Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trial

Introduction: Negative symptoms and cognitive impairment are common residual symptoms of schizophrenia that seriously affect the quality of life and social function of patients. The intervention of residual symptoms is an important part of schizophrenia rehabilitation. Traditional Chinese exercise h...

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Main Authors: Anbei Lian, Qing Fan, Wenzheng Wang, Qinxin Liu, Jiacheng Shi, Min Zhuang, Yujie Li, Xiaodan Liu
Format: Article
Language:English
Published: Elsevier 2023-12-01
Series:Contemporary Clinical Trials Communications
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865423001606
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author Anbei Lian
Qing Fan
Wenzheng Wang
Qinxin Liu
Jiacheng Shi
Min Zhuang
Yujie Li
Xiaodan Liu
author_facet Anbei Lian
Qing Fan
Wenzheng Wang
Qinxin Liu
Jiacheng Shi
Min Zhuang
Yujie Li
Xiaodan Liu
author_sort Anbei Lian
collection DOAJ
description Introduction: Negative symptoms and cognitive impairment are common residual symptoms of schizophrenia that seriously affect the quality of life and social function of patients. The intervention of residual symptoms is an important part of schizophrenia rehabilitation. Traditional Chinese exercise has been applied as a supplementary rehabilitation method for schizophrenia. However, research on its use and pertinence in the rehabilitation of residual symptoms remains lacking. In this study, we will verify the intervention effect of a new method, namely, shen-based qigong exercise, on the residual symptoms of schizophrenia, in the hopes of finding a safe and effective rehabilitation method for the residual symptoms of schizophrenia. Methods: This is a single-centre randomised controlled trial. A total of 60 schizophrenics who meet the criteria will be randomly divided into the control and intervention groups in accordance with the ratio of 1:1. Conventional drug treatment will remain unchanged in both groups. In this case, the control group will be given daily rehabilitation, whereas the intervention group will be given daily rehabilitation and shen-based qigong exercise intervention. The intervention period will be 12 weeks. The primary outcome will be negative symptoms assessed by the Scale for the Assessment of Negative Symptoms. The secondary outcome will be the global cognitive function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status and event-related potential P300. Other outcomes will include specific cognitive domain (i.e. working memory), quality of life and social function. The results will be measured within 1 week before and after the intervention. Discussion: The results of this study will likely help find an economical and convenient rehabilitation method for the residual symptoms of schizophrenia and, at the same time, may promote the popularisation and application of traditional Chinese exercises and traditional Chinese medicine theories in the treatment of mental diseases. Trial registration: ClinicalTrials.gov registry number: NCT05310955.
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spelling doaj.art-3a72063ac6a8431094853de618bc92ee2023-12-16T06:08:35ZengElsevierContemporary Clinical Trials Communications2451-86542023-12-0136101214Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trialAnbei Lian0Qing Fan1Wenzheng Wang2Qinxin Liu3Jiacheng Shi4Min Zhuang5Yujie Li6Xiaodan Liu7Department of Occupational Therapy, Shanghai YangZhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), Shanghai, ChinaShanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Institute of Traditional Chinese Medicine for Mental Health, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, ChinaShanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaShanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaSchool of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, ChinaDepartment of Rehabilitation, Huashan Hospital Fudan University, Shanghai, ChinaSchool of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China; Department of Psychiatric Rehabilitation, Wuxi Mental Health Centre, Wuxi, ChinaSchool of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China; Engineering Research Center of Intelligent Rehabilitation of Traditional Chinese Medicine, Ministry of Education, Shanghai University of Traditional Chinese Medicine, Shanghai, China; Corresponding author. Building 10, No. 1200 Cailun Road, Pudong New Distinct, Shanghai, 201203, China.Introduction: Negative symptoms and cognitive impairment are common residual symptoms of schizophrenia that seriously affect the quality of life and social function of patients. The intervention of residual symptoms is an important part of schizophrenia rehabilitation. Traditional Chinese exercise has been applied as a supplementary rehabilitation method for schizophrenia. However, research on its use and pertinence in the rehabilitation of residual symptoms remains lacking. In this study, we will verify the intervention effect of a new method, namely, shen-based qigong exercise, on the residual symptoms of schizophrenia, in the hopes of finding a safe and effective rehabilitation method for the residual symptoms of schizophrenia. Methods: This is a single-centre randomised controlled trial. A total of 60 schizophrenics who meet the criteria will be randomly divided into the control and intervention groups in accordance with the ratio of 1:1. Conventional drug treatment will remain unchanged in both groups. In this case, the control group will be given daily rehabilitation, whereas the intervention group will be given daily rehabilitation and shen-based qigong exercise intervention. The intervention period will be 12 weeks. The primary outcome will be negative symptoms assessed by the Scale for the Assessment of Negative Symptoms. The secondary outcome will be the global cognitive function assessed by the Repeatable Battery for the Assessment of Neuropsychological Status and event-related potential P300. Other outcomes will include specific cognitive domain (i.e. working memory), quality of life and social function. The results will be measured within 1 week before and after the intervention. Discussion: The results of this study will likely help find an economical and convenient rehabilitation method for the residual symptoms of schizophrenia and, at the same time, may promote the popularisation and application of traditional Chinese exercises and traditional Chinese medicine theories in the treatment of mental diseases. Trial registration: ClinicalTrials.gov registry number: NCT05310955.http://www.sciencedirect.com/science/article/pii/S2451865423001606SchizophreniaQigongRehabilitationRandomised controlled trialClinical trial protocol
spellingShingle Anbei Lian
Qing Fan
Wenzheng Wang
Qinxin Liu
Jiacheng Shi
Min Zhuang
Yujie Li
Xiaodan Liu
Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trial
Contemporary Clinical Trials Communications
Schizophrenia
Qigong
Rehabilitation
Randomised controlled trial
Clinical trial protocol
title Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trial
title_full Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trial
title_fullStr Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trial
title_full_unstemmed Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trial
title_short Effect of 12-week shen-based qigong exercise on the residual symptoms of schizophrenia: Study protocol for a single-centre randomised controlled trial
title_sort effect of 12 week shen based qigong exercise on the residual symptoms of schizophrenia study protocol for a single centre randomised controlled trial
topic Schizophrenia
Qigong
Rehabilitation
Randomised controlled trial
Clinical trial protocol
url http://www.sciencedirect.com/science/article/pii/S2451865423001606
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