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

Author: Anbei Lian1, Qing Fan2,3,4, Wenzheng Wang2, Qinxin Liu2, Jiacheng Shi5, Min Zhuang6, Yujie Li5,7, Xiaodan Liu5,8
1 Department of Occupational Therapy, Shanghai YangZhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center), Shanghai, China.
2 Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
3 Shanghai Institute of Traditional Chinese Medicine for Mental Health, Shanghai, China.
4 Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.
5 School of Rehabilitation Science, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
6 Department of Rehabilitation, Huashan Hospital Fudan University, Shanghai, China.
7 Department of Psychiatric Rehabilitation, Wuxi Mental Health Centre, Wuxi, China.
8 Engineering Research Center of Intelligent Rehabilitation of Traditional Chinese Medicine, Ministry of Education, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Conference/Journal: Contemp Clin Trials Commun
Date published: 2023 Oct 3
Other: Volume ID: 36 , Pages: 101214 , Special Notes: doi: 10.1016/j.conctc.2023.101214. , Word Count: 317

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.

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.

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.

Keywords: Clinical trial protocol; Qigong; Randomised controlled trial; Rehabilitation; Schizophrenia.

PMID: 37842323 PMCID: PMC10568084 DOI: 10.1016/j.conctc.2023.101214