NCT06804408

Brief Summary

The goals of the study are to explore the neurobiological mechanisms and cognitive benefits of qigong in older adults. The main research questions are:

  • Does 12-week qigong training lead to significant enhancement in serum adiponectin, serum BDNF and significant reduction in salivary cortisol?
  • Does 12-week qigong training bring significant improvement in global 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

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

January 1, 2025

Enrollment Period

1.1 years

First QC Date

January 7, 2025

Last Update Submit

January 27, 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 (8)

  • 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)

  • +3 more secondary outcomes

Study Arms (4)

Qigong

EXPERIMENTAL

12-week training of Baduanjin (or named Eight-Section Brocades), with two sessions per week. Each session lasts for 60 min.

Behavioral: Qigong

Mindfulness-based Training

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 training

Low-to-moderate Intensity 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: Low-to-moderate intensity physical exercise

Waitlist

NO INTERVENTION

No training while the other three group are receiving training. Participants of this group are allowed to have Qigong, Mindfulness-based Training, or Low-to-moderate Intensity Physical Exercise after they complete all the assessments.

Interventions

QigongBEHAVIORAL

12-week training of Baduanjin (or named Eight-Section Brocades), with two sessions per week. Each session lasts for 60 min.

Qigong

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

Mindfulness-based Training

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

Low-to-moderate Intensity 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.

You may not qualify if:

  • With 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 study enrollment
  • Having changed medications or the dose of medications prescribed for their health condition in the month prior to study enrollment
  • With severe cognitive or language impairment as defined as a score of less than 21 on Montreal Cognitive Assessment (MoCA-5min)
  • 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

Qigong

Intervention Hierarchy (Ancestors)

Breathing ExercisesMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

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

January 7, 2025

First Posted

February 3, 2025

Study Start

May 1, 2023

Primary Completion

May 31, 2024

Study Completion

August 31, 2024

Last Updated

February 3, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations