Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise
Primary Purpose
Chronic Disease, Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Qigong Training
Cognitive Training
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Disease
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
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
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.
Secondary Outcome Measures
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
NCT ID
NCT03591198
First Posted
June 26, 2018
Last Updated
July 18, 2018
Sponsor
The Hong Kong Polytechnic University
Collaborators
Fujian University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03591198
Brief Title
Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise
Official Title
Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2015 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
May 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
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
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.
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
47 (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
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
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
the change from baseline to the completion of intervention (12 weeks later)
Secondary Outcome Measure Information:
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
Plan to Share IPD
No
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Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise
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