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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2500113733 |
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最近更新日期: Date of Last Refreshed on: |
2025-12-02 15:37:13 |
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注册时间: Date of Registration: |
2025-12-02 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
下肢血流限制间歇训练对速度滑冰运动员急性反应和训练适应的影响 |
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Public title: |
Effects of Lower Limb Blood Flow Restriction Interval Training on Acute Responses and Training Adaptations in Speed Skaters |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
下肢血流限制间歇训练对速度滑冰运动员急性反应和训练适应的影响 |
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Scientific title: |
Effects of Lower Limb Blood Flow Restriction Interval Training on Acute Responses and Training Adaptations in Speed Skaters |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
张凯 |
研究负责人: |
李有强 |
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Applicant: |
Kai Zhang |
Study leader: |
Youqiang Li |
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申请注册联系人电话: Applicant telephone: |
+86 138 0543 7076 |
研究负责人电话: Study leader's telephone: |
+86 138 1618 4635 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
80220854@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
youmecity@163.com |
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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): |
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申请注册联系人通讯地址: |
上海市杨浦区长海路399号 |
研究负责人通讯地址: |
上海市杨浦区长海路399号 |
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Applicant address: |
399 Changhai Road, Yangpu District, Shanghai, China |
Study leader's address: |
399 Changhai Road, Yangpu District, Shanghai, China |
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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: |
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申请人所在单位: |
上海体育大学 |
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Applicant's institution: |
Shanghai University of Sport |
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研究负责人所在单位: |
上海体育大学 |
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Affiliation of the Leader: |
Shanghai University of Sport |
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是否获伦理委员会批准: |
是/Yes |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
102772024RT024 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
上海体育大学科学研究伦理委员会 |
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Name of the ethic committee: |
Scientific Research Ethics Committee, Shanghai University of Sport |
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伦理委员会批准日期: Date of approved by ethic committee: |
2024-05-22 00:00:00 |
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伦理委员会联系人: |
程蓉 |
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Contact Name of the ethic committee: |
rong cheng |
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伦理委员会联系地址: |
上海市杨浦区长海路399号 |
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Contact Address of the ethic committee: |
399 Changhai Road, Yangpu District, Shanghai, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 21 6550 8179 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
上海体育大学 |
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Primary sponsor: |
Shanghai University of Sport |
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研究实施负责(组长)单位地址: |
上海市杨浦区长海路399号 |
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Primary sponsor's address: |
399 Changhai Road, Yangpu District, Shanghai, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
无 |
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Source(s) of funding: |
None |
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Target disease: |
None |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
系统评估基于仿真滑冰垫(滑行板)的训练方案与下肢血流限制(BFR)结合间歇训练对速度滑冰运动员的急性反应与长期训练适应及竞技表现的影响,形成安全、有效、可复制的专项训练方案。 1. 基于仿真滑冰垫(滑行板)的 HIIT 方案设计、验证与优化: (1)依据 HIIT 原则设计并与传统/持续有氧方案比较; (2)验证对心肺功能、有氧/无氧能力、肌肉耐力等训练效果; (3)在验证基础上优化参数,提供可行且符合专项特征的处方。 2.下肢 BFR 结合间歇训练的急性生理与知觉反应: 在子研究 1 优化的滑行板间歇框架上,降低运动强度并加入/不加入 BFR,比较心率、血压、血乳酸等生理指标及主观用力感、身体不适等知觉反应;并与不加 BFR 的同等强度间歇/HIIT 条件比较,评估安全性与即时效应。 3. 8 周下肢 BFR 结合间歇训练的训练适应与竞技表现: 比较 8 周有/无 BFR 的低强度间歇滑行板训练对 VO?max、无氧能力、肌肉适应(力量/耐力)及计时表现的影响,并与 HIIT 的长期效应比较,评估其在专项长期应用中的适应性与潜在训练收益。 |
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Objectives of Study: |
Overall Objective To comprehensively evaluate, the effects of slide-board–based interval training and lower-limb blood-flow-restriction (BFR) interval training on acute responses, long-term training adaptations, and performance in speed skaters, and to establish safe, effective, and reproducible sport-specific training prescriptions. 1. Design, validation, and optimization of a slide-board HIIT protocol (1) Develop a slide-board HIIT protocol according to HIIT principles and compare it with traditional/continuous aerobic protocols; (2) Verify its effects on cardiorespiratory fitness, aerobic/anaerobic capacity, and muscular endurance; (3) Optimize key parameters to generate a feasible, sport-specific prescription. 2. Acute physiological and perceptual responses to lower-limb BFR interval training Within the interval framework optimized, reduce exercise intensity and compare with vs. without BFR conditions on heart rate, blood pressure, blood lactate, ratings of perceived exertion, and symptoms/discomfort; additionally compare with non-BFR interval/HIIT conditions to evaluate safety and immediate effects. 3. Eight-week training adaptations and performance following BFR interval training Compare with vs. without BFR low-intensity slide-board interval training over 8 weeks on VO?max, anaerobic performance, muscular adaptations (strength/endurance), and timed performance; benchmark against HIIT to determine long-term applicability and potential benefits in sport-specific contexts. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
