Chronic DiseaseNCT03591198
Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise
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
Qigong exercise is beneficial for older adults with co-occurring chronic physical illness and depression in terms of psychological and physical outcomes. However, the effects on functional independence, sleep quality, and mobility of depressive older adults remain unclear. 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
- 47 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2015to 31 May 2017
- 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
Official title: Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise: A Randomized Controlled Trial
Qigong exercise is beneficial for older adults with co-occurring chronic physical illness and depression in terms of psychological and physical outcomes. However, the effects on functional independence, sleep quality, and mobility of depressive older adults remain unclear. It is also important to replicate its benefits for subjective well-being and muscle strength. A randomized clinical trial was conducted among older adults who were aged 60 or above and with chronic medical conditions for one year. After random assignment, intervention group (n = 25) went through qigong exercise twice a week and for 12 weeks,whereas control group (n = 22) was involved in cognitive training activities with mobilization elements. The psychosocial and physical 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
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.
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: the change from baseline to the completion of intervention (12 weeks later)
Secondary outcomes (4)
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 Oct 2015
- Primary completion31 Mar 2017
- Study completion31 May 2017
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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- NCT03591198
- Sponsor's protocol ID
- 81173316-1
- Status last verified
- Jul 2018
- First submitted
- 26 Jun 2018
- Last updated
- 20 Jul 2018
- 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 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03591198
- Acronym / sponsor ID
- 81173316-1
- Conditions
- Chronic Disease, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Fujian University of Traditional Chinese Medicine
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 May 2017 (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.
Qigong exercise is beneficial for older adults with co-occurring chronic physical illness and depression in terms of psychological and physical outcomes. However, the effects on functional independence, sleep quality, and mobility of depressive older adults remain unclear. It is also important to replicate its benefits for subjective well-being and muscle strength. A randomized clinical trial was conducted among older adults who were aged 60 or above and with chronic medical conditions for one year. After random assignment, intervention group (n = 25) went through qigong exercise twice a week and for 12 weeks,whereas control group (n = 22) was involved in cognitive training activities with mobilization elements. The psychosocial and physical 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 | Behavioural | Qigong Training |
| Cognitive TrainingCognitive Training of Memory and Executive Function with Activities requiring Mobilization | Behavioural | Cognitive Training |
Primary outcome
Personal Well-Being Index (PWI)
Time frame: the change from baseline to the completion of intervention (12 weeks later)
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.
4 secondary outcomes
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 20 Jul 2018.
- Individual participant dataSharing planned: No
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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 20 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?
Personal Well-Being Index (PWI) (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 20 Jul 2018.