Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial
Abstract Background Impairment of exercise capacity remains a common adverse effect of non-small cell lung cancer (NSCLC) survivors after surgery. Previous research has suggested that Tai Chi Chuan (TCC) offers an exercise capacity benefit in several types of cancers. This is a randomized trial to i...
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| Format: | Article |
| Language: | English |
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BMC
2018-01-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-017-2320-x |
| _version_ | 1818009276249014272 |
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| author | Hong Pan Yingxia Pei Bingxue Li Yi Wang Jie Liu Hongsheng Lin |
| author_facet | Hong Pan Yingxia Pei Bingxue Li Yi Wang Jie Liu Hongsheng Lin |
| author_sort | Hong Pan |
| collection | DOAJ |
| description | Abstract Background Impairment of exercise capacity remains a common adverse effect of non-small cell lung cancer (NSCLC) survivors after surgery. Previous research has suggested that Tai Chi Chuan (TCC) offers an exercise capacity benefit in several types of cancers. This is a randomized trial to investigate the efficacy and safety of TCC in postoperative NSCLC patients over an observation period of 3 months and a 9-month follow-up. Methods/design Using a prospective, one center and randomized design, 120 subjects with histologically confirmed stage I–IIIA NSCLC following complete surgical resection will potentially be eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of two conditions: (1) TCC training, or (2) placebo control. The training sessions for both groups will last 60 min and take place three times a week for 3 months. The sessions will be supervised with target intensity of 60–80% of work capacity, dyspnea, and heart rate management. The primary study endpoint is peak oxygen consumption (VO2peak), and the secondary endpoints include: 6-min walk distance (6MWD), health-related quality of life (HRQoL), lung function, immunity function, and the state of depression and anxiety. All endpoints will be assessed at the baseline and postintervention (3 months). A follow-up period of 9 months will be included. The main time points for the evaluation of clinical efficacy and safety will be months 3, 6, 9, and 12 after enrollment. Discussion This study will assess the effect of group TCC in postsurgery NSCLC survivors on VO2peak, lung function, and other aspects. The results of this study will eventually provide clinical proof of the application of TCC as one kind of exercise training for patients across the entire NSCLC continuum, as well as information on the safety and feasibility of exercise. Trial Registration Chinese Clinical Trial Registry: ChiCTR-IOR-15006548 . Registered on 12 June 2015. |
| first_indexed | 2024-04-14T05:39:58Z |
| format | Article |
| id | doaj.art-2087fde1fd1b4ce28d08d29670e9abf7 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-14T05:39:58Z |
| publishDate | 2018-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-2087fde1fd1b4ce28d08d29670e9abf72022-12-22T02:09:28ZengBMCTrials1745-62152018-01-011911910.1186/s13063-017-2320-xTai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trialHong Pan0Yingxia Pei1Bingxue Li2Yi Wang3Jie Liu4Hongsheng Lin5Department of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesDepartment of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesDepartment of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesDepartment of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesDepartment of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesDepartment of Oncology, Guang’anmen Hospital, China Academy of Chinese Medical SciencesAbstract Background Impairment of exercise capacity remains a common adverse effect of non-small cell lung cancer (NSCLC) survivors after surgery. Previous research has suggested that Tai Chi Chuan (TCC) offers an exercise capacity benefit in several types of cancers. This is a randomized trial to investigate the efficacy and safety of TCC in postoperative NSCLC patients over an observation period of 3 months and a 9-month follow-up. Methods/design Using a prospective, one center and randomized design, 120 subjects with histologically confirmed stage I–IIIA NSCLC following complete surgical resection will potentially be eligible for this trial. Following baseline assessments, eligible participants will be randomly assigned to one of two conditions: (1) TCC training, or (2) placebo control. The training sessions for both groups will last 60 min and take place three times a week for 3 months. The sessions will be supervised with target intensity of 60–80% of work capacity, dyspnea, and heart rate management. The primary study endpoint is peak oxygen consumption (VO2peak), and the secondary endpoints include: 6-min walk distance (6MWD), health-related quality of life (HRQoL), lung function, immunity function, and the state of depression and anxiety. All endpoints will be assessed at the baseline and postintervention (3 months). A follow-up period of 9 months will be included. The main time points for the evaluation of clinical efficacy and safety will be months 3, 6, 9, and 12 after enrollment. Discussion This study will assess the effect of group TCC in postsurgery NSCLC survivors on VO2peak, lung function, and other aspects. The results of this study will eventually provide clinical proof of the application of TCC as one kind of exercise training for patients across the entire NSCLC continuum, as well as information on the safety and feasibility of exercise. Trial Registration Chinese Clinical Trial Registry: ChiCTR-IOR-15006548 . Registered on 12 June 2015.http://link.springer.com/article/10.1186/s13063-017-2320-xTai Chi ChuanExercise capacityNon-small cell lung cancerPostoperation |
| spellingShingle | Hong Pan Yingxia Pei Bingxue Li Yi Wang Jie Liu Hongsheng Lin Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial Trials Tai Chi Chuan Exercise capacity Non-small cell lung cancer Postoperation |
| title | Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial |
| title_full | Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial |
| title_fullStr | Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial |
| title_full_unstemmed | Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial |
| title_short | Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial |
| title_sort | tai chi chuan in postsurgical non small cell lung cancer patients study protocol for a randomized controlled trial |
| topic | Tai Chi Chuan Exercise capacity Non-small cell lung cancer Postoperation |
| url | http://link.springer.com/article/10.1186/s13063-017-2320-x |
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