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

Depressive Symptoms Clinical Trial

Official title:

Improving Health and Reducing Disability of Depressed Elderly With Chronic Conditions Through Qigong Exercise: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03591198
• Other study ID #: 81173316-1
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: May 31, 2017

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: May 31, 2017
• Est. primary completion date: March 31, 2017
• 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
• 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 (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Fujian University of Traditional Chinese Medicine

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	the change from baseline to the completion of intervention (12 weeks later)
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