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

Abstract

IntroductionQigong 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 analysisA 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 disseminationThis 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.Trial registration numberChiCTR1800016570.

Long-Term Wu Qin Xi Exercise on Response Inhibition and Cortical Connectivity in Parkinson's Disease: Design and Implementation of a Randomized Controlled Clinical Trial

“…The format will be modeled after the experimental exercise format, including a 10-min warm-up, a 60-min exercise period with a 10-min break after the first 30 min, and 10-min cooldown (limb range-of-motion movements, sustained stretching, and relaxing). The balance training will consist of: (1) static balancing on unstable surfaces with the maintenance of postural control and progression to weight shifting; (2) dynamic balancing with postural control while standing and performing upper-limb and trunk movements; (3) balance strategy development with a focus on the hips while maintaining ankle balance, including stepping in different directions under interference; (4) and adaptation to varying bases of support and standing in a narrow space and on an uneven surface ( 31 , 32 ).…”

“…The task will consist of randomly interleaved no-go and stop-signal trials, enabling us to examine both types of inhibition ( 32 ). A total of 480 trials (75% go, 17% stop, and 8% no-go) will be administered ( Figure 4 ).…”

“…PD participants in the balance exercise control group will attend a supervised balance exercise program of the same frequency, duration, and session length as the Wu Qin Xi groups. The (31,32).…”

Tai Chi, Qigong and the Treatment of Disease

“…Several studies found that the practice of qigong exercises can have a positive effect motor function, walking ability and balance for individuals having Parkinson's disease [121][122][123][124][125][126].…”

Effects of Health Qigong Exercises on Physical Function on Patients with Parkinson’s Disease

“… 22 Li et al found that Health Qigong practice improved the ability to focus on the postural stability, and can enhance core muscle to stress weight-bearing joints and to increase proprioception input of trunk and lower limb joints. 23 Others showed that Health Qigong exercise relieved sleep disorders and non-motor symptoms in patients with PD. 24 The effect of Health Qigong on the mechanism of PD has attracted extensive attention from researchers worldwide.…”