Clinical trial NCT04430309: Baduanjin on Patients With Schizophrenia
Official title: The Feasibility and Efficacy of Baduanjin Exercise on Cognition and Physical Fitness Among Patients With Schizophrenia:Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia, mind body intervention ,Baduanjin
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: National Taiwan University
First posted: 2020-06-12
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change scores of 6-minute walk test
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of 30-second chair stand test
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of Timed up-and-go test
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of Montreal cognitive assessment
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of Trail making test (part A and part B)
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of Logical Memory
timeFrame: Baseline, immediate after treatment, 4-week follow up
Secondary outcomes:
measure: Change scores of dual task Timed up-and-go test (manual)
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of dual task Timed up-and-go test (cognitive)
timeFrame: Baseline, immediate after treatment, 4-week follow up
measure: Change scores of Activities of Daily Living Rating Scale III
timeFrame: Baseline, immediate after treatment, 4-week follow up
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital, Kaohsiung Medical Center
Study officials:
References: