Search JIM Advanced Search

Journal of Chinese Integrative Medicine ›› 2013, Vol. 11 ›› Issue (2): 140-146.doi: 10.3736/jintegrmed2013015

• Study Protocol • Previous Articles     Next Articles

Functional and psychosocial effects of pulmonary Daoyin on patients with COPD in China: Study protocol of a multicenter randomized controlled trial

Xue-qing Yua, Jian-sheng Lib(), Su-yun Lia, Yang Xieb, Ming-hang Wanga, Hai-long Zhangb, Hai-feng Wanga, Zhi-wan Wanga   

  1. a. Department of Respiratory Diseases, the First Affiliated Hospital, Henan University of Traditional Chinese Medicine, Zhengzhou 450000, Henan Province, China
    b. Institute of Geriatric Medicine, Henan University of Traditional Chinese Medicine, Zhengzhou 450008, Henan Province, China
  • Received:2012-11-30 Accepted:2012-12-18 Online:2013-03-10 Published:2013-03-15

Background

Chronic obstructive pulmonary disease (COPD) is a major public health problem worldwide. Pulmonary rehabilitation (PR) is an established intervention for the management of patients with COPD. Exercise training is an important part of PR, and its effectiveness in patients with COPD is well established. However, alternative methods of PR training such as Daoyin have not been appropriately studied. Hence, alternative forms of exercise training that require less exercise equipment and no specific training place should be evaluated. This paper describes the study protocol of a clinical trial that aims to determine if pulmonary Daoyin training will improve the exercise capacity and psychosocial function of patients with COPD in China.


Methods and design

A multicenter, randomized, controlled trial will be conducted. A total of 464 patients meeting the inclusion criteria will be enrolled into this study with 232 patients in each of the trial group and the control group. Based on patient education, patients in the trial group will receive pulmonary Daoyin and continue with their usual therapy for three months. In the control group, patients will continue with their usual therapy. The primary outcome measures are exercise capacity assessed by the six-minute walking distance test and lung function. Secondary outcomes include dyspnea and quality of life. Measurements will be taken at baseline (month 0) and after the study period (month 3).


Discussion

It is hypothesized that pulmonary Daoyin will have beneficial effects in improving exercise capacity and psychosocial function of patients with stable COPD, and will provide an alternative form of exercise training that is accessible for the large number of people with COPD.


Trial registration

This trial has been registered in ClinicalTrials.gov. The identifier is NCT01482000.

Key words: Chronic obstructive pulmonary disease, Daoyin, Randomized controlled trial, Study protocol

Figure 1

The graphical action of pulmonary daoyinA: Stand in relaxed and tranquil pose; B: Breathing in qi to Dantian; C: Recuperate the lung and kidney; D: Twisting the body and moving the hands; E: Knead the Shenshu point; F: Drawing in exercises with cultivating qi."

Figure 2

Order of events for this randomized controlled studyCOPD: chronic obstructive pulmonary disease; 6MWD: six-minute walking distance; CAT: COPD Assessment Test; SF-36: 36-item Short Form Health Survey."

[1] Raherison C, Girodet PO . Epidemiology of COPD[J]. Eur Respir Rev, 2009,18(114):213-221
doi: 10.1183/09059180.00003609
[2] Yin P, Zhang M, Li Y, Jiang Y, Zhao W . Prevalence of COPD and its association with socioeconomic status in China: findings from China Chronic Disease Risk Factor Surveillance 2007[J]. BMC Public Health, 2011,11:586
doi: 10.1186/1471-2458-11-586
[3] National Institutes of Health, National Heart, Lung and Blood Institute. Morbidity and mortality: 2012 chart book on cardiovascular, lung, and blood diseases. 2012: 19-20.
[4] Lacasse Y, Martin S, Lasserson TJ, Goldstein RS . Meta-analysis of respiratory rehabilitation in chronic obstructive pulmonary disease. A Cochrane systematic review[J]. Eura Medicophys, 2007,43(4):475-485
[5] Wehrmeister FC, Knorst M, Jardim JR, Macedo EC, Noal RB, Martínez-Mesa J, González DA, Dumith SC, Maia Mde F, Hallal PC, Menezes AM . Pulmonary rehabilitation programs for patients with COPD[J]. J Bras Pneumol, 2011,37(4):544-555
doi: 10.1590/S1806-37132011000400017
[6] Singh S, Harrison S, Houchen L, Wagg K . Exercise assessment and training in pulmonary rehabilitation for patients with COPD[J]. Eur J Phys Rehabil Med, 2011,47(3):483-497
[7] Nici L, Zuwallack R . Scope, background and definition of pulmonary rehabilitation[J]. Eur J Phys Rehabil Med, 2011,47(3):465-474
[8] Johnston K, Grimmer-Somers K . Pulmonary rehabilitation: overwhelming evidence but lost in translation? Physiother Can. 2010; 62(3):368-373.
doi: 10.3138/physio.62.4.368
[9] Zhang MW, Sun XY. Chinese Qiong therapy[M]. Jinan: Shandong Science and Technology Press, 1985, 6-7
[10] Tsang HW, Mok CK, Au Yeung YT, Chan SY . The effect of Qigong on general and psychosocial health of elderly with chronic physical illnesses: a randomized clinical trial[J]. Int J Geriatr Psychiatry, 2003,18(5):441-449
doi: 10.1002/(ISSN)1099-1166
[11] Ng BH, Tsang HW, Jones AY, So CT, Mok TY . Functional and psychosocial effects of health qigong in patients with COPD: a randomized controlled trial[J]. J Altern Complement Med, 2011,17(3):243-251
doi: 10.1089/acm.2010.0215
[12] Chan AW, Lee A, Suen LK, Tam WW . Tai chi Qigong improves lung functions and activity tolerance in COPD clients: a single blind, randomized controlled trial[J]. Complement Ther Med, 2011,19(1):3-11
doi: 10.1016/j.ctim.2010.12.007
[13] Yeh GY, Roberts DH, Wayne PM, Davis RB, Quilty MT, Phillips RS . Tai chi exercise for patients with chronic obstructive pulmonary disease: a pilot study[J]. Respir Care, 2010,55(11):1475-1482
[14] Leung RW, Alison JA , McKeough ZJ, Peters MJ.A study design to investigate the effect of short-form Sun-style Tai Chi in improving functional exercise capacity, physical performance, balance and health related quality of life in people with Chronic Obstructive Pulmonary Disease(COPD)[J]. Contemp Clin Trials, 2011,32(2):267-272
doi: 10.1016/j.cct.2010.11.006
[15] Global Initiative for Chronic Obstructive Lung Disease . “Global Strategy for the Diagnosis, Management, and Prevention of COPD”. .
[16] COPD Study Group of Chinese Society of Respiratory Disease. Treatment guidelines of chronic obstructive pulmonary disease(revised 2007)[J]. Zhonghua Jie He He Hu Xi Za Zhi, 2007,30(1):8-17
[17] ATS. ATS Statement: Guidelines for the Six-Minute Walk Test[J]. Am J Respir Crit Care Med, 2002,166(1):111-117
doi: 10.1164/ajrccm.166.1.at1102
[18] Fletcher CM, Elmes PC, Fairbairn MB, Wood CH . The significance of respiratory symptoms and the diagnosis of chronic bronchitis in a working population[J]. BMJ, 1959,2(5147):257-266
doi: 10.1136/bmj.2.5147.257
[19] Mahler DA, Well CK . Evaluation of clinical methods for rating dyspnea[J]. Chest, 1988,93(3):580-586
doi: 10.1378/chest.93.3.580
[20] Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N . Development and first validation of the COPD Assessment Test[J]. Eur Respir J, 2009,34(3):648-654
doi: 10.1183/09031936.00102509
[21] Li L, Wang HM, Shen Y . Chinese SF-36 Health Survey: translation, cultural adaptation, validation, and normalization[J]. J Epidemiol Community Health, 2003,57(4):259-263
doi: 10.1136/jech.57.4.259
[22] Brooks D, Sottana R, Bell B, Hanna M, Laframboise L, Selvanayagarajah S, Goldstein R . Characterization of pulmonary rehabilitation programs in Canada in 2005[J]. Can Respir J, 2007,14(2):87-92
doi: 10.1155/2007/951498
[23] Vieira DS, Maltais F, Bourbeau J . Home-based pulmonary rehabilitation in chronic obstructive pulmonary disease patients[J]. Curr Opin Pulm Med, 2010,16(2):134-143
doi: 10.1097/MCP.0b013e32833642f2
[24] McFarland C, Willson D, Sloan J, Coultas D . A randomized trial comparing 2 types of in-home rehabilitation for chronic obstructive pulmonary disease: a pilot study[J]. J Geriatr Phys Ther, 2012,35(3):132-139
doi: 10.1519/JPT.0b013e31824145f5
[25] Bourbeau J . Making pulmonary rehabilitation a success in COPD[J]. Swiss Med Wkly, 2010,140:w13067
[26] Moore L, Hogg L, White P . Acceptability and feasibility of pulmonary rehabilitation for COPD: a community qualitative study[J]. Prim Care Respir J, 2012,21(4):419-424
doi: 10.4104/pcrj.2012.00086
[27] Egan C, Deering BM, Blake C, Fullen BM , McCormack NM, Spruit MA, Costello RW.Short term and long term effects of pulmonary rehabilitation on physical activity in COPD[J]. Respir Med, 2012,106(12):1671-1679
doi: 10.1016/j.rmed.2012.08.016
[28] Vorrink SN, Kort HS, Troosters T, Lammers JW . Level of daily physical activity in individuals with COPD compared with healthy controls[J]. Respir Res, 2011,12:33
doi: 10.1186/1465-9921-12-33
[29] Xu YH, Wang JH, Li HF, Zhu XH, Wang G . Efficacy of integrative respiratory rehabilitation training in exercise ability and quality of life of patients with chronic obstructive pulmonary disease in stable phase: a randomized controlled trial[J]. J Chin Integr Med, 2010,8(5):432-437
doi: 10.3736/jcim
[1] Sherman Gu, Arthur Yin Fan. Controversial conclusions from two randomized controlled trials for acupuncture's effects on polycystic ovary syndrome or in vitro fertilization support. Journal of Integrative Medicine, 2020, 18(2): 89-91.
[2] Gerli E.G. Herr, Fábio Goulart da Silva, Francisco José Cidral-Filho, Fabricia Petronilho, Lucinéia Gainski Danielski, Mariana Pereira de Souza Goldim, Afonso Shiguemi Inoue Salgado, Franciane Bobinski, Daniel Fernandes Martins, Eliane R. Winkelmann. Effects of the use of bioceramic wraps in patients with lower limb venous ulcers: A randomized double-blind placebo-controlled trial. Journal of Integrative Medicine, 2020, 18(1): 27-.
[3] Xin-yu Yue, Zhuo-qi Feng, Xi-yi Yu, Jia-min Hu, Xiao-Jing He, Shi Shu. Fire-needle acupuncture for upper limb spastic paralysis after stroke: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 167-172.
[4] Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei, Liu, Hui Zheng, You-ping Hu. Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial. Journal of Integrative Medicine, 2019, 17(3): 161-167.
[5] Pádraic J.Dunne, Julie Lynch, Lucia Prihodova, Caoimhe O'Leary, Atiyeh Ghoreyshi, Sharee A. Basdeo, Donal J.Cox, Rachel Breen, Ali Sheikhi, Áine Carroll, Cathal Walsh, Geraldine McMahon, Barry White. Burnout in the emergency department: Randomized controlled trial of an attention-based training program. Journal of Integrative Medicine, 2019, 17(3): 173-180.
[6] Arthur Yin Fan, Sarah F. Alemi, Yingping H. Zhu, Sudaba Rahimi, Hui Wei, Haihe Tian, Deguang He, Changzhen Gong, Guanhu Yang, Chong He, Hui Ouyang . Effectiveness of two different acupuncture strategies in patients with vulvodynia: Study protocol for a pilot pragmatic controlled trial. Journal of Integrative Medicine, 2018, 16(6): 384-389.
[7] Xin-fang Zhang, Shui-ying Xiang, Wen-ye Geng, Wen-juan Cong, Jing Lu, Chuan-wei Jiang, Kun Wang, Zi-bing Liu . Electro-acupuncture regulates the cholinergic anti-inflammatory pathway in a rat model of chronic obstructive pulmonary disease. Journal of Integrative Medicine, 2018, 16(6): 418-426.
[8] J.M. Oliver-Baxter, H.S. Whitford, D.A. Turnbull, M.J. Bond. Effects of vitamin supplementation on inflammatory markers and psychological wellbeing among distressed women: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(5): 322-328.
[9] Parunkul Tungsukruthai, Preecha Nootim, Wiwan Worakunphanich, Nareerat Tabtong. Efficacy and safety of herbal steam bath in allergic rhinitis: A randomized controlled trial. Journal of Integrative Medicine, 2018, 16(1): 39-44.
[10] Zahra Hajmohammadi, Mojtaba Heydari, Majid Nimrouzi, Pouya Faridi, Mohammad Javad Zibaeenezhad, Gholamhossein Ranjbar Omrani, Mesbah Shams . Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: A double-blind placebo-controlled randomized clinical trial. Journal of Integrative Medicine, 2018, 16(1): 45-50.
[11] Laura Belland, Laura Rivera-Reyes, Ula Hwang. Using music to reduce anxiety among older adults in the emergency department: A randomized pilot study. Journal of Integrative Medicine, 2017, 15(6): 450-455.
[12] Hilal Yuksel, Yasemin Cayir, Zahide Kosan, Kenan Tastan. Effectiveness of breathing exercises during the second stage of labor on labor pain and duration: A randomized controlled trial. Journal of Integrative Medicine, 2017, 15(6): 456-461.
[13] Yoshiharu Motoo, Takashi Hakamatsuka, Nobuo Kawahara, Ichiro Arai, Kiichiro Tsutani. Standards of Reporting Kampo Products (STORK) in research articles. Journal of Integrative Medicine, 2017, 15(3): 182-185.
[14] Susana Seca, Sebastian Kirch, António S.Cabrita, Henry J.Greten. Evaluation of the effect of acupuncture on hand pain, functional deficits and health-related quality of life in patients with rheumatoid arthritis—A study protocol for a multicenter, double-blind, randomized clinical trial. Journal of Integrative Medicine, 2016, 14(3): 219-227.
[15] Maria T.Chao, AlexandraChang, SanjayReddy, James D.Harrison, JosephAcquah, MiriaToveg, TrilceSantana, Frederick M.Hecht. Adjunctive acupuncture for pain and symptom management in the inpatient setting: Protocol for a pilot hybrid effectiveness-implementation study. Journal of Integrative Medicine, 2016, 14(3): 228-238.
Viewed
Full text


Abstract

Cited

  Shared   
  Discussed   
[1] Jun Cai, Hua Wang, Sheng Zhou, Bin Wu, Hua-rong Song, Zheng-rong Xuan. Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: A randomized controlled trial. Journal of Chinese Integrative Medicine, 2008, 6(1): 37-40
[2] Min Cheng, Qiong Feng, Shu-wen Qian, Hui Gao, Cui-qing Zhu. Preliminary assay of p-amyloid binding elements in heart-beneficial recipe. Journal of Chinese Integrative Medicine, 2008, 6(1): 68-72
[3] Hai-feng Wei, Bai-liu Ya, Ling Zhao, Cui-fei Ye, Li Zhang, Lin Li. Evaluation of tongue manifestation of blood stasis syndrome and its relationship with blood rheological disorder in a rat model of transient brain ischemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 73-76
[4] A-gao Zhou, Yong Zhang, Gang Kui, De-Yun Kong, Hai-liang Ge, Qiu-hua Ren, Jia-rong Dong, Sheng Hong, Xu-ming Mao, Yin Wang, Hui-zheng Zhang, Shu-jun Wang. Influence of traditional Chinese compound recipes with different efficacy on body weight, tumor weight and immune function in H22 cancer-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 77-82
[5] Guo-hong Yuan, Xiao-jing Pang, He-chao Ma. Synergic effects of Danggui Buxue Decoction in reducing toxicity of cytoxan in tumor-bearing mice. Journal of Chinese Integrative Medicine, 2008, 6(1): 83-88
[6] Li Zhou, Hong-xing Zhang, Ling-guang Liu, Wen-jun Wan. Effect of electro-acupuncture at Fenglong (GV 16) on nitric oxide and endothelin in rats with hyperlipidemia. Journal of Chinese Integrative Medicine, 2008, 6(1): 89-92
[7] Jin-zhou Tian, Jing Shi, Xin-qing Zhang, Qi Bi, Xin Ma, Zhi-liang Wang, Xiao-bin Li, Shu-li Shen, Lin Li, Zhen-yun Wu, Li-yan Fang, Xiao-dong Zhao, Ying-chun Miao, Peng-wen Wang, Ying Ren, Jun-xiang Yin, Yong-yan Wang, Beijing United Study Group on MCI of the Capital Foundation of Medical Developments. Guiding principles of clinical research on mild cognitive impairment (protocol). Journal of Chinese Integrative Medicine, 2008, 6(1): 9-14
[8] Daniel Weber, Janelle M Wheat, Geoffrey M Currie. Inflammation and cancer: Tumor initiation, progression and metastasis,and Chinese botanical medicines. Journal of Chinese Integrative Medicine, 2010, 8(11): 1006-1013
[9] Bo Wang , Wei Yan , Li-hui Hou, Xiao-ke Wu. Disorder of Tiangui (kidney essence) and reproductive dysfunction in patients with polycystic ovary syndrome. Journal of Chinese Integrative Medicine, 2010, 8(11): 1018-1022
[10] Yan-bo Zhu , Qi Wang, Cheng-yu Wu, Guo-ming Pang, Jian-xiong Zhao, Shi-lin Shen, Zhong-yuan Xia , Xue Yan . Logistic regression analysis on relationships between traditional Chinese medicine constitutional types and overweight or obesity. Journal of Chinese Integrative Medicine, 2010, 8(11): 1023-1035