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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Hong Pan, Yingxia Pei, Bingxue Li, Yi Wang, Jie Liu, Hongsheng Lin
Wichtige Hinweise

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.

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.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 128 kb)
13063_2017_2320_MOESM1_ESM.doc
Additional file 2: Informed Consent form - Informed notice page (Chinese version). (DOC 44 kb)
13063_2017_2320_MOESM2_ESM.doc
Literatur
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