Baduanjin on Patients With Schizophrenia

Sponsor
Chang Gung Memorial Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04430309
Collaborator
National Taiwan University (Other)
48
1
2
14.7
3.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Baduanjin exercise program
  • Behavioral: Brisk walking program
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Feasibility and Efficacy of Baduanjin Exercise on Cognition and Physical Fitness Among Patients With Schizophrenia:Randomized Controlled Trial
Actual Study Start Date :
Apr 10, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Baduanjin exercise group

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
The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.
Other Names:
  • Eight Silken Movements
  • Eight Silk Weaving
  • Active Comparator: Control group

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

    Outcome Measures

    Primary Outcome Measures

    1. Change scores of 6-minute walk test [Baseline, immediate after treatment, 4-week follow up]

      This test evaluates cardiovascular fitness and walking speed.

    2. Change scores of 30-second chair stand test [Baseline, immediate after treatment, 4-week follow up]

      This test evaluates muscular endurance of lower-extremities.

    3. Change scores of Timed up-and-go test [Baseline, immediate after treatment, 4-week follow up]

      This test evaluates functional mobility, agility and balance

    4. Change scores of Montreal cognitive assessment [Baseline, immediate after treatment, 4-week follow up]

      This test evaluates global cognition.

    5. Change scores of Trail making test (part A and part B) [Baseline, immediate after treatment, 4-week follow up]

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

    6. Change scores of Logical Memory [Baseline, immediate after treatment, 4-week follow up]

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

    Secondary Outcome Measures

    1. Change scores of dual task Timed up-and-go test (manual) [Baseline, immediate after treatment, 4-week follow up]

      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.

    2. Change scores of dual task Timed up-and-go test (cognitive) [Baseline, immediate after treatment, 4-week follow up]

      This test combine serial three counting and Timed up-and-go test simultaneously. It evaluates dual task performance.

    3. Change scores of Activities of Daily Living Rating Scale III [Baseline, immediate after treatment, 4-week follow up]

      It is a self-administered, paper-and-pencil test that evaluates daily functions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chang Gung Memorial Hospital, Kaohsiung Medical Center Kaohsiung Taiwan 833

    Sponsors and Collaborators

    • Chang Gung Memorial Hospital
    • National Taiwan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chang Gung Memorial Hospital
    ClinicalTrials.gov Identifier:
    NCT04430309
    Other Study ID Numbers:
    • 202000817B0
    First Posted:
    Jun 12, 2020
    Last Update Posted:
    Aug 3, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Chang Gung Memorial Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2021