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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03591211
Other study ID # 81173316-2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2017
Est. completion date February 28, 2018

Study information

Verified date July 2018
Source The Hong Kong Polytechnic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date February 28, 2018
Est. primary completion date January 31, 2018
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- 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)

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Qigong Training
Eight-Section Brocades; participants were trained individually.
Cognitive Training
Cognitive Training of Memory and Executive Function with Activities requiring Mobilization

Locations

Country Name City State
Hong Kong The Hong Kong Polytechinic University Hong Kong

Sponsors (3)

Lead Sponsor Collaborator
The Hong Kong Polytechnic University Fujian University of Traditional Chinese Medicine, I-Shou University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. the change from baseline to the completion of intervention (12 weeks later)
Secondary 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 baseline and 12 weeks after baseline
Secondary Brain Deprived Neurotrophic Factor (BDNF) Level measured with peripheral blood samples (10 ml) collected in the morning baseline and 12 weeks after baseline
Secondary Serotonin 5-HT Level measured with serum extracted from blood samples. Around 2-3 ml of serum is harvested per 5 ml of blood. baseline and 12 weeks after baseline
Secondary 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. baseline, 12 weeks after baseline, and 16 weeks after baseline
Secondary 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. baseline, 12 weeks after baseline, and 16 weeks after baseline
Secondary 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.
baseline, 12 weeks after baseline, and 16 weeks after baseline
Secondary 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. baseline, 12 weeks after baseline, and 16 weeks after baseline
Secondary 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.
baseline, 12 weeks after baseline, and 16 weeks after baseline
Secondary 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. baseline, 12 weeks after baseline, and 16 weeks after baseline
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