Analysis of health Qigong-related clinical trial registration characteristics and reporting quality_Chinese Journal of Evidence-Based Medicine

Authors：

ZHOU Jun ¹ , LI Lanxuan ² , DENG Wei ³ , TANG Yue ⁴ , HAN Xiaoman ⁴ , ZHOU Qizhi ¹ ,  LIANG Fanrong ¹

1. College of Acupuncture and Massage, Chengdu University of TCM, Chengdu 610075, P.R.China;
2. College of Clinical Medicine, Chengdu University of TCM, Chengdu 610075, P.R.China;
3. Chengdu College of Sichuan Foreign Studies University, Chengdu 611844, P.R.China;
4. School of Chinese Martial Arts, Beijing Sports University, Beijing 100084, P.R.China;

Corresponding?author：

LIANG Fanrong, Email: acuresearch@126.com

Keywords：

Health Qigong; Clinical research; Registration characteristics; Chinese Clinical Trial Registry (ChiCTR); Reporting quality

DOI：

10.7507/1672-2531.202006116

Video：

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Objective To analyze the characteristics and reporting quality of the registered health Qigong-related clinical trials, and to analyze the progress and shortcomings of health Qigong-related clinical trials.Methods Chinese Clinical Trial Registry (ChiCTR) and ClinicalTrials.gov were electronically searched to collect the health Qigong-related clinical trials from inception to October 15^st, 2020. Characteristics of trials were analyzed in the aspects of basic information, funding source, study content and more. The quality of registration was evaluated by WHO Trial Registration Data Set (TRDS).Results A total of 121 registered clinical trials were included. The annual registration quantity has been increasing with a peak (33.06%) reached in 2020. Among the registered trials, Baduanjin exercise- related studies accounted for the highest proportion (65.29%). The quantity of studies registered in Shanghai accounted for the most (29.75%). The largest contribution of registered trials was from Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine (5.79%). 50.83% funds in trials were originated from universities and hospitals. Type 2 diabetes, and chronic obstructive pulmonary disease were the most studied diseases in the registered trials. 90.08% trials were designed as randomised parallel control studies, and the sample sizes of trials were concentrated between 30 and 100 (71.07%), and the age of the subjects was distributed over 40 years old (46.15%). The average quality of registration completion of the two registries was 87.44%.Conclusions At present, the general trend of health Qigong clinical research is positive. However, these trials contain unbalanced attributes such as the research type of health Qigong, distribution of registration area and organization, allocation of funds, and age composition of subjects. The design of clinical trials and registration details are needed to be improved.

Citation： ZHOU Jun, LI Lanxuan, DENG Wei, TANG Yue, HAN Xiaoman, ZHOU Qizhi, LIANG Fanrong. Analysis of health Qigong-related clinical trial registration characteristics and reporting quality. Chinese Journal of Evidence-Based Medicine, 2021, 21(2): 197-203. doi: 10.7507/1672-2531.202006116 Copy

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2.	肖素霞. 健康中國背景下高等醫學院校推廣健身氣功的可行性研究. 武術研究, 2018, 3(2): 103-105.
3.	GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet, 2018, 392(10159): 1789-1858.
4.	Wang CC, Li K, Choudhury A, et al. Trends in Yoga, Tai Chi, and Qigong Use Among US Adults, 2002-2017. Am J Public Health, 2019, 109(5): 755-761.
5.	Zheng G, Huang M, Li S, et al. Effect of Baduanjin exercise on cognitive function in older adults with mild cognitive impairment: study protocol for a randomised controlled trial. BMJ Open, 2016, 6(4): e010602.
6.	范銅鋼, 虞定海. 傳統體育養生功法技術活化的歷史、現狀與未來. 上海體育學院學報, 2019, 43(6): 96-103.
7.	于華榮, 趙金娜, 王利, 等. 健身氣功防治疾病的應用現狀及理論探討. 山東中醫雜志, 2019, 38(2): 11-15.
8.	Sun GC, Lovejoy JC, Gillham S, et al. Effects of Qigong on glucose control in type 2 diabetes: a randomized controlled pilot study. Diabetes Care, 2010, 33(1): e8.
9.	Xiong X, Wang P, Li S, et al. Effect of Baduanjin exercise for hypertension: a systematic review and meta-analysis of randomized controlled trials. Maturitas, 2015, 80(4): 370-378.
10.	Lee MS, Pittler MH, Ernst E. External qigong for pain conditions: a systematic review of randomized clinical trials. J Pain, 2007, 8(11): 827-831.
11.	Xiao CM, Li JJ, Kang Y, et al. Follow-up of a Wuqinxi exercise at home programme to reduce pain and improve function for knee osteoarthritis in older people: a randomised controlled trial. Age Ageing, 2020, online ahead of print.
12.	Oh B, Butow P, Mullan B, et al. Impact of medical Qigong on quality of life, fatigue, mood and inflammation in cancer patients: a randomized controlled trial. Ann Oncol, 2010, 21(3): 608-614.
13.	Wang K, Liu SJ, Kong ZW, et al. Mind-body exercise (Wuqinxi) for patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis of randomized controlled trials. Int J Environ Res Public Health, 2018, 16(1): 1-12.
14.	Wu W, Liu X, Liu J, et al. Effectiveness of water-based Liuzijue exercise on respiratory muscle strength and peripheral skeletal muscle function in patients with COPD. Int J Chron Obstruct Pulmon Dis, 2018, 13: 1713-1726.
15.	Chan JS, Li A, Ng SM, et al. Adiponectin potentially contributes to the antidepressive effects of Baduanjin Qigong exercise in women with chronic fatigue syndrome-like illness. Cell Transplant, 2017, 26(3): 493-501.
16.	Chen MC, Liu HE, Huang HY, et al. The effect of a simple traditional exercise programme (Baduanjin exercise) on sleep quality of older adults: a randomized controlled trial. Int J Nurs Stud, 2012, 49(3): 265-273.
17.	Liu X, Miller YD, Burton NW, et al. A preliminary study of the effects of Tai Chi and Qigong medical exercise on indicators of metabolic syndrome, glycaemic control, health-related quality of life, and psychological health in adults with elevated blood glucose. Br J Sports Med, 2010, 44(10): 704-709.
18.	Chen HH, Yeh ML, Lee FY. The effects of Baduanjin qigong in the prevention of bone loss for middle-aged women. Am J Chin Med, 2006, 34(5): 741-747.
19.	Wei X, Xu A, Yin Y, et al. The potential effect of Wuqinxi exercise for primary osteoporosis: a systematic review and meta-analysis. Maturitas, 2015, 82(4): 346-354.
20.	Hsu MC, Wang TS, Liu YP, et al. Effects of Baduanjin exercise on oxidative stress and antioxidant status and improving quality of life among middle-aged women. Am J Chin Med, 2008, 36(5): 815-826.
21.	Takashi S, Tibor H, Azusa U, et al. Long-term Qigong practice is associated with improved self-perceived health and quality of life. Int J Sport Exercise Psychol, 2020, 18(3): 1-13.
22.	Chen X, Cui J, Li R, et al. Dao Yin (a.k.a. Qigong): origin, development, potential mechanisms, and clinical applications. Evid Based Complement Alternat Med, 2019, 2019(3): 1-11.
23.	穆長帥, 王震. 從經絡學說的視角探研健身氣功·馬王堆導引術的健身原理. 中國運動醫學雜志, 2011, 30(2): 189-191.
24.	戴薇. 四川省健身氣功可持續發展策略研究. 內江師范學院學報, 2012, 27(12): 117-120.
25.	楊晗, 李涓, 李雨谿, 等. 針灸治療中風后痙攣性癱瘓的系統評價再評價. 中國循證醫學雜志, 2019, 19(10): 1233-1239.
26.	WHO Trial Registration Data Set (TRDS). Available at: https://www.who.int/ictrp/network/trds/zh/.
27.	吳泰相, 郝園, 孔翔瑜, 等. 中國臨床試驗注冊 10 年: 現狀與問題. 中國循證醫學雜志, 2018, 18(6): 522-525.
28.	虞定海, 李衛民. 上海市健身氣功發展戰略研究. 上海體育學院學報, 2005, 29(2): 72-77.
29.	Sander M, Oxlund B, Jespersen A, et al. The challenges of human population ageing. Age Ageing, 2015, 44(2): 185-187.
30.	楊晗, 李涓, 徐桂興, 等. 國際近 15 年太極拳研究的文獻計量及可視化分析. 中國康復醫學雜志, 2020, 35(3): 327-332.
31.	崔永勝, 楊慧馨. 健身氣功習練人群特征調查分析. 體育文化導刊, 2017, 17(6): 42-46.
32.	Tao J, Liu J, Liu W, et al. Tai Chi Chuan and Baduanjin Increase Grey Matter Volume in Older Adults: A Brain Imaging Study. J Alzheimers Dis, 2017, 60(2): 389-400.
33.	Liu J, Tao J, Liu W, et al. Different modulation effects of Tai Chi Chuan and Baduanjin on resting-state functional connectivity of the default mode network in older adults. Soc Cogn Affect Neurosci, 2019, 14(2): 217-224.
34.	Tao J, Chen X, Egorova N, et al. Tai Chi Chuan and Baduanjin practice modulates functional connectivity of the cognitive control network in older adults. Sci Rep, 2017, 7: 41581.
35.	Duarte L, Gon?alves M, Mendes P, et al. Can Qigong improve attention in adolescents? A prospective randomised controlled trial. J Bodyw Mov Ther, 2020, 24(1): 175-181.
36.	P?l?nen P, Lappi O, Tervaniemi M. Effect of meditative movement on affect and flow in qigong practitioners. Front Psychol, 2019, 10: 2375.
37.	Li M, Fang Q, Li J, et al. The effect of Chinese traditional exercise-Baduanjin on physical and psychological well-being of college students: a randomized controlled trial. PLoS One, 2015, 10(7): e0130544.

