Chronic DiseaseNCT03591211
Bio-psycho-social Pathways Underlying the Effects of Qigong Among Comorbid Depressed Elderly With Chronic Conditions
A study testing Qigong Training and Cognitive Training in people with Chronic Disease and Depressive Symptoms, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Depression and chronic medical conditions are common in older adults. Qigong is increasingly documented to have anti-depressive effects for older adults. Nevertheless, the scientific concepts behind qigong remain a mystery. To fill the knowledge gap, the neurobiological mechanism of the effects of qigong was explored. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Disease, Depressive Symptoms
- What is being tested?
- Qigong Training and Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2017to 28 Feb 2018
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 60 or above
- have been suffering from chronic medical conditions for more than one year
- have depressive symptoms as indicated by Geriatric Depression Scale (GDS ≥ 6)
Who cannot join
- have practiced or received training of any form of mind-body exercises (including tai chi, yoga, and qigong) during the 6 months prior to intervention.
- have changed medication or the dosage prior to or during intervention
- have obvious cognitive and language impairment or score less than 20 in Mini-Mental State Examination (MMSE)
- undergo electroconvulsive therapy, psychotherapy, or psychoeducation
- cannot demonstrate satisfactory sitting balance
Trial locations and contacts
1 site in 1 country.
About this study
Depression and chronic medical conditions are common in older adults. Qigong is increasingly documented to have anti-depressive effects for older adults. Nevertheless, the scientific concepts behind qigong remain a mystery. To fill the knowledge gap, the neurobiological mechanism of the effects of qigong was explored. In addition, the benefits of qigong on subjective well-being, functional independence, sleep quality, mobility, and muscle strength were also tested. After random assignment, intervention group (n = 14) went through individual qigong exercise twice a week and for 12 weeks,whereas control group (n = 16) was involved in cognitive training activities with mobilization elements. The psychosocial, physical, and neurobiological outcomes of the two groups were compared.
- Conditions
- Chronic Disease, Depressive Symptoms
- Being tested
- Qigong Training, Cognitive Training
- Medical subject headings
- Chronic Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qigong TrainingBehavioural
Eight-Section Brocades; participants were trained individually.
Cognitive TrainingBehavioural
Cognitive Training of Memory and Executive Function with Activities requiring Mobilization
| Study group | Role | What they receive |
|---|---|---|
| Qigong Training | Experimental | Not described Receives: Behavioral: Qigong Training |
| Cognitive Training | Active comparator | Not described Receives: Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ)
Patient Health Questionnaire (PHQ) is used to assess the experience of depressive symptoms. The frequency of each symptom was indicated based on a 4-point scale (0 = never; 3 = almost every day). A total score ranged from 0 to 27 can be derived, with higher score indicating severer depressive symptoms.
Measured: the change from baseline to the completion of intervention (12 weeks later)
Secondary outcomes (9)
Salivary Cortisol Level
measured with saliva sample obtained 5 times (07:00, 10:30, 13:00, 14:30, and 18:00) at two consecutive days at baseline and 12 weeks after baseline
Measured: baseline and 12 weeks after baseline
Brain Deprived Neurotrophic Factor (BDNF) Level
measured with peripheral blood samples (10 ml) collected in the morning
Measured: baseline and 12 weeks after baseline
Serotonin 5-HT Level
measured with serum extracted from blood samples. Around 2-3 ml of serum is harvested per 5 ml of blood.
Measured: baseline and 12 weeks after baseline
Depression Anxiety Stress Scale (DASS-21)
Depression Anxiety Stress Scale (DASS-21) is a 21-item scale to measure symptoms of depression, anxiety, and stress with 7 items for each. Each item is measured with 4-point from 0 (never) to 3 (almost always). The scores of depression, anxiety, and stress are the sum of all subscale items, and it can range from 0 to 21. Higher score shows more severity of depression, anxiety, and stress.
Measured: baseline, 12 weeks after baseline, and 16 weeks after baseline
Personal Well-Being Index (PWI)
It is measured by the 8-item scale of Personal Well-Being Index (PWI). Each item was rated according to an 11-point scale ranging from '0' (extremely dissatisfied) to '10' (extremely satisfied). An overall score of PWI score was the sum of all items. The overall score ranges from 0 to 110, with higher score indicating higher subjective well-being.
Measured: baseline, 12 weeks after baseline, and 16 weeks after baseline
Functional Independence Measure (FIM)
It is measured by the 18-item scale of Functional Independence Measure (FIM). Based on a 7-point scale for rating (1
= totally unable; 7 = totally independent), a total score of FIM ranges from 18 to 126 was generated. Higher total score indicates less disability.
Measured: baseline, 12 weeks after baseline, and 16 weeks after baseline
Pittsburgh Sleep Quality Index (PSQI)
It is measured by the Pittsburgh Sleep Quality Index (PSQI). It has 19 items measuring 7 components of sleep quality, and a total score is calculated as the sum of all the component scores. The total score ranges from 0 to 21, with lower score showing better sleep quality.
Measured: baseline, 12 weeks after baseline, and 16 weeks after baseline
Timed up and Go Test (TUG)
Timed up and Go Test (TUG) is used to measure mobility. During the test, participants were sitting on a chair, and then they were required to stand up, walk to a mark which is 3 meters away from the chair, go back to the chair from the mark, and sit down again. The time each participant spent to complete the above series of actions was recorded.
Participants performed the test for three times, and their final scores were the average of the three. And lower score indicates better mobility.
Measured: baseline, 12 weeks after baseline, and 16 weeks after baseline
Handgrip Strength
It is measured with a Jamar handheld dynamometer. Participants performed three trials of left hand and right hand grip strength, and the final outcome of each hand was calculated as the mean performance of the three trials. Higher score indicates stronger handgrip strength.
Measured: baseline, 12 weeks after baseline, and 16 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 posted19 Jul 2018
- Study start1 Aug 2017
- Primary completion31 Jan 2018
- Study completion28 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- I-Shou University, Fujian University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, TSANG Hector Wing-Hong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591211
- Sponsor's protocol ID
- 81173316-2
- Status last verified
- Jul 2018
- First submitted
- 26 Jun 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-psycho-social Pathways Underlying the Effects of Qigong Among Comorbid Depressed Elderly With Chronic Conditions
- ClinicalTrials.gov ID
- NCT03591211
- Acronym / sponsor ID
- 81173316-2
- Conditions
- Chronic Disease, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- I-Shou University, Fujian University of Traditional Chinese Medicine
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 19 Jul 2018 (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.
Depression and chronic medical conditions are common in older adults. Qigong is increasingly documented to have anti-depressive effects for older adults. Nevertheless, the scientific concepts behind qigong remain a mystery. To fill the knowledge gap, the neurobiological mechanism of the effects of qigong was explored. In addition, the benefits of qigong on subjective well-being, functional independence, sleep quality, mobility, and muscle strength were also tested. After random assignment, intervention group (n = 14) went through individual qigong exercise twice a week and for 12 weeks,whereas control group (n = 16) was involved in cognitive training activities with mobilization elements. The psychosocial, physical, and neurobiological outcomes of the two groups were compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Qigong Training | Experimental | Behavioral: Qigong Training |
| Cognitive Training | Active comparator | Behavioral: Cognitive Training |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 60 or above
- have been suffering from chronic medical conditions for more than one year
- have depressive symptoms as indicated by Geriatric Depression Scale (GDS ≥ 6)
Key exclusion criteria (5 listed)
- have practiced or received training of any form of mind-body exercises (including tai chi, yoga, and qigong) during the 6 months prior to intervention.
- have changed medication or the dosage prior to or during intervention
- have obvious cognitive and language impairment or score less than 20 in Mini-Mental State Examination (MMSE)
- undergo electroconvulsive therapy, psychotherapy, or psychoeducation
- cannot demonstrate satisfactory sitting 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 |
|---|---|---|
| Qigong TrainingEight-Section Brocades; participants were trained individually. | Behavioural | Qigong Training |
| Cognitive TrainingCognitive Training of Memory and Executive Function with Activities requiring Mobilization | Behavioural | Cognitive Training |
Primary outcome
Patient Health Questionnaire (PHQ)
Time frame: the change from baseline to the completion of intervention (12 weeks later)
Patient Health Questionnaire (PHQ) is used to assess the experience of depressive symptoms. The frequency of each symptom was indicated based on a 4-point scale (0 = never; 3 = almost every day). A total score ranged from 0 to 27 can be derived, with higher score indicating severer depressive symptoms.
9 secondary outcomes
Salivary Cortisol Level
Time frame: baseline and 12 weeks after baseline
Brain Deprived Neurotrophic Factor (BDNF) Level
Time frame: baseline and 12 weeks after baseline
Serotonin 5-HT Level
Time frame: baseline and 12 weeks after baseline
Depression Anxiety Stress Scale (DASS-21)
Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline
Personal Well-Being Index (PWI)
Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline
Functional Independence Measure (FIM)
Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline
Timed up and Go Test (TUG)
Time frame: baseline, 12 weeks after baseline, and 16 weeks after baseline
Handgrip Strength
Time frame: baseline, 12 weeks after baseline, and 16 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 31 Jul 2018.
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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 Training and Cognitive Training in people with Chronic Disease and Depressive Symptoms, 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 31 Jul 2018. 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?
Patient Health Questionnaire (PHQ) (time frame: the change from baseline to the completion of intervention (12 weeks later)). 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 31 Jul 2018.