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

Primary Purpose

Chronic Disease, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Qigong Training
Cognitive Training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hong Kong Polytechinic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Qigong Training

Cognitive Training

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Brain Deprived Neurotrophic Factor (BDNF) Level
measured with peripheral blood samples (10 ml) collected in the morning
Serotonin 5-HT Level
measured with serum extracted from blood samples. Around 2-3 ml of serum is harvested per 5 ml of blood.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 26, 2018
Last Updated
July 29, 2018
Sponsor
The Hong Kong Polytechnic University
Collaborators
I-Shou University, Fujian University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03591211
Brief Title
Bio-psycho-social Pathways Underlying the Effects of Qigong Among Comorbid Depressed Elderly With Chronic Conditions
Official Title
Bio-psycho-social Pathways Underlying the Effects of Qigong Among Comorbid Depressed Elderly With Chronic Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
I-Shou University, Fujian University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Depressive Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Qigong Training
Arm Type
Experimental
Arm Title
Cognitive Training
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Qigong Training
Intervention Description
Eight-Section Brocades; participants were trained individually.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Training
Intervention Description
Cognitive Training of Memory and Executive Function with Activities requiring Mobilization
Primary Outcome Measure Information:
Title
Patient Health Questionnaire (PHQ)
Description
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.
Time Frame
the change from baseline to the completion of intervention (12 weeks later)
Secondary Outcome Measure Information:
Title
Salivary Cortisol Level
Description
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
Time Frame
baseline and 12 weeks after baseline
Title
Brain Deprived Neurotrophic Factor (BDNF) Level
Description
measured with peripheral blood samples (10 ml) collected in the morning
Time Frame
baseline and 12 weeks after baseline
Title
Serotonin 5-HT Level
Description
measured with serum extracted from blood samples. Around 2-3 ml of serum is harvested per 5 ml of blood.
Time Frame
baseline and 12 weeks after baseline
Title
Depression Anxiety Stress Scale (DASS-21)
Description
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.
Time Frame
baseline, 12 weeks after baseline, and 16 weeks after baseline
Title
Personal Well-Being Index (PWI)
Description
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.
Time Frame
baseline, 12 weeks after baseline, and 16 weeks after baseline
Title
Functional Independence Measure (FIM)
Description
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.
Time Frame
baseline, 12 weeks after baseline, and 16 weeks after baseline
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
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.
Time Frame
baseline, 12 weeks after baseline, and 16 weeks after baseline
Title
Timed up and Go Test (TUG)
Description
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.
Time Frame
baseline, 12 weeks after baseline, and 16 weeks after baseline
Title
Handgrip Strength
Description
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.
Time Frame
baseline, 12 weeks after baseline, and 16 weeks after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Hong Kong Polytechinic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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

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