Bio-psycho-social Pathways Underlying the Effects of Qigong Among Comorbid Depressed Elderly With Chronic Conditions

Depressive Symptoms Clinical Trial

Official title:

Bio-psycho-social Pathways Underlying the Effects of Qigong Among Comorbid Depressed Elderly With Chronic Conditions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591211
• Other study ID #: 81173316-2
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Chronic Disease
• Depression
• Depressive Symptoms

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