NCT03591198

Brief Summary

Qigong exercise is beneficial for older adults with co-occurring chronic physical illness and depression in terms of psychological and physical outcomes. However, the effects on functional independence, sleep quality, and mobility of depressive older adults remain unclear. It is also important to replicate its benefits for subjective well-being and muscle strength. A randomized clinical trial was conducted among older adults who were aged 60 or above and with chronic medical conditions for one year. After random assignment, intervention group (n = 25) went through qigong exercise twice a week and for 12 weeks,whereas control group (n = 22) was involved in cognitive training activities with mobilization elements. The psychosocial and physical 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
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

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

October 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2017

Completed
1.1 years 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 20, 2018

Status Verified

July 1, 2018

Enrollment Period

1.5 years

First QC Date

June 26, 2018

Last Update Submit

July 18, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Personal Well-Being Index (PWI)

    It is measured by the 8-item scale of Personal Well-Being Index (PWI). Each item was rated according to an 11-point scale ranging from '0' (extremely dissatisfied) to '10' (extremely satisfied). An overall score of PWI score was the sum of all items. The overall score ranges from 0 to 110, with higher score indicating higher subjective well-being.

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

Secondary Outcomes (4)

  • Functional Independence Measure (FIM)

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

  • Pittsburgh Sleep Quality Index (PSQI)

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

  • Timed up and Go Test (TUG)

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

  • Handgrip Strength

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

Study Arms (2)

Qigong Training

EXPERIMENTAL
Behavioral: Qigong Training

Cognitive Training

ACTIVE COMPARATOR
Behavioral: Cognitive Training

Interventions

Qigong TrainingBEHAVIORAL

Eight-Section Brocades

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

October 1, 2015

Primary Completion

March 31, 2017

Study Completion

May 31, 2017

Last Updated

July 20, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations