Neurophysiological RCT of Qigong in Elderly With Depression

NCT ID: NCT05000788

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2026-03-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Qigong Group

Group Type: EXPERIMENTAL

Qigong

Intervention Type: BEHAVIORAL

Eight-Section Brocades Practice: The treatment group will undergo an 8-week Eight-Section Brocades intervention program consists of a total of 16 group training sessions with two 1-hour sessions per week. The treatment group participants will be provided with health qigong exercise in a group format led by qualified qigong instructors. All the health qigong instructors will be trained by a certified Traditional Chinese Medicine (TCM) practitioner with an expertise in health qigong and they are required to pass the certification examination before delivering health qigong intervention at the clinical settings. The Eight-Section Brocades protocol will be used in this study because it is easy to learn by the participants and the clinical effects on psychosocial health were evidenced in previous RCTs. A complete cycle of the Eight-Section Brocades took 12 minutes for completion, which consists of eight sequential and simple forms of movements.

Exercise Group

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: BEHAVIORAL

Exercise Program: Participants in the control group will attend a physical exercise program for 8 weeks (1-hour sessions, 2 times a week). The exercise program will incorporate aerobic fitness, strength training, body weight workouts, balance training, flexibility and stretching into the training plan. The exercise program is provided in a group format, which will be led by qualified physical trainer.

Interventions

Qigong

Eight-Section Brocades Practice: The treatment group will undergo an 8-week Eight-Section Brocades intervention program consists of a total of 16 group training sessions with two 1-hour sessions per week. The treatment group participants will be provided with health qigong exercise in a group format led by qualified qigong instructors. All the health qigong instructors will be trained by a certified Traditional Chinese Medicine (TCM) practitioner with an expertise in health qigong and they are required to pass the certification examination before delivering health qigong intervention at the clinical settings. The Eight-Section Brocades protocol will be used in this study because it is easy to learn by the participants and the clinical effects on psychosocial health were evidenced in previous RCTs. A complete cycle of the Eight-Section Brocades took 12 minutes for completion, which consists of eight sequential and simple forms of movements.

Intervention Type: BEHAVIORAL

Exercise

Exercise Program: Participants in the control group will attend a physical exercise program for 8 weeks (1-hour sessions, 2 times a week). The exercise program will incorporate aerobic fitness, strength training, body weight workouts, balance training, flexibility and stretching into the training plan. The exercise program is provided in a group format, which will be led by qualified physical trainer.

Intervention Type: BEHAVIORAL

Other Intervention Names

Baduanjin

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Dr Yvonne Han

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hector Tsang, PhD

Role: STUDY_CHAIR

The Hong Kong Polytechnic University

Locations

Buddhist Ho L.F. Tak Elderly Social Centre

North Point, HK Island, Hong Kong

Countries

Hong Kong

Other Identifiers

HSEARS20210611001

Identifier Type: -

Identifier Source: org_study_id