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Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03591198
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
Fujian University of Traditional Chinese Medicine
Information provided by (Responsible Party):
TSANG Hector Wing-Hong, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Chronic Disease Depressive Symptoms Behavioral: Qigong Training Behavioral: Cognitive Training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise: A Randomized Controlled Trial
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Qigong Training Behavioral: Qigong Training
Eight-Section Brocades

Active Comparator: Cognitive Training Behavioral: Cognitive Training
Cognitive Training of Memory and Executive Function with Activities requiring Mobilization




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Functional Independence Measure (FIM) [ Time Frame: baseline, 12 weeks after baseline, and 16 weeks after baseline ]
    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.

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: baseline, 12 weeks after baseline, and 16 weeks after baseline ]
    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.

  3. Timed up and Go Test (TUG) [ Time Frame: baseline, 12 weeks after baseline, and 16 weeks after baseline ]
    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.

  4. Handgrip Strength [ Time Frame: baseline, 12 weeks after baseline, and 16 weeks after baseline ]
    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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591198


Locations
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Hong Kong
The Hong Kong Polytechinic University
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Fujian University of Traditional Chinese Medicine
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Responsible Party: TSANG Hector Wing-Hong, Professor and Head of Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03591198    
Other Study ID Numbers: 81173316-1
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Depression
Disease Attributes
Pathologic Processes
Behavioral Symptoms