1.年龄 17–22 岁的速度滑冰运动员; 2.运动等级为国家二级及以上(大学生速度滑冰运动员,运动等级二级及以上); 3.体重指数(BMI) < 30 kg/m2;(如因肌肉量偏高导致 BMI 略高者,结合体脂率与代谢指标综合评估后决定是否纳入); 4.静息血压 < 140/90 mmHg;(如血压 130–139/85–89 mmHg,需经临床医师评估后方可参加;) 5.无心脏病或潜在血栓形成风险; 6.无神经肌肉、血液学或肌肉骨骼异常病史及其他可能影响研究的慢性疾病; 7.不吸烟; 8.自愿参与研究并签署知情同意书。 |
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Inclusion criteria |
1.Speed skaters aged 17–22 years; 2.Sports qualification at or above National Level II (including collegiate speed skaters with Level II or higher qualification); 3.Body mass index (BMI) < 30 kg/m^2; (if BMI is slightly higher due to increased muscle mass, eligibility will be determined based on body fat percentage and metabolic indicators;) 4.Resting blood pressure < 140/90 mmHg; (if blood pressure is 130–139/85–89 mmHg, participation requires clearance from a clinical physician;) 5.No history of cardiovascular disease or risk of thrombosis; 6.No history of neuromuscular, hematological, or musculoskeletal disorders, or other chronic diseases that may affect the study; 7.Non-smoker; 8.Voluntary participation with signed informed consent. |
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排除标准: |
1.评估为高风险或不适合进行有氧训练的个体(根据体育活动准备问卷 PAR-Q 和国际体力活动问卷 IPAQ 筛查); 2.正在服用或近期服用可能影响研究结果的药物或营养补充剂者; 3.存在肌肉骨骼损伤的受试者; 4.有严重心血管疾病、呼吸系统疾病或骨骼肌肉系统疾病病史者; 5.最近三个月内接受过重大手术或遭受严重损伤者; 6.不愿签署知情同意书者。 |
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Exclusion criteria: |
1.Individuals assessed as high risk or unsuitable for aerobic exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q) and the International Physical Activity Questionnaire (IPAQ); 2.Current or recent use of medications or nutritional supplements that may influence study outcomes; 3.Presence of musculoskeletal injuries; 4.History of severe cardiovascular, respiratory, or musculoskeletal disorders; 5.Major surgery or serious injury within the past three months; 6.Refusal to provide written informed consent. |
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研究实施时间: Study execute time: |
从 From 2024-05-25 00:00:00至 To 2025-08-30 00:00:00 |
征募观察对象时间: Recruiting time: |
从From 2024-05-28 00:00:00 至 To 2024-06-20 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 /Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
研究人员使用计算机随机数表法生成随机分组序列,由与干预无关的独立研究人员保管分组结果。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
The random allocation sequence was generated by a computer random number table and was managed by an independent researcher not involved in the intervention. |
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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 |
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盲法: |
本研究无法对受试者和训练人员实施盲法,但数据分析人员在不知分组的情况下进行统计分析。 |
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Blinding: |
Blinding of participants and trainers was not feasible due to the nature of the intervention; however, outcome assessors and statisticians were blinded to group allocation. |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
Yes |
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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): |
本研究的原始数据计划在主要研究结果发表后 6 个月内开放共享。 共享方式:通过临床试验公共管理平台 ResMan(www.medresman.org)对本研究的去标识化个体参与者数据(IPD)及相关数据说明进行公示,但不提供直接下载。 任何有合理学术需求的研究者,在获得伦理委员会批准且不侵犯受试者隐私的前提下,可通过电子邮件联系本研究负责人(kf007123@163.com )申请获取相关去标识化数据。 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
The raw data of this study (de-identified individual participant data, IPD) will be available for sharing within 6 months after publication of the primary study results. Data sharing method: De-identified IPD and related data documentation will be registered and publicly listed on the clinical trial public management platform ResMan (www.medresman.org ), but direct download will not be provided. Researchers with reasonable academic requests may obtain access to the de-identified IPD by contacting the principal investigator via e-mail (kf007123@163.com ), after approval from an ethics committee and under the condition that participants’ privacy is not compromised. |
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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: |
研究数据通过纸质病例记录表(CRF)采集,并录入 Excel 电子表格进行管理,定期进行双人核对和备份。所有数据保存在受密码保护的计算机中,仅研究团队可访问。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Data were collected using paper Case Report Forms (CRFs) and managed in electronic spreadsheets (Excel). Double-entry verification and regular backups were performed. All data were stored on password-protected computers accessible only to the research team. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |