Clinical trial NCT05000788: Neurophysiological RCT of Qigong in Elderly with Depression
Official title: A Randomized Controlled Neurophysiological Study of Qigong in Elderly with Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Depression
Qigong
Neurophysiology
Functional Near Infra-red Spectroscopy
fNIRS
Executive Function
Attention
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2021-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Summary of Project:

Elderly depression is a common mood disorder and the individuals will have persistent low mood and self-absorption that adversely affect their quality of life. Cognitive deficits including attention and executive function are commonly seen in elderly with depression. Qigong, a mind-body practice, is found to have an anti-depressive effect and improve cognitive functions. Yet, the underlying mechanism is still elusive. Hence, the present study aims to conduct a randomized controlled trial to investigate how the practice of Eight-Section Brocades, a type of qigong, affects the function of the central nervous system in elderly with depression, as measured by fNIRS. A total of 60 elderly (based on power analysis 80% (β= 0.20) chance (α = 0.05, two-tailed)), aged 65 or above, with depressive mood as indicated by the Geriatric Depression Scale (GDS) will be recruited and randomly assigned to the treatment (eight-section brocades) and control (exercise) groups. We anticipate that this ancient Chinese mind-body based practice will result in (1) decreased depressive moods and improved cognitive functions, and (2) acute changes in the functional brain activation patterns in the PFC in elderly with depression. The results of this study will shed light on the neurophysiological underpinnings of the therapeutic effects associated with qigong, which will be invaluable for designing intervention for elderly with depression.


Eligibility criteria: Inclusion Criteria:

* Elderly aged 65 years or above with depressive symptoms as indicated by the Geriatric Depression Scale (GDS).

Exclusion Criteria:

* Current positive history of head injury, seizure, stroke, other CNS diseases, other comorbid psychiatric illness, or reports of strong suicidal ideation.

Primary outcomes:
measure: Change in cognitive function as assessed by Attention Network Test
timeFrame: Changes in time points: Baseline, at the end of the 8 weeks, 1 months after treatment
measure: Change in cognitive function as assessed by verbal fluency task (VFT)
timeFrame: Changes in time points: Baseline, at the end of the 8 weeks, 1 months after treatment
measure: Change in cognitive function as assessed by N-back Task
timeFrame: Changes in time points: Baseline, at the end of the 8 weeks, 1 months after treatment
measure: Change in executive function as assessed by Cambridge Neuropsychological Test Automated Battery (CANTAB®)
timeFrame: Changes in time points: Baseline, at the end of the 8 weeks, 1 months after treatment
measure: Hemodynamic changes as assessed by functional near-infrared spectroscopy (fNIRS)
timeFrame: Changes in time points: Baseline, at the end of the 8 weeks, 1 months after treatment
Secondary outcomes:
measure: Change in mood as assessed by Depression Anxiety Stress Scale-21 (DASS-21)
timeFrame: Changes in time points: Baseline, at the end of the 8 weeks, 1 months after treatment
measure: Change in mood as assessed by Beck Depression Inventory-II (BDI-II)
timeFrame: Changes in time points: Baseline, at the end of the 8 weeks, 1 months after treatment
measure: Change in mood as assessed by Personal Well Being Index (PWI)
timeFrame: Changes in time points: Baseline, at the end of the 8 weeks, 1 months after treatment
Other outcomes:
Locations:
city: North Point
country: Hong Kong
facility: Buddhist Ho L.F. Tak Elderly Social Centre
state: HK Island
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Hector Tsang, PhD
role: STUDY_CHAIR
References: