NCT04430309

Brief Summary

As an ancient, popular Chinese exercise, Baduanjin is characterized by symmetrical posture, deep breathing and meditation and easy to learn. Previous studies showed immediate effect of Baduanjin on cognition in patients with schizophrenia.The purpose of this study is to investigate the immediate effect and chronic effect of Baduanjin exercise on physical fitness, cognition and daily functions in middle-aged and older adults with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable schizophrenia

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

First Submitted

Initial submission to the registry

June 3, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

April 10, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

1.2 years

First QC Date

June 3, 2020

Last Update Submit

May 25, 2025

Conditions

Keywords

Schizophrenia, mind body intervention ,Baduanjin

Outcome Measures

Primary Outcomes (6)

  • Change scores of 6-minute walk test

    This test evaluates cardiovascular fitness and walking speed.

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of 30-second chair stand test

    This test evaluates muscular endurance of lower-extremities.

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of Timed up-and-go test

    This test evaluates functional mobility, agility and balance

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of Montreal cognitive assessment

    This test evaluates global cognition.

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of Trail making test (part A and part B)

    This test evaluates speed of processing, visual attention and cognitive flexibility.

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of Logical Memory

    It is a subtest of the Wechsler Memory Scale. This test evaluates memory.

    Baseline, immediate after treatment, 4-week follow up

Secondary Outcomes (3)

  • Change scores of dual task Timed up-and-go test (manual)

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of dual task Timed up-and-go test (cognitive)

    Baseline, immediate after treatment, 4-week follow up

  • Change scores of Activities of Daily Living Rating Scale III

    Baseline, immediate after treatment, 4-week follow up

Study Arms (2)

Baduanjin exercise group

EXPERIMENTAL

The intervention group will practice Badunjin in a group which include 6-8 participants and one trained medical staff. The Baduanjin is an ancient Chinese mind-body exercise, which comprised of eight simple movements. The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks

Behavioral: Baduanjin exercise program

Control group

ACTIVE COMPARATOR

The control group will receive brisk walking activities. The sessions will take place twice a week, 60 minutes per session for a total duration of 12 weeks

Behavioral: Brisk walking program

Interventions

The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.

Also known as: Eight Silken Movements, Eight Silk Weaving
Baduanjin exercise group

The sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down.

Control group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a diagnosis of schizophrenia according to the DSM-5.
  • Independent adult aged 40 years or older in the day-care center.
  • Having a stable mental status without shift in medication and keep in same dose for at least one month.

You may not qualify if:

  • Serious physical conditions that will impede participation, such as cardiovascular disease, musculoskeletal disease or pulmonary system disease.
  • Visual or auditory impairment that precludes completion of assessment.
  • Acute psychosis requiring hospitalization.
  • Presence of severe withdrawal or profound cognitive disability that cause difficulties in following instructions.
  • Participating in another clinical trial at the same time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital, Kaohsiung Medical Center

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 12, 2020

Study Start

April 10, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

May 30, 2025

Record last verified: 2025-05

Locations