中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600127128
最近更新日期： Date of Last Refreshed on：	2026-06-25 11:09:52
注册时间： Date of Registration：	2026-06-25 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	Effects of Wearing a Sauna Suit During High-Intensity Interval Exercise
Public title：	Effects of Wearing a Sauna Suit During High-Intensity Interval Exercise
注册题目简写：
English Acronym：
研究课题的正式科学名称：	The Acute Effects of HIIT While Wearing Sauna Suits on Physiological and Perceptual Responses
Scientific title：	The Acute Effects of HIIT While Wearing Sauna Suits on Physiological and Perceptual Responses
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	Wei Likun	研究负责人：	Wei Likun
Applicant：	Wei Likun	Study leader：	Wei Likun
申请注册联系人电话： Applicant telephone：	+86 180 8190 7006	研究负责人电话： Study leader's telephone：	+86 180 8190 7006
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	weilikun_scu@163.com	研究负责人电子邮件： Study leader's E-mail：	weilikun_scu@163.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong	研究负责人通讯地址：	The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
Applicant address：	The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong	Study leader's address：	The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：
Applicant's institution：	The Chinese University of Hong Kong
研究负责人所在单位：
Affiliation of the Leader：	The Chinese University of Hong Kong

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	EDU2025-102	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	Survey and Behavioral Research Ethics Committee of the Chinese University of Hong Kong
Name of the ethic committee：	Survey and Behavioral Research Ethics Committee of the Chinese University of Hong Kong
伦理委员会批准日期： Date of approved by ethic committee：	2025-04-09 00:00:00
伦理委员会联系人：	Survey and Behavioral Research Ethics Committee of the Chinese University of Hong Kong
Contact Name of the ethic committee：	Survey and Behavioral Research Ethics Committee of the Chinese University of Hong Kong
伦理委员会联系地址：	The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
Contact Address of the ethic committee：	The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 180 8190 7006	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

Primary sponsor's address：

The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	China	省(直辖市)：	Hong Kong	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	The Chinese University of Hong Kong	具体地址：	The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong
Institution hospital：	The Chinese University of Hong Kong	Address：	The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong

经费或物资来源：

University Research Funding

Source(s) of funding：

University Research Funding

研究疾病：

No

Target disease：

No

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

This study aims to investigate the acute physiological and perceptual consequences of performing high-intensity interval training (HIIT) while wearing sauna suits, with a specific focus on three critical outcomes: (1) the impact on core body temperature, skin temperature, (2) the impact on perceptual responses such as thermal sensation, RPE (3) the influence on energy expenditure and metabolic rate.

Objectives of Study：

This study aims to investigate the acute physiological and perceptual consequences of performing high-intensity interval training (HIIT) while wearing sauna suits, with a specific focus on three critical outcomes: (1) the impact on core body temperature, skin temperature, (2) the impact on perceptual responses such as thermal sensation, RPE (3) the influence on energy expenditure and metabolic rate.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

Exclusion from participation included current or recent (< 6 months) smokers, and those with any past or present history of cardiovascular diseases and/or heat-related contraindications.

Exclusion criteria：

Exclusion from participation included current or recent (< 6 months) smokers, and those with any past or present history of cardiovascular diseases and/or heat-related contraindications.

研究实施时间：

Study execute time：

从 From 2025-02-01 00:00:00至 To 2025-04-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-02-10 00:00:00 至 To 2025-02-28 00:00:00

干预措施：

Interventions：

组别：	Sauna suit first, then control condition	样本量：	12
Group：	Sauna suit first, then control condition	Sample size：	12
干预措施：	First trial: Perform high-intensity interval exercise (HIIE) wearing a commercially available whole-body vinyl sauna suit (CORE Heat Training Suit, Core, Swiss) under controlled environmental conditions (20℃–22℃, 30–36% humidity); the HIIE protocol was 3-min warm-up at 80W + 8×(1-min cycling at 80% peak power output [PPO] interspersed with 1-min active recovery at 25% PPO) + 3-min cool-down at 40W (sauna suit worn during the entire exercise process). Second trial (≥3 days after the first): Perform the same HIIE protocol and environmental conditions without wearing the sauna suit (normal clothing only).	干预措施代码：
Intervention：	First trial: Perform high-intensity interval exercise (HIIE) wearing a commercially available whole-body vinyl sauna suit (CORE Heat Training Suit, Core, Swiss) under controlled environmental conditions (20℃–22℃, 30–36% humidity); the HIIE protocol was 3-min warm-up at 80W + 8×(1-min cycling at 80% peak power output [PPO] interspersed with 1-min active recovery at 25% PPO) + 3-min cool-down at 40W (sauna suit worn during the entire exercise process). Second trial (≥3 days after the first): Perform the same HIIE protocol and environmental conditions without wearing the sauna suit (normal clothing only).	Intervention code：

组别：	Control condition first, then sauna suit	样本量：	12
Group：	Control condition first, then sauna suit	Sample size：	12
干预措施：	First trial: Perform the same HIIE protocol under controlled environmental conditions (20℃–22℃, 30–36% humidity) with normal clothing only (no sauna suit). Second trial (≥3 days after the first): Perform the same HIIE protocol and environmental conditions while wearing a commercially available whole-body vinyl sauna suit (CORE Heat Training Suit, Core, Swiss) (worn during the entire exercise process).	干预措施代码：
Intervention：	First trial: Perform the same HIIE protocol under controlled environmental conditions (20℃–22℃, 30–36% humidity) with normal clothing only (no sauna suit). Second trial (≥3 days after the first): Perform the same HIIE protocol and environmental conditions while wearing a commercially available whole-body vinyl sauna suit (CORE Heat Training Suit, Core, Swiss) (worn during the entire exercise process).	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	China	省(直辖市)：	Hong Kong	市(区县)：
Country：	China	Province：	Hong Kong	City：
单位(医院)：	The Chinese University of Hong Kong	单位级别：	University
Institution hospital：	The Chinese University of Hong Kong	Level of the institution：	University

测量指标：

Outcomes：

指标中文名：	Skin temperature	指标类型：	主要指标
Outcome：	Skin temperature	Type：	Primary indicator
测量时间点：	Continuously recorded throughout the entire trial (warm-up, HIIE, cool-down); additionally, assessed at the end of each exercise interval	测量方法：
Measure time point of outcome：	Continuously recorded throughout the entire trial (warm-up, HIIE, cool-down); additionally, assessed at the end of each exercise interval	Measure method：

指标中文名：	Core temperature	指标类型：	主要指标
Outcome：	Core temperature	Type：	Primary indicator
测量时间点：	Continuously recorded throughout the entire trial (warm-up, HIIE, cool-down); additionally, assessed at the end of each exercise interval	测量方法：
Measure time point of outcome：	Continuously recorded throughout the entire trial (warm-up, HIIE, cool-down); additionally, assessed at the end of each exercise interval	Measure method：

指标中文名：	Core-to-skin thermal gradient	指标类型：	主要指标
Outcome：	Core-to-skin thermal gradient	Type：	Primary indicator
测量时间点：	Calculated and derived from continuous Tc/Tsk data throughout the trial; assessed at the end of each exercise interval	测量方法：
Measure time point of outcome：	Calculated and derived from continuous Tc/Tsk data throughout the trial; assessed at the end of each exercise interval	Measure method：

指标中文名：	Sweat loss	指标类型：	主要指标
Outcome：	Sweat loss	Type：	Primary indicator
测量时间点：	Calculated from pre-exercise and post-exercise towel-dried body mass measurements (primary); sweat rate estimated for the entire exercise duration	测量方法：
Measure time point of outcome：	Calculated from pre-exercise and post-exercise towel-dried body mass measurements (primary); sweat rate estimated for the entire exercise duration	Measure method：

指标中文名：	Heart rate	指标类型：	主要指标
Outcome：	Heart rate	Type：	Primary indicator
测量时间点：	Continuously recorded throughout the entire trial; recorded at the end of each HIIE interval	测量方法：
Measure time point of outcome：	Continuously recorded throughout the entire trial; recorded at the end of each HIIE interval	Measure method：

指标中文名：	Blood lactate level	指标类型：	主要指标
Outcome：	Blood lactate level	Type：	Primary indicator
测量时间点：	Resting level (before exercise, finger prick sampling); recorded at the end of each HIIE interval	测量方法：
Measure time point of outcome：	Resting level (before exercise, finger prick sampling); recorded at the end of each HIIE interval	Measure method：

指标中文名：	Energy expenditure	指标类型：	主要指标
Outcome：	Energy expenditure	Type：	Primary indicator
测量时间点：	Continuously recorded throughout the entire trial (via breath-by-breath gas exchange data, collected every 30 seconds)	测量方法：
Measure time point of outcome：	Continuously recorded throughout the entire trial (via breath-by-breath gas exchange data, collected every 30 seconds)	Measure method：

指标中文名：	Urine specific gravity	指标类型：	主要指标
Outcome：	Urine specific gravity	Type：	Primary indicator
测量时间点：	Pre-exercise (to assess hydration status; repeated 30 mins later if initial USG ≥1.020 g/ml)	测量方法：
Measure time point of outcome：	Pre-exercise (to assess hydration status; repeated 30 mins later if initial USG ≥1.020 g/ml)	Measure method：

指标中文名：	Body mass	指标类型：	主要指标
Outcome：	Body mass	Type：	Primary indicator
测量时间点：	Pre-exercise (towel-dried, underwear only) and post-exercise (towel-dried) for each trial; measured at every laboratory visit	测量方法：
Measure time point of outcome：	Pre-exercise (towel-dried, underwear only) and post-exercise (towel-dried) for each trial; measured at every laboratory visit	Measure method：

指标中文名：	Peak power output	指标类型：	主要指标
Outcome：	Peak power output	Type：	Primary indicator
测量时间点：	Assessed during the incremental exercise test (baseline, ≥48h before the first experimental session)	测量方法：
Measure time point of outcome：	Assessed during the incremental exercise test (baseline, ≥48h before the first experimental session)	Measure method：

指标中文名：	Maximal oxygen uptake	指标类型：	主要指标
Outcome：	Maximal oxygen uptake	Type：	Primary indicator
测量时间点：	Assessed during the incremental exercise test (baseline, ≥48h before the first experimental session)	测量方法：
Measure time point of outcome：	Assessed during the incremental exercise test (baseline, ≥48h before the first experimental session)	Measure method：

指标中文名：	Rating of perceived exertion	指标类型：	主要指标
Outcome：	Rating of perceived exertion	Type：	Primary indicator
测量时间点：	Recorded at the end of each HIIE interval	测量方法：
Measure time point of outcome：	Recorded at the end of each HIIE interval	Measure method：

指标中文名：	Thermal sensation	指标类型：	主要指标
Outcome：	Thermal sensation	Type：	Primary indicator
测量时间点：	Rated at the end of each HIIE interval (scale: -4 [unbearably cold] to +4 [unbearably hot])	测量方法：
Measure time point of outcome：	Rated at the end of each HIIE interval (scale: -4 [unbearably cold] to +4 [unbearably hot])	Measure method：

指标中文名：	Thermal comfort	指标类型：	主要指标
Outcome：	Thermal comfort	Type：	Primary indicator
测量时间点：	Assessed at the end of each HIIE interval (scale: +4 [comfortable] to -4 [very uncomfortable])	测量方法：
Measure time point of outcome：	Assessed at the end of each HIIE interval (scale: +4 [comfortable] to -4 [very uncomfortable])	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：		组织：
Sample Name：	Finger prick whole blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	Urine	组织：
Sample Name：	Urine	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	24	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Permuted block randomization (block size = 4) was used for random sequence generation, and the random number sequence was produced by an independent researcher who was not involved in participant recruitment, data collection or experimental interventions. Allocation concealment was achieved via sequentially numbered, opaque, sealed envelopes (SNOSE).

Randomization Procedure (please state who generates the random number sequence and by what method)：

Permuted block randomization (block size = 4) was used for random sequence generation, and the random number sequence was produced by an independent researcher who was not involved in participant recruitment, data collection or experimental interventions. Allocation concealment was achieved via sequentially numbered, opaque, sealed envelopes (SNOSE).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	None
Blinding：	None
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	Within six months after the paper is published,National Population Health Science Data Center, https://www.ncmi.cn/index.html
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Within six months after the paper is published,National Population Health Science Data Center, https://www.ncmi.cn/index.html
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	This study applies standard data collection and management system. We adopt unified case report form (CRF) for data recording, and use professional electronic data capture (EDC) system to complete data entry, verification, quality control and data locking, ensuring standardized and standardized management of all trial data.
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	This study applies standard data collection and management system. We adopt unified case report form (CRF) for data recording, and use professional electronic data capture (EDC) system to complete data entry, verification, quality control and data locking, ensuring standardized and standardized management of all trial data.
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2026-06-25 11:07:40