1. 國家體育總局健身氣功管理中心. 健身氣功社會體育指導員培訓教材. 北京: 人民體育出版社, 2007, 10: 4.
2. 肖素霞. 健康中國背景下高等醫學院校推廣健身氣功的可行性研究. 武術研究, 2018, 3(2): 103-105.
3. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet, 2018, 392(10159): 1789-1858.
4. Wang CC, Li K, Choudhury A, et al. Trends in Yoga, Tai Chi, and Qigong Use Among US Adults, 2002-2017. Am J Public Health, 2019, 109(5): 755-761.
5. Zheng G, Huang M, Li S, et al. Effect of Baduanjin exercise on cognitive function in older adults with mild cognitive impairment: study protocol for a randomised controlled trial. BMJ Open, 2016, 6(4): e010602.
6. 范銅鋼, 虞定海. 傳統體育養生功法技術活化的歷史、現狀與未來. 上海體育學院學報, 2019, 43(6): 96-103.
7. 于華榮, 趙金娜, 王利, 等. 健身氣功防治疾病的應用現狀及理論探討. 山東中醫雜志, 2019, 38(2): 11-15.
8. Sun GC, Lovejoy JC, Gillham S, et al. Effects of Qigong on glucose control in type 2 diabetes: a randomized controlled pilot study. Diabetes Care, 2010, 33(1): e8.
9. Xiong X, Wang P, Li S, et al. Effect of Baduanjin exercise for hypertension: a systematic review and meta-analysis of randomized controlled trials. Maturitas, 2015, 80(4): 370-378.
10. Lee MS, Pittler MH, Ernst E. External qigong for pain conditions: a systematic review of randomized clinical trials. J Pain, 2007, 8(11): 827-831.
11. Xiao CM, Li JJ, Kang Y, et al. Follow-up of a Wuqinxi exercise at home programme to reduce pain and improve function for knee osteoarthritis in older people: a randomised controlled trial. Age Ageing, 2020, online ahead of print.
12. Oh B, Butow P, Mullan B, et al. Impact of medical Qigong on quality of life, fatigue, mood and inflammation in cancer patients: a randomized controlled trial. Ann Oncol, 2010, 21(3): 608-614.
13. Wang K, Liu SJ, Kong ZW, et al. Mind-body exercise (Wuqinxi) for patients with chronic obstructive pulmonary disease: a systematic review and meta-analysis of randomized controlled trials. Int J Environ Res Public Health, 2018, 16(1): 1-12.
14. Wu W, Liu X, Liu J, et al. Effectiveness of water-based Liuzijue exercise on respiratory muscle strength and peripheral skeletal muscle function in patients with COPD. Int J Chron Obstruct Pulmon Dis, 2018, 13: 1713-1726.
15. Chan JS, Li A, Ng SM, et al. Adiponectin potentially contributes to the antidepressive effects of Baduanjin Qigong exercise in women with chronic fatigue syndrome-like illness. Cell Transplant, 2017, 26(3): 493-501.
16. Chen MC, Liu HE, Huang HY, et al. The effect of a simple traditional exercise programme (Baduanjin exercise) on sleep quality of older adults: a randomized controlled trial. Int J Nurs Stud, 2012, 49(3): 265-273.
17. Liu X, Miller YD, Burton NW, et al. A preliminary study of the effects of Tai Chi and Qigong medical exercise on indicators of metabolic syndrome, glycaemic control, health-related quality of life, and psychological health in adults with elevated blood glucose. Br J Sports Med, 2010, 44(10): 704-709.
