Abstract

Background: Non-motor symptoms such as sleep disturbance, cognitive decline, fatigue, anxiety, and depression in Parkinson’s disease (PD) impact quality of life. Increased levels of pro-inflammatory cytokines in individuals with PD have been reported, which may contribute to non-motor symptoms. A mind-body exercise, Qigong, has demonstrated benefits across different medical conditions. However, a lack of evidence causes clinicians and patients to be uncertain about the effects of Qigong in individuals with PD. This study will examine the effects of Qigong on non-motor symptoms and inflammatory status in individuals with PD. Methods: Sixty individuals with PD will be recruited. Qigong and sham Qigong group (n = 30 for each) will receive a 12-week intervention. Participants will practice their assigned exercise at home (2×/day) and attend routinely group exercise meetings. Results: Clinical questionnaires and neuropsychological tests will measure non-motor symptoms including sleep quality (primary outcome). Biomarker assays will measure inflammatory status. A two-way mixed-design analysis of variance (ANOVA) will be utilized. Conclusions: This study may generate evidence for the benefits of Qigong on non-motor symptoms of PD and the effect on inflammatory status. Findings may lead to the development of a novel, safe, and cost-effective rehabilitation approach for individuals with PD.

Highlights

  • Parkinson’s disease (PD) is a neurodegenerative disorder leading to both motor and non-motor symptoms

  • In our feasibility study in a single-arm design (n = 7), a 6-week Qigong exercise program demonstrated an improvement in sleep quality measured by Parkinson’s Disease Sleep Scale-2 (PDSS-2), in which the results showed sub-scores of PDSS-2 were significantly improved or showed a trend of improvement including motor symptoms at night (p < 0.05)

  • Our recent pilot study suggested potential benefits of Qigong exercise through changes in inflammation status, in which the results showed a significant decrease in serum level of tumor necrosis factor (TNF)-α from 13.8 ± 0.6 to 12.3 ± 1.6 (p < 0.05) that was significantly correlated with changes in sleep quality and serum TNF-α level (R2 = 0.62) [18]

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Summary

A Protocol for a Randomized Controlled Trial

Smirnova 1 , Yvonne Colgrove 1 , Kelly E. Received: 2 December 2018; Accepted: 16 January 2019; Published: 18 January 2019

Conclusions
Introduction
Study Design
Specific Aims
Ethics Approval and Informed Consent
Inclusion Criteria
Exclusion Criteria
Recruitment and Screening
Informed Consent
Randomization and Double-Blinding
Experimental Group
Control Group
Adverse Events
Demographic and Clinical Information
Clinical Assessments
Serum Biomarkers
Sample Size Estimation
Statistical Analysis
Discussion
Are you between the ages of 40 and 75?
Can you be contacted for participation in the study within two weeks?
Full Text
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