NCT06952166

Brief Summary

One goal of the study is to evaluate the efficacy of qigong to alleviate depressive symptoms and enhance cognitive function in comparison to mindfulness-based intervention, physical exercise, and waitlist control. The other goal is to explore the changes in neurobiological markers that may explain the qigong-related effects on depressive symptoms and cognitive function. The main research questions are:

  • Is the 12-week qigong training more effective than mindfulness-based intervention, physical exercise, and waitlist control to alleviate depressive symptoms?
  • Is the 12-week qigong training more effective than mindfulness-based intervention, physical exercise, and waitlist control to enhance cognitive function? Participants are older adults aged 60 or above. They were randomly assigned to qigong training, mindfulness training, physical exercise training, or wait-list which all last for 12 weeks. Their changes before and after the 12-week period in depressive symptoms, neurobiological markers, and cognitive functions are assessed.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
May 2025May 2026

First Submitted

Initial submission to the registry

April 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

May 12, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2026

Expected
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

10 months

First QC Date

April 23, 2025

Last Update Submit

April 23, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Depressive symptoms

    The eight-item Patient Health Questionnaire

    Baseline and post-intervention (12 weeks after baseline)

  • Global cognitive function

    Montreal Cognitive Assessment

    Baseline and post-intervention (12 weeks after baseline)

Secondary Outcomes (10)

  • Serum adiponectin

    Baseline and post-intervention (12 weeks after baseline)

  • Serum BDNF

    Baseline and post-intervention (12 weeks after baseline)

  • Salivary cortisol

    Baseline and post-intervention (12 weeks after baseline)

  • Attention

    Baseline and post-intervention (12 weeks after baseline)

  • Inhibitory control

    Baseline and post-intervention (12 weeks after baseline)

  • +5 more secondary outcomes

Study Arms (4)

Qigong (Baduanjin)

EXPERIMENTAL

12-week training of Baduanjin, with two sessions per week. Each session lasts for 60 min.

Behavioral: Qigong (Baduanjin)

Mindfulness-based intervention

ACTIVE COMPARATOR

12-week training of mindfulness-based breathing, walking, and stretching practices, with two sessions per week. Each session lasts for 60 min.

Behavioral: Mindfulness-based intervention

Physical exercise

ACTIVE COMPARATOR

12-week training of stretching, flexibility exercise, and balance exercise, with two sessions per week. Each session lasts for 60 min.

Behavioral: Physical exercise

Waitlist control

NO INTERVENTION

Participants of the waitlist control group will not receive any training while the other three group are having their interventions. After the completion of the all assessments, the participants will receive the 12-week qigong training, same as the qigong group.

Interventions

Participants will receive 24 sessions of Baduanjin training over 12 weeks (2 sessions per week). Each session will last for 60 minutes. Baduanjin consists of eight forms of gentle movements, and it takes about 10 to 15 minutes to complete a full cycle. Participants will learn to practice each form gradually over the first 12 sessions. In the remaining 12 sessions, the participants will go through all the movements 2-3 times, with guided practice on rhythmic breathing and mind regulation (attention to body and breathing) to be performed in coordination with the movements. The training will be delivered by an instructor after training by the project team.

Qigong (Baduanjin)

Participants will receive mindfulness-based intervention with the same duration and frequency as qigong group. The intervention incorporates psychoeducation on mindfulness and stress management and group-based mindfulness practice about breathing, awareness of body sensations, thoughts, stretching, and walking. All the mindfulness practices are based on publicly accessible audio recordings. The training will be delivered by an instructor after training by the project team.

Mindfulness-based intervention

Participants of the physical exercise group will receive training of a series of low-to-moderate intensity physical activities for the same duration and frequency as qigong group. The physical activities include stretching, flexibility exercise, balance exercise, and aerobic exercise. The training will be delivered by an instructor after training by the project team.

Physical exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older;
  • With mild or severer levels of depressive symptoms as indicated by the Geriatric Depression Scale (GDS-8) scores of 5 or above, or Depression Anxiety and Stress Scale-21 (DASS-21) depression subscale scores of 4 or above
  • Self-identified as physically stable and without life-threatening diseases.
  • Be able to communicate in Cantonese or Mandarin.

You may not qualify if:

  • Have a history of practicing or receiving training of any form of mind-body or regular exercises (including tai chi, yoga, and qigong, or regular physical activity \> 3 times/week) during the month prior to intervention
  • Have changed medications or the dose of medications prescribed for their health condition in the one month prior to study enrollment
  • Have severe cognitive or language impairment based on the assessment with Montreal Cognitive Assessment (MoCA)
  • Taking medication or undergoing electroconvulsive therapy, psychotherapy, or psychoeducation for a psychological or psychiatric condition
  • Unable to demonstrate satisfactory standing balance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Polytechnic University, Department of Rehabilitation Sciences

Kowloon, Hong Kong

Location

MeSH Terms

Interventions

QigongExercise

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2025

First Posted

April 30, 2025

Study Start

May 12, 2025

Primary Completion

March 15, 2026

Study Completion (Estimated)

May 31, 2026

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations