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Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial

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 investiga...

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Autores principales: Pan, Hong, Pei, Yingxia, Li, Bingxue, Wang, Yi, Liu, Jie, Lin, Hongsheng
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5753515/
https://www.ncbi.nlm.nih.gov/pubmed/29301544
http://dx.doi.org/10.1186/s13063-017-2320-x
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author Pan, Hong
Pei, Yingxia
Li, Bingxue
Wang, Yi
Liu, Jie
Lin, Hongsheng
author_facet Pan, Hong
Pei, Yingxia
Li, Bingxue
Wang, Yi
Liu, Jie
Lin, Hongsheng
author_sort Pan, Hong
collection PubMed
description 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 (VO(2peak)), 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 VO(2peak), 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2320-x) contains supplementary material, which is available to authorized users.
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spelling pubmed-57535152018-01-05 Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial Pan, Hong Pei, Yingxia Li, Bingxue Wang, Yi Liu, Jie Lin, Hongsheng Trials Study Protocol 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 (VO(2peak)), 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 VO(2peak), 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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13063-017-2320-x) contains supplementary material, which is available to authorized users. BioMed Central 2018-01-04 /pmc/articles/PMC5753515/ /pubmed/29301544 http://dx.doi.org/10.1186/s13063-017-2320-x Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Pan, Hong
Pei, Yingxia
Li, Bingxue
Wang, Yi
Liu, Jie
Lin, Hongsheng
Tai Chi Chuan in postsurgical non-small cell lung cancer patients: study protocol for a randomized controlled trial
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 Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5753515/
https://www.ncbi.nlm.nih.gov/pubmed/29301544
http://dx.doi.org/10.1186/s13063-017-2320-x
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