18. Chen HH, Yeh ML, Lee FY. The effects of Baduanjin qigong in the prevention of bone loss for middle-aged women. Am J Chin Med, 2006, 34(5): 741-747.
19. Wei X, Xu A, Yin Y, et al. The potential effect of Wuqinxi exercise for primary osteoporosis: a systematic review and meta-analysis. Maturitas, 2015, 82(4): 346-354.
20. Hsu MC, Wang TS, Liu YP, et al. Effects of Baduanjin exercise on oxidative stress and antioxidant status and improving quality of life among middle-aged women. Am J Chin Med, 2008, 36(5): 815-826.
21. Takashi S, Tibor H, Azusa U, et al. Long-term Qigong practice is associated with improved self-perceived health and quality of life. Int J Sport Exercise Psychol, 2020, 18(3): 1-13.
22. Chen X, Cui J, Li R, et al. Dao Yin (a.k.a. Qigong): origin, development, potential mechanisms, and clinical applications. Evid Based Complement Alternat Med, 2019, 2019(3): 1-11.
23. 穆長帥, 王震. 從經絡學說的視角探研健身氣功·馬王堆導引術的健身原理. 中國運動醫學雜志, 2011, 30(2): 189-191.
24. 戴薇. 四川省健身氣功可持續發展策略研究. 內江師范學院學報, 2012, 27(12): 117-120.
25. 楊晗, 李涓, 李雨谿, 等. 針灸治療中風后痙攣性癱瘓的系統評價再評價. 中國循證醫學雜志, 2019, 19(10): 1233-1239.
26. WHO Trial Registration Data Set (TRDS). Available at: https://www.who.int/ictrp/network/trds/zh/.
27. 吳泰相, 郝園, 孔翔瑜, 等. 中國臨床試驗注冊 10 年: 現狀與問題. 中國循證醫學雜志, 2018, 18(6): 522-525.
28. 虞定海, 李衛民. 上海市健身氣功發展戰略研究. 上海體育學院學報, 2005, 29(2): 72-77.
29. Sander M, Oxlund B, Jespersen A, et al. The challenges of human population ageing. Age Ageing, 2015, 44(2): 185-187.
30. 楊晗, 李涓, 徐桂興, 等. 國際近 15 年太極拳研究的文獻計量及可視化分析. 中國康復醫學雜志, 2020, 35(3): 327-332.
31. 崔永勝, 楊慧馨. 健身氣功習練人群特征調查分析. 體育文化導刊, 2017, 17(6): 42-46.
32. Tao J, Liu J, Liu W, et al. Tai Chi Chuan and Baduanjin Increase Grey Matter Volume in Older Adults: A Brain Imaging Study. J Alzheimers Dis, 2017, 60(2): 389-400.
33. Liu J, Tao J, Liu W, et al. Different modulation effects of Tai Chi Chuan and Baduanjin on resting-state functional connectivity of the default mode network in older adults. Soc Cogn Affect Neurosci, 2019, 14(2): 217-224.
34. Tao J, Chen X, Egorova N, et al. Tai Chi Chuan and Baduanjin practice modulates functional connectivity of the cognitive control network in older adults. Sci Rep, 2017, 7: 41581.
35. Duarte L, Gon?alves M, Mendes P, et al. Can Qigong improve attention in adolescents? A prospective randomised controlled trial. J Bodyw Mov Ther, 2020, 24(1): 175-181.
36. P?l?nen P, Lappi O, Tervaniemi M. Effect of meditative movement on affect and flow in qigong practitioners. Front Psychol, 2019, 10: 2375.
37. Li M, Fang Q, Li J, et al. The effect of Chinese traditional exercise-Baduanjin on physical and psychological well-being of college students: a randomized controlled trial. PLoS One, 2015, 10(7): e0130544.

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