulness practices are based on publicly accessible audio recordings.
The training will be delivered by an instructor after training by the project team.
|
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Active Comparator: Physical exercise
12-week training of stretching, flexibility exercise, and balance exercise, with two sessions per week.
Each session lasts for 60 min.
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Participants of the physical exercise group will receive training of a series of low-to-moderate intensity physical activities for the same duration and frequency as qigong group.
The physical activities include stretching, flexibility exercise, balance exercise, and aerobic exercise.
The training will be delivered by an instructor after training by the project team.
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No Intervention: Waitlist control
Participants of the waitlist control group will not receive any training while the other three group are having their interventions.
After the completion of the all assessments, the participants will receive the 12-week qigong training, same as the qigong group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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The eight-item Patient Health Questionnaire
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Baseline and post-intervention (12 weeks after baseline)
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Global cognitive function
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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Montreal Cognitive Assessment
|
Baseline and post-intervention (12 weeks after baseline)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum adiponectin
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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Collected and assayed through peripheral blood sample
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Baseline and post-intervention (12 weeks after baseline)
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Serum BDNF
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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Collected and assayed through peripheral blood sample
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Baseline and post-intervention (12 weeks after baseline)
|
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Salivary cortisol
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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Collected and assayed through saliva sample
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Baseline and post-intervention (12 weeks after baseline)
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Attention
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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Attention Network Task
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Baseline and post-intervention (12 weeks after baseline)
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Inhibitory control
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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Attention Network Task
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Baseline and post-intervention (12 weeks after baseline)
|
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Working memory
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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N-back Task
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Baseline and post-intervention (12 weeks after baseline)
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ERP N2 amplitude
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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ERP data recorded during Attention Network Task and N-back Task
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Baseline and post-intervention (12 weeks after baseline)
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ERP P3 amplitude
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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ERP data recorded during Attention Network Task and N-back Task
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Baseline and post-intervention (12 weeks after baseline)
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Hand grip strength
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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To be assessed with a Jamar handheld dynamometer
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Baseline and post-intervention (12 weeks after baseline)
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Affect
Time Frame: Baseline and post-intervention (12 weeks after baseline)
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Positive and Negative Affect Schedule
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Baseline and post-intervention (12 weeks after baseline)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 15104721-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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