- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06804408
Unpacking the "Mind" and "Body" Pathways of the Antidepressant Effect of Qigong in Older Adults: A Pilot 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Kowloon, Hong Kong
- Hong Kong Polytechnic University, Department of Rehabilitation Sciences
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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.
Exclusion Criteria:
- 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.
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
12-week training of Baduanjin (or named Eight-Section Brocades), with two sessions per week.
Each session lasts for 60 min.
|
12-week training of Baduanjin (or named Eight-Section Brocades), with two sessions per week.
Each session lasts for 60 min.
|
|
Active Comparator: Mindfulness-based Training
12-week training of mindfulness-based breathing, walking, and stretching practices, with two sessions per week.
Each session lasts for 60 min.
|
12-week training of mindfulness-based breathing, walking, and stretching practices, with two sessions per week.
Each session lasts for 60 min.
|
|
Active Comparator: Low-to-moderate Intensity Physical Exercise
12-week training of stretching, flexibility exercise, and balance exercise, with two sessions per week.
Each session lasts for 60 min.
|
12-week training of stretching, flexibility exercise, and balance exercise, with two sessions per week.
Each session lasts for 60 min.
|
|
No Intervention: Waitlist
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
The eight-item Patient Health Questionnaire
|
Baseline and post-intervention (12 weeks after baseline)
|
|
Global cognitive function
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
Montreal Cognitive Assessment
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Baseline and post-intervention (12 weeks after baseline)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum adiponectin
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
Collected and assayed through peripheral blood sample
|
Baseline and post-intervention (12 weeks after baseline)
|
|
Serum BDNF
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
Collected and assayed through peripheral blood sample
|
Baseline and post-intervention (12 weeks after baseline)
|
|
Salivary cortisol
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
Collected and assayed through saliva sample
|
Baseline and post-intervention (12 weeks after baseline)
|
|
Attention
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
Attention Network Task; Only collected from participants of Qigong and Waitlist groups
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Baseline and post-intervention (12 weeks after baseline)
|
|
Inhibitory control
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
Attention Network Task; Only collected from participants of Qigong and Waitlist groups
|
Baseline and post-intervention (12 weeks after baseline)
|
|
Working memory
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
N-back Task; Only collected from participants of Qigong and Waitlist groups
|
Baseline and post-intervention (12 weeks after baseline)
|
|
ERP N2 amplitude
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
ERP data recorded during Attention Network Task and N-back Task; Only collected from participants of Qigong and Waitlist groups
|
Baseline and post-intervention (12 weeks after baseline)
|
|
ERP P3 amplitude
Time Frame: Baseline and post-intervention (12 weeks after baseline)
|
ERP data recorded during Attention Network Task and N-back Task; Only collected from participants of Qigong and Waitlist groups
|
Baseline and post-intervention (12 weeks after baseline)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 15104721-1
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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