ChiCTR2500109329 版本V1.0 版本创建时间2025/09/16 17:52:15 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500109329 

最近更新日期：

Date of Last Refreshed on：

2025-09-16 17:52:06 

注册时间：

Date of Registration：

2025-09-16 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

非侵入性磁刺激对下肢抗阻训练后疲劳恢复以及运动表现的影响研究

Public title：

Effects of non-invasive magnetic stimulation on fatigue recovery after lower extremity resistance training and on athletic performance

注册题目简写：

English Acronym：

研究课题的正式科学名称：

非侵入性磁刺激对下肢抗阻训练后疲劳恢复以及运动表现的影响研究

Scientific title：

Effects of non-invasive magnetic stimulation on fatigue recovery after lower extremity resistance training and on athletic performance

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：

尹筱涵 

研究负责人：

尹筱涵 

Applicant：

Yin Xiaohan 

Study leader：

Yin Xiaohan 

申请注册联系人电话：

Applicant telephone：

+86 198 6213 2855

研究负责人电话：

Study leader's telephone：

+86 198 6213 2855

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：

yinxiaohan0925@163.com

研究负责人电子邮件：

Study leader's E-mail：

yinxiaohan0925@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：

北京市海淀区信息路48号北京体育大学

研究负责人通讯地址：

北京市海淀区信息路48号北京体育大学

Applicant address：

No. 48, Information Road, Haidian District, Beijing Sport University, Beijing, China

Study leader's address：

No. 48, Information Road, Haidian District, Beijing Sport University, Beijing, China

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：

北京体育大学

Applicant's institution：

Beijing Sport University

研究负责人所在单位：

北京体育大学

Affiliation of the Leader：

Beijing Sport University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025259H

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：

北京体育大学运动科学实验伦理委员会

Name of the ethic committee：

Ethics Committee of Sports Science Experiment, Beijing Sport University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-05 00:00:00

伦理委员会联系人：

梅涛

Contact Name of the ethic committee：

Mei Tao

伦理委员会联系地址：

北京市海淀区信息路48号

Contact Address of the ethic committee：

No. 48, Information Road, Haidian District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 6298 9306

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：

北京体育大学

Primary sponsor：

Beijing Sport University

研究实施负责（组长）单位地址：

北京市海淀区信息路48号

Primary sponsor's address：

No. 48, Information Road, Haidian District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

海淀区

Country：

China

Province：

Beijing

City：

Haidian

单位(医院)：

北京体育大学

具体地址：

北京市海淀区信息路48号

Institution
hospital：

Beijing Sport University

Address：

No. 48, Information Road, Haidian District, Beijing, China

经费或物资来源：

自筹经费

Source(s) of funding：

Self-raised funds

Target disease：

Exercise fatigue

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：

随机交叉对照 

Study design：

Cross-over 

研究目的：

本研究旨在通过与静态拉伸+泡沫轴按摩、静坐休息两种方法进行对比，探讨PMS对运动疲劳恢复和运动表现的影响，量化不同恢复策略的影响，同时研究不同刺激频率（10Hz vs. 20Hz）效果的差异。我们假设 PMS干预可能比静态拉伸与泡沫轴组合干预(SFR)和静坐休息(CON)更能有效加速疲劳恢复，提高运动表现。不同频率的磁刺激可能在效果上存在差异，其中较高频率（20Hz）可能比较低频率（10Hz）更有效  

Objectives of Study：

This study aimed to examine the effects of PMS on fatigue recovery and athletic performance by comparing it with two commonly used recovery strategies—static stretching combined with foam rolling (SFR group) and sedentary rest (CON group)—to quantify the effects of different recovery protocols and investigate the differences in effectiveness between stimulation frequencies (10 Hz vs. 20 Hz). Additionally, we sought to determine whether different stimulation frequencies (10 Hz vs. 20 Hz) elicit differential effects. We hypothesized that PMS would be more effective in promoting fatigue recovery and improving athletic performance compared to SFR and CON. Furthermore, we expected that higher-frequency stimulation (20 Hz) would yield superior outcomes relative to lower-frequency stimulation (10 Hz).

药物成份或治疗方案详述：

PMS20Hz干预： 受试者平躺在实验床上，身体自然放松，以最大程度减少非特异性肌肉收缩的影响，为了使受试者在疲劳恢复期间能够获得外周磁刺激的生理促进效应，使用了具有1.8 Tesla的脉冲电磁感应场的磁刺激仪器。频率为20Hz，作用于股四头肌区域，持续20分钟，强度设定为受试者的最大可耐受程度，以确保达到肌肉兴奋但不会引起不适的水平。使用固定带将手柄连接到肌肉皮肤，以确保对股四头肌的最佳刺激。 静态拉伸与泡沫轴组合干预： 静态拉伸要求受试者采用弓箭步支撑位，前腿（左腿）膝踝关节保持 90° 角度，后腿（右腿）膝关节屈曲，以髌骨上缘为支撑点。受试者用右手拉住右踝，保持骨盆和躯干中立位，目视前方，持续拉伸至股四头肌前侧产生中等酸胀感，然后保持30秒。左右腿交替进行，总时长3分钟。 泡沫轴滚压要求受试者采用俯卧位，双肘支撑地面，确保身体保持水平位。泡沫轴置于 大腿前侧中点（股直肌区域），双腿并拢，与泡沫轴垂直。受试者缓慢进行 股直肌的滚压练习，使双腿沿泡沫轴表面 反复滚动，确保肌肉得到充分放松。 静坐休息干预： 在控制条件下受试者保持20分钟的静态坐姿休息。 PMS10Hz干预： 受试者平躺在实验床上，身体自然放松，以最大程度减少非特异性肌肉收缩的影响，为了使受试者在疲劳恢复期间能够获得外周磁刺激的生理促进效应，使用了具有1.8 Tesla的脉冲电磁感应场的磁刺激仪器。频率为10Hz，作用于股四头肌区域，持续20分钟，强度设定为受试者的最大可耐受程度，以确保达到肌肉兴奋但不会引起不适的水平。使用固定带将手柄连接到肌肉皮肤，以确保对股四头肌的最佳刺激。 静态拉伸与泡沫轴组合干预： 静态拉伸要求受试者采用弓箭步支撑位，前腿（左腿）膝踝关节保持 90° 角度，后腿（右腿）膝关节屈曲，以髌骨上缘为支撑点。受试者用右手拉住右踝，保持骨盆和躯干中立位，目视前方，持续拉伸至股四头肌前侧产生中等酸胀感，然后保持30秒。左右腿交替进行，总时长3分钟。 泡沫轴滚压要求受试者采用俯卧位，双肘支撑地面，确保身体保持水平位。泡沫轴置于 大腿前侧中点（股直肌区域），双腿并拢，与泡沫轴垂直。受试者缓慢进行 股直肌的滚压练习，使双腿沿泡沫轴表面 反复滚动，确保肌肉得到充分放松。 静坐休息干预： 在控制条件下受试者保持20分钟的静态坐姿休息。 

Description for medicine or protocol of treatment in detail：

PMS 20Hz intervention: Participants lay flat on the experimental bed with their bodies naturally relaxed to minimize the influence of non-specific muscle contractions. To enable participants to experience the physiological promotional effects of peripheral magnetic stimulation during fatigue recovery, a magnetic stimulation device equipped with a 1.8 Tesla pulsed electromagnetic induction field was used. The frequency was set to 20 Hz, applied to the quadriceps region for 20 minutes, with intensity adjusted to the maximum level tolerable by the participant to ensure muscle excitation without causing discomfort. Handles were secured to the muscle skin using straps to ensure optimal stimulation of the quadriceps. Static stretching combined with foam roller intervention: Static stretching required participants to assume a lunge position, with the front leg (left leg) knee and ankle joints maintained at a 90° angle, and the rear leg (right leg) knee flexed, using the upper edge of the patella as a support point. The subject holds the right ankle with the right hand, maintains a neutral pelvic and trunk position, looks straight ahead, and continues the stretch until a moderate burning sensation is felt on the anterior side of the quadriceps, then holds for 30 seconds. Alternate between the left and right legs, with a total duration of 3 minutes. Foam roller rolling requires the subject to assume a prone position, with both elbows supporting the ground, ensuring the body remains horizontal. The foam roller is placed on the mid-front of the thigh (rectus femoris area), with both legs together and perpendicular to the foam roller. The subject slowly performs rectus femoris rolling exercises, repeatedly rolling both legs along the surface of the foam roller to ensure adequate muscle relaxation. Seated rest intervention: Under controlled conditions, the subject maintains a static seated rest position for 20 minutes PMS 10Hz intervention: Participants lay flat on the experimental bed with their bodies naturally relaxed to minimize the influence of non-specific muscle contractions. To enable participants to receive the physiological promotional effects of peripheral magnetic stimulation during fatigue recovery, a magnetic stimulation device with a 1.8 Tesla pulsed electromagnetic induction field was used. The frequency was set to 10 Hz, applied to the quadriceps region for 20 minutes, with intensity adjusted to the participant's maximum tolerable level to ensure muscle excitation without causing discomfort. Handles were secured to the muscle skin using straps to ensure optimal stimulation of the quadriceps. Static stretching combined with foam roller intervention: Static stretching required participants to assume a lunge position, with the front leg (left leg) knee and ankle joints maintained at a 90° angle, and the rear leg (right leg) knee joint flexed, using the upper edge of the patella as the support point. The subject holds the right ankle with the right hand, maintains a neutral pelvic and trunk position, looks straight ahead, and continues the stretch until a moderate burning sensation is felt in the anterior aspect of the quadriceps, then holds for 30 seconds. Alternate between the left and right legs, with a total duration of 3 minutes. Foam roller rolling requires the subject to assume a prone position, with both elbows supporting the ground, ensuring the body remains in a horizontal position. The foam roller is placed at the midpoint of the anterior thigh (rectus femoris region), with both legs together and perpendicular to the foam roller. The subject slowly performs the rectus femoris rolling exercise, rolling both legs repeatedly along the surface of the foam roller to ensure adequate muscle relaxation. Seated rest intervention: Under controlled conditions, the subject maintains a static seated rest position for 20 minutes. 

纳入标准：

年龄为18～24岁；身体健康的男性；有规律的深蹲训练经验（≥3个月，每周≥2次），能够安全完成60%1RM深蹲训练；近3个月无下肢或腰部运动损伤史；无神经肌肉系统疾病或心血管禁忌症；对磁刺激设备无过敏或不适应反应。

Inclusion criteria

Ages 18–24; healthy males; experience with regular squat training (>= 3 months, >= 2 times per week), capable of safely performing 60% 1RM squat training; no history of lower limb or lumbar musculoskeletal injuries in the past 3 months; no neuromuscular disorders or cardiovascular contraindications; no allergies or adverse reactions to magnetic stimulation devices.

排除标准：

有下肢关节（特别是膝关节、踝关节）或腰部的急性或慢性损伤史（如前交叉韧带损伤、半月板损伤、肌腱撕裂、腰椎间盘突出等）；目前存在任何影响运动功能或安全完成深蹲训练的骨骼肌系统疾病；既往或当前有神经系统疾病、心脏病、癫痫、佩戴心脏起搏器等磁刺激禁忌症；有皮肤过敏、皮肤病或对电磁设备产生过敏反应；近期服用会影响肌肉功能或神经传导的药物。

Exclusion criteria：

History of acute or chronic injuries to the lower limb joints (particularly the knee and ankle joints) or the lumbar region (e.g., anterior cruciate ligament injury, meniscus injury, tendon rupture, lumbar disc herniation, etc.); Currently have any skeletal muscle system disorders that impair motor function or the safe performance of squat training; Have a history of or currently have neurological disorders, heart disease, epilepsy, or conditions contraindicated for magnetic stimulation (e.g., pacemaker use); Have skin allergies, skin conditions, or allergic reactions to electromagnetic devices; Have recently taken medications that affect muscle function or nerve conduction.

研究实施时间：

Study execute time：

从 From 2025-05-06 00:00:00至 To 2026-06-05 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-06-11 00:00:00 至 To 2025-09-15 00:00:00  

干预措施：

Interventions：

组别：

PMS20Hz组

样本量：

6

Group：

PMS20Hz Group

Sample size：

干预措施：

受试者均参与三次实验，除疲劳后利用磁刺激进行干预的实验以外，其他两次实验分别是静态拉伸与泡沫轴组合干预（SFR20Hz组）及静坐休息干预（CON20Hz组）的疲劳消除实验，每次实验之间间隔7天，三种疲劳消除方式干预时间均为20分钟。 实验采用经典股四头肌疲劳造模方法，为确保干预前后测量一致性，受试者在干预后需重复进行一组相同模式的深蹲，以量化不同恢复策略的影响。受试者热身后进行10组60%最大深蹲重量的负重深蹲，每组7次，组间休息2-3分钟。

干预措施代码：

Intervention：

All participants took part in three experiments. In addition to the experiment involving magnetic stimulation intervention after fatigue, the other two experiments were fatigue recovery experiments using static stretching combined with foam roller rolling (SFR20Hz group) and sitting rest intervention (CON20Hz group). There was a 7-day interval between each experiment, and the intervention duration for all three fatigue recovery methods was 20 minutes. The experiment employed a classic quadriceps fatigue modeling method. To ensure consistency in measurements before and after intervention, participants were required to repeat a set of identical squat movements post-intervention to quantify the effects of different recovery strategies. After warming up, participants performed 10 sets of weighted squats, with 7 repetitions per set, each set using 60% of their maximum squat weight, with 2–3 minutes of rest between sets. .

Intervention code：

组别：

PMS10Hz组

样本量：

6

Group：

PMS10Hz Group

Sample size：

干预措施：

受试者均参与三次实验，除疲劳后利用磁刺激进行干预的实验以外，其他两次实验分别是静态拉伸与泡沫轴组合干预（SFR10Hz组）及静坐休息干预（CON10Hz组）的疲劳消除实验，每次实验之间间隔7天，三种疲劳消除方式干预时间均为20分钟。 实验采用经典股四头肌疲劳造模方法，为确保干预前后测量一致性，受试者在干预后需重复进行一组相同模式的深蹲，以量化不同恢复策略的影响。受试者热身后进行10组60%最大深蹲重量的负重深蹲，每组7次，组间休息2-3分钟。

干预措施代码：

Intervention：

All participants took part in three experiments. Except for the experiment involving magnetic stimulation intervention after fatigue, the other two experiments were fatigue recovery experiments using static stretching combined with foam rolling (SFR 10Hz group) and seated rest intervention (CON 10Hz group), respectively. There was a 7-day interval between each experiment, and the intervention duration for all three fatigue recovery methods was 20 minutes. The experiment employed a classic quadriceps fatigue modeling method. To ensure consistency in measurements before and after intervention, participants were required to repeat a set of squats with the same pattern after intervention to quantify the effects of different recovery strategies. After warming up, participants performed 10 sets of weighted squats at 60% of their maximum squat weight, with 7 repetitions per set and 2–3 minutes of rest between sets.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京体育大学 

单位级别：

大学 

Institution
hospital：

Beijing Sports University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

主观疲劳程度评分

指标类型：

主要指标

Outcome：

Rating of perceived exertion

Type：

Primary indicator

测量时间点：

测量方法：

通过 Borg 6-20 RPE 量表

Measure time point of outcome：

Measure method：

Borg 6–20 scale

指标中文名：

大腿围度

指标类型：

主要指标

Outcome：

Thigh circumference

Type：

Primary indicator

测量时间点：

测量方法：

非弹性软尺

Measure time point of outcome：

Measure method：

A non-elastic measuring tape

指标中文名：

反向跳跃

指标类型：

主要指标

Outcome：

Countermovement Jump

Type：

Primary indicator

测量时间点：

测量方法：

使用 Hidrofit 装置

Measure time point of outcome：

Measure method：

The Hidrofit device (Hidrofit, Mina Gerais, Brazil)

指标中文名：

等长肌肉力量

指标类型：

主要指标

Outcome：

Isometric muscular strength

Type：

Primary indicator

测量时间点：

测量方法：

使用压力空气反馈仪Pressure Air Biofeedback测量

Measure time point of outcome：

Measure method：

The Pressure Air Biofeedback System?

指标中文名：

均方根振幅

指标类型：

主要指标

Outcome：

Root Mean Square

Type：

Primary indicator

测量时间点：

测量方法：

Delsys 16 导无线表面肌电

Measure time point of outcome：

Measure method：

Delsys 16-channel wireless surface electromyography system

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

Absent

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 15 岁 years
最大 Max age 25 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

在这项随机双盲交叉的研究中，将12名受试者随机均分为10Hz组（PMS10Hz组）与20Hz组（PMS20Hz组），随机化由未参与数据收集或分析的独立研究人员使用计算机生成的随机数随机分配。两组在形态、力量等各项指标间均无组间差异

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

In this randomized, double-blind, crossover study, 12 participants were randomly divided into a 10Hz group (PMS10Hz group) and a 20Hz group (PMS20Hz group). Randomization was performed by an independent researcher who was not involved in data collection or analysis, using computer-generated random numbers. There were no significant differences between the two groups in terms of morphology, strength, and other indicators.

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：

研究采用双盲设计：参与者不清楚自己的分组情况。三组受试者训练过程中使用外观一致的干预设备，并对其进行统一指导，避免泄露分组信息。研究结束后通过问卷调查评估盲法有效性，确保研究结果的科学性和可靠性。实验干预由未参与数据收集或分析的独立研究人员进行实施，干预过程中，实施者避免提及与分组相关的任何信息（如频率参数），确保受试者无法通过交流推测组别。

Blinding：

The study employed a double-blind design: participants were unaware of their group assignments. All three groups of participants used intervention devices with identical appearances during training and received uniform instructions to prevent disclosure of group information. The effectiveness of the blinded design was assessed through a questionnaire survey after the study concluded to ensure the scientific validity and reliability of the results. The experimental intervention was implemented by independent researchers who did not participate in data collection or analysis. During the intervention, the implementers avoided mentioning any information related to group assignment (such as frequency parameters) to ensure that participants could not infer their group assignment through communication.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

原始数据将于论文发表时通过 Open Science Framework (OSF) 存储库 公开共享（文章接受后将提供DOI 号码）。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The raw data will be made publicly available via the Open Science Framework (OSF) repository upon publication of the manuscript; the DOI will be provided upon acceptance of the article.

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：

病例记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form, CRF

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：

  2025-09-16 17:52:06