A comparison of new cardiovascular endurance test using the 2-minute marching test vs. 6-minute walk test in healthy volunteers: A crossover randomized controlled trial

This was a 2×2 randomized crossover control trial to compare the cardiovascular endurance of healthy volunteers using a 2-minute marching test (2MMT) and a 6-minute walk test (6MWT). This study included 254 participants of both sexes, aged 20–50 years, with a height and body mass index (BMI) of ≥150 cm and ≤25 kg/m2, respectively. Participants could perform activities independently and had normal annual chest radiographs and electrocardiograms. A group-randomized design was used to assign participants to Sequence 1 (AB) or 2 (BA). The tests were conducted over 2 consecutive days, with a 1-day washout period. On day 1, the participants randomly underwent either a 6MWT or 2MMT in a single-anonymized setup, and on day 2, the tests were performed in reverse order. We analyzed maximal oxygen consumption (VO2max) as the primary outcome and heart rate (HR), respiratory rate (RR), blood pressure (BP), oxygen saturation, dyspnea, and leg fatigue as secondary outcomes. Data were collected from 12..., Sample size
The sample size required for the equivalence study was estimated using nQuery software and calculated using two one-sided equivalence tests for crossover design. To calculate the sample size, we set the alpha error probability, statistical power, the lower equivalence limit, and upper equivalence limit at 5%, 90%, -2.00, and +2.00, respectively, using the clinical margin (minimal clinically important difference [MCID] of VO2max from a previous study, which was 2 ml/kg/min [15], and standard deviation was 8.6 [16]. Based on these values, we needed 101 participants for the crossover design, allowing for a 20% dropout rate. Therefore, we decided to randomize 127 patients per arm, resulting in 254 participants. However, due to the COVID-19 pandemic, data collection was incomplete, and we could only analyze 127 data sets in this study.
Inclusion and exclusion criteria
The inclusion criteria were male and female healthy volunteers, aged 20–50 years, with height: ≥150 cm and, BMI ≤..., , # A comparison of new cardiovascular endurance test using the 2-minute marching test vs. 6-minute walk test in healthy volunteers: A crossover randomized controlled trial

[https://doi.org/10.5061/dryad.31zcrjdv2](https://doi.org/10.5061/dryad.31zcrjdv2)

We have submitted data tables 1-3 for the description of (Fig 1 CONSORT diagram of the study_figure.TIFF), (Fig 2 The trial design_figure.TIFF, and(Fig 3 The study protocol_figure.TIFF), and submitted of data analysis (Table 1 Baseline characteristics_data.CVS),(Table 2 Equivalence test of VO2max between 2MMT and 6MWT_data.CVS), (Table 3 Mean and standard deviation of 6MWT and 2MMT_data.CVS), and (Table 4 Comparison of secondary outcomes between 6MWT and 2MMT_data.CVS)

## Description

### **Fig 1 CONSORT diagram of the study**\Figure

#### Materials and Methods

The trial protocol and supporting Consolidated Standards of Reporting Trials (CONSORT) checklist are available as supporting information (S1 File CONSORT Checklist) and the CO...

本研究为一项2×2交叉随机对照试验，旨在对比健康志愿者接受2分钟行军试验（2-minute marching test, 2MMT）与6分钟步行试验（6-minute walk test, 6MWT）后的心血管耐力水平。本研究共纳入254名男女受试者，年龄介于20~50岁，身高≥150 cm，体重指数（body mass index, BMI）≤25 kg/m²。受试者可独立完成日常活动，年度胸部X线片与心电图检查结果均正常。研究采用整群随机分组设计，将受试者分配至序列1（AB）或序列2（BA）。测试于连续2天内完成，期间设置1天的洗脱期。第1天时，受试者在单盲设置下随机接受6MWT或2MMT；第2天则采用相反顺序完成两项测试。本研究以最大摄氧量（maximal oxygen consumption, VO2max）作为主要结局指标，以心率（heart rate, HR）、呼吸频率（respiratory rate, RR）、血压（blood pressure, BP）、血氧饱和度、呼吸困难程度及下肢疲劳度作为次要结局指标。数据收集自12..., 样本量
本等效性研究所需的样本量通过nQuery软件估算，采用针对交叉设计的双侧单侧等效检验进行计算。样本量计算时，我们参考既往研究中最大摄氧量的最小临床重要差异（minimal clinically important difference, MCID）为2 ml/kg/min[15]，标准差为8.6[16]，将α错误概率、统计效力、等效下限与等效上限分别设置为5%、90%、-2.00及+2.00。基于上述参数，交叉设计所需的样本量为101例，考虑20%的脱落率后，最终计划每组随机纳入127例受试者，总样本量为254例。但受新型冠状病毒肺炎（COVID-19）疫情影响，数据收集未完成，本研究最终仅完成127份数据集的分析。

纳入与排除标准
纳入标准为年龄20~50岁、身高≥150 cm、BMI≤..., 的男女健康志愿者。

# 健康志愿者中2分钟行军试验与6分钟步行试验的新型心血管耐力测试对比：一项交叉随机对照试验

[https://doi.org/10.5061/dryad.31zcrjdv2](https://doi.org/10.5061/dryad.31zcrjdv2)

本研究已提交如下资料：研究相关图表（图1 研究CONSORT流程图_figure.TIFF、图2 试验设计图_figure.TIFF及图3 研究方案图_figure.TIFF），以及数据分析表格（表1 基线特征_data.CVS、表2 2MMT与6MWT间VO2max的等效性检验_data.CVS、表3 6MWT与2MMT的均值及标准差_data.CVS、表4 6MWT与2MMT的次要结局指标对比_data.CVS）

## 说明
### **图1 研究CONSORT流程图**图表

#### 材料与方法
试验方案及配套的报告试验综合标准（Consolidated Standards of Reporting Trials, CONSORT）清单可在补充材料（S1文件 CONSORT清单）及CO...中获取