Baduanjin on Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

The Feasibility and Efficacy of Baduanjin Exercise on Cognition and Physical Fitness Among Patients With Schizophrenia:Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04430309
• Other study ID #: 202000817B0
• Status: Recruiting
• Phase: N/A
• Start date: April 10, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2021
• Source: Chang Gung Memorial Hospital
• Contact: Chyi-Rong Chen, Master
• Phone: +886-7-7317123
• Email: ccr776[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A single-blind, 2-arm randomized controlled trial investigating the benefits of Baduanjin exercise on middle-aged and older patients with schizophrenia. A total of 48 participants will be assigned to either 12 weeks of 60-minute two sessions per week Baduanjin exercise group or a brisk walking group. Primary outcomes are physical fitness and cognition functions. Secondary outcomes are dual task performance and daily functions. Evaluation will be completed at baseline, immediately after treatment and 4-week follow up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Baduanjin exercise program
The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.
• Brisk walking program
The sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Kaohsiung Medical Center	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital	National Taiwan University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores of 6-minute walk test	This test evaluates cardiovascular fitness and walking speed.	Baseline, immediate after treatment, 4-week follow up
Primary	Change scores of 30-second chair stand test	This test evaluates muscular endurance of lower-extremities.	Baseline, immediate after treatment, 4-week follow up
Primary	Change scores of Timed up-and-go test	This test evaluates functional mobility, agility and balance	Baseline, immediate after treatment, 4-week follow up
Primary	Change scores of Montreal cognitive assessment	This test evaluates global cognition.	Baseline, immediate after treatment, 4-week follow up
Primary	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
Primary	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	Change scores of dual task Timed up-and-go test (manual)	This test requires carry a cup of water 3 cm from the top of the cup while performing the Timed up-and-go test. It evaluates dual task performance.	Baseline, immediate after treatment, 4-week follow up
Secondary	Change scores of dual task Timed up-and-go test (cognitive)	This test combine serial three counting and Timed up-and-go test simultaneously. It evaluates dual task performance.	Baseline, immediate after treatment, 4-week follow up
Secondary	Change scores of Activities of Daily Living Rating Scale III	It is a self-administered, paper-and-pencil test that evaluates daily functions	Baseline, immediate after treatment, 4-week follow up