Study protocol for a single-blind randomised controlled trial to evaluate the clinical effects of an Integrated Qigong exercise intervention on freezing of gait in Parkinson's disease.

Author: Li Z1, Zhuang J2, Jiang Y1, Xiao G1, Jie K1, Wang T1, Yin W1, Zhang Y3, Wang Z2
1School of Sport Science, School of Martial Arts, Shanghai University of Sport, Shanghai, China.
2School of Sport Science, School of Martial Arts, Shanghai University of Sport, Shanghai, China
3Department of Neurology, Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China.
Conference/Journal: BMJ Open.
Date published: 2019 Sep 12
Other: Volume ID: 9 , Issue ID: 9 , Pages: e028869 , Special Notes: doi: 10.1136/bmjopen-2018-028869. , Word Count: 322

INTRODUCTION: Qigong exercise offers a potentially safe, low-cost and effective mind-body rehabilitative intervention for mitigating the problem of gait interruption among patients with Parkinson's disease (PD) who have frequent freezing of gait (FOG) episodes. However, its clinical effects have not been established. This paper describes the trial protocol of evaluating the clinical efficacy of a newly developed Integrated Qigong in improving gait among patients with PD who have FOG.

METHODS AND ANALYSIS: A single-blind randomised controlled trial is designed to compare Integrated Qigong and balance training with an attention control. Participants will be patients with mild to moderate PD who experience FOG and are recruited from local communities in Shanghai, China. Participants will be randomly allocated to one of the three groups: Integrated Qigong group, a balance exercise intervention group, or control group. The total number of participants will be 126, and masked assessments will be made at baseline, 12 weeks (end of intervention) and 12-week follow-up. Both Integrated Qigong group and balance training group will receive a group-based exercise intervention that meets three times per week, 60 min in duration, for 12 weeks. The control group will receive a 60 min weekly group session and monthly health education. The primary outcomes are gait parameters (stride length, gait velocity, stride time variability) and occurrence of FOG. The secondary outcomes are postural instability, walking disability, falling, fear of falling and quality of life.

ETHICS AND DISSEMINATION: This study has been approved by the Ethics Committee of Shanghai University of Sport and registered at China Clinical Trial Registry. Participants will sign informed consent prior to the participation of the trial. The findings of the study will be published in peer-reviewed academic journals and disseminated to PD support groups, medical community and media.


© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

KEYWORDS: exercise; gait interruption; movement disorder; neurodegenerative disease

PMID: 31515419 DOI: 10.1136/bmjopen-2018-028869