NCT03591211

Brief Summary

Depression and chronic medical conditions are common in older adults. Qigong is increasingly documented to have anti-depressive effects for older adults. Nevertheless, the scientific concepts behind qigong remain a mystery. To fill the knowledge gap, the neurobiological mechanism of the effects of qigong was explored. In addition, the benefits of qigong on subjective well-being, functional independence, sleep quality, mobility, and muscle strength were also tested. After random assignment, intervention group (n = 14) went through individual qigong exercise twice a week and for 12 weeks,whereas control group (n = 16) was involved in cognitive training activities with mobilization elements. The psychosocial, physical, and neurobiological outcomes of the two groups were compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

June 26, 2018

Last Update Submit

July 29, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Health Questionnaire (PHQ)

    Patient Health Questionnaire (PHQ) is used to assess the experience of depressive symptoms. The frequency of each symptom was indicated based on a 4-point scale (0 = never; 3 = almost every day). A total score ranged from 0 to 27 can be derived, with higher score indicating severer depressive symptoms.

    the change from baseline to the completion of intervention (12 weeks later)

Secondary Outcomes (9)

  • Salivary Cortisol Level

    baseline and 12 weeks after baseline

  • Brain Deprived Neurotrophic Factor (BDNF) Level

    baseline and 12 weeks after baseline

  • Serotonin 5-HT Level

    baseline and 12 weeks after baseline

  • Depression Anxiety Stress Scale (DASS-21)

    baseline, 12 weeks after baseline, and 16 weeks after baseline

  • Personal Well-Being Index (PWI)

    baseline, 12 weeks after baseline, and 16 weeks after baseline

  • +4 more secondary outcomes

Study Arms (2)

Qigong Training

EXPERIMENTAL
Behavioral: Qigong Training

Cognitive Training

ACTIVE COMPARATOR
Behavioral: Cognitive Training

Interventions

Qigong TrainingBEHAVIORAL

Eight-Section Brocades; participants were trained individually.

Qigong Training

Cognitive Training of Memory and Executive Function with Activities requiring Mobilization

Cognitive Training

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechinic University

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Chronic DiseaseDepression

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head of Department of Rehabilitation Sciences

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 19, 2018

Study Start

August 1, 2017

Primary Completion

January 31, 2018

Study Completion

February 28, 2018

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations