ChiCTR2500112659 版本V1.0 版本创建时间2025/11/23 11:43:26 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：

ChiCTR2500112659 

最近更新日期：

Date of Last Refreshed on：

2025-11-18 09:47:44 

注册时间：

Date of Registration：

2025-11-18 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

血流限制低阻训练对骨关节炎半月板损伤关节镜术后早期康复的影响研究

Public title：

A study of the effect of blood flow limiting low resistance training on early rehabilitation after arthroscopic surgery for osteoarthritic meniscal injuries

注册题目简写：

English Acronym：

研究课题的正式科学名称：

血流限制低阻训练对骨关节炎半月板损伤关节镜术后早期康复的影响研究

Scientific title：

A study of the effect of blood flow limiting low resistance training on early rehabilitation after arthroscopic surgery for osteoarthritic meniscal injuries

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：

吴慧慧 

研究负责人：

王治 

Applicant：

Wu Huihui  

Study leader：

Wang Zhi 

申请注册联系人电话：

Applicant telephone：

+86 188 2712 2153

研究负责人电话：

Study leader's telephone：

+86 135 6468 3656

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：

w3050187880@163.com

研究负责人电子邮件：

Study leader's E-mail：

drwangzhi3656@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：

中国上海市浦东新区苗圃路219号

研究负责人通讯地址：

中国上海市浦东新区苗圃路219号

Applicant address：

219 Miao Pu Road, Pudong New Area, Shanghai, China

Study leader's address：

219 Miao Pu Road, Pudong New Area, Shanghai, 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：

上海理工大学

Applicant's institution：

University of Shanghai for Science and Technology

研究负责人所在单位：

上海浦东新区公利医院

Affiliation of the Leader：

Shanghai Pudong New Area Gongli Hospital

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：

GLYYls2025-057

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：

上海浦东新区公利医院伦理委员会

Name of the ethic committee：

Ethics Committee, Gongli Hospital, Pudong New District, Shanghai, China

伦理委员会批准日期：

Date of approved by ethic committee：

2025-09-09 00:00:00

伦理委员会联系人：

张灵

Contact Name of the ethic committee：

Zhang Ling

伦理委员会联系地址：

中国上海市浦东新区苗圃路219号

Contact Address of the ethic committee：

219 Miao Pu Road, Pudong New Area, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 135 6440 0702

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：

上海浦东新区公利医院

Primary sponsor：

Shanghai Pudong New Area Gongli Hospital

研究实施负责（组长）单位地址：

中国上海市浦东新区苗圃路219号

Primary sponsor's address：

219 Miao Pu Road, Pudong New Area, Shanghai, 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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海浦东新区公利医院

具体地址：

中国上海市浦东新区苗圃路219号

Institution
hospital：

Shanghai Pudong New Area Gongli Hospital

Address：

219 Miao Pu Road, Pudong New Area, Shanghai, China

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

Target disease：

degenerative meniscus injury

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

骨关节炎（osteoarthritis, OA）是一种对关节软骨和软骨下骨产生不可逆损伤的慢性关节疾病，关节疼痛和关节活动受限是 OA 最常见的临床症状，并伴有肌肉无力和关节周围肌肉萎缩。据文献报道，目前全球已超3亿患有OA，而我国40岁以上人群原发性OA的总体患病率已高达46.3%，其中女性OA患病和发病风险明显高于男性[1]。骨关节炎常好发于负重较大的膝关节、髋关节。研究证明，膝关节周围的肌肉萎缩是膝骨关节炎发生的高危因素。全球有近 1 亿人因膝骨关节炎致残，是第四大致残疾病，我国症状性膝骨关节炎的患病率约为14.6%，已成为致残最常见的疾病之一[2]。OA 高发病率和致残率给患者、家庭和社会造成巨大的经济负担。 根据骨关节炎诊疗指南中表示需要进行抗阻训练来增强肌力。肌少症和骨关节炎都无特效的药物进行治疗，因此阻力训练是常用干预方式之一，是通过促进肌肉蛋白质合成和肌肉生长来抑制肌肉损失的重要干预措施，定期的阻力训练可通过扩大肌纤维和增加横截表面积来加强运动表现。此外，由于在这一群体中参与肌肉蛋白质合成的 mTOR 信号传导水平较低，因此简单的阻力训练对老年人的效果可能较差。 高强度阻力训练（high-intensity resistance training, HIRT）被认为是通过增加骨骼肌质量和大小来刺激肌肉肥大从而预防肌肉萎缩的一种有效方法。关节疼痛作为OA最常见的临床表现，发生率为36.8%-60.7%，HIRT由于其训练强度大，极易引起再次的疼痛和炎症。骨关节炎患者大部分为老年人，对于老年患者来说，70%-85% 1RM 的HIRT训练强度大，难度大，很难长期坚持。而单纯的低负荷抗阻训练很难达到肌肉量增加的效果。 目前国际上认为血流限制联合低阻训练（blood flow restriction and low-intensity resistance training, BFR-LIRT）可以作为HIRT的代替方法。血流限制是一种起源于日本的新型的训练方式，包括在运动期间部分限制动脉流入和完全阻断静脉回流[3]，通常限制部位为肢体近端，也就是说，将压力控制在可以限制静脉回流而允许动脉在运动时流入的水平[4]。在运动中维持袖带压力可以实现短暂的缺血，这样的缺血可能会诱导血管内皮生长、刺激血管新生、提高代谢、增加肌细胞的水含量而导致细胞肿胀以及通过一系列反应来促进肌肉肥大[5]。血流限制训练可以很好的模拟高负荷阻力训练之后肌肉对静脉的挤压作用，因此和低负荷抗阻训练联合可以达到和高负荷抗阻训练相似的效果 。 BFR-LIRT通过袖带加压限制血流，避免HIRT训练的损伤风险，仅用低强度阻力训练就达到增加肌肉力量和体积的效果。在体育训练中，BFR-LIRT显示出巨大的潜力，能提升肌肉功能，为肌肉骨骼康复提供新思路。研究显示，BFR-LIRT在男子手球运动员中的应用效果与HIRT相当，甚至在某些方面更优[6]。同时，BFR-LIRT期间及之后，疼痛和感知的劳累程度较低，产生的肌肉适应性较好[7]。由于这些有利因素，使BFR-LIRT在治疗OA患者中的拥有巨大潜力。 先前的临床研究表明，血流限制联合低强度阻力训练在增强肌肉大小、力量、耐力以及有氧能力等方面具有协同作用，类似于 HIRT的效果[8]。BFR-LIRT可产生与 HIRT 水平相似的明显的代谢反应，产生的代谢副产物包括乳酸、双质子磷酸盐、脱氧血红蛋白、无机磷酸盐以及氢离子等物质。多项临床研究结果显示，BFR-LIRT在患有膝关节炎的老年女性以及终末期膝关节炎患者中表现为肌肉肥大、肌肉力量、关节稳定性的显著改善并实现缓解疼痛的有益效应[9]。 代谢应激和机械张力被认为是 BFR 过程中引起肌肉肥大的两种主要机制，它们可以发出诱导肌肉生长的多种信号，如机械传导、肌肉损伤、全身或局部激素的产生、细胞肿胀、活性氧及其变异体的产生，包括一氧化氮和热休克蛋白[10]。 然而，肌肉肥大的程度并不是由机械应力唯一决定的。从组织学水平的研究上看，肌肉萎缩归因于肌肉质量和肌纤维大小的减少，这两者的调节本质上反映了蛋白质周转（protein turnover）的状态。当蛋白质降解的速度超过蛋白质合成的速度时，产生肌肉萎缩的结果，而当蛋白质合成速率超过蛋白质降解的速率时，则产生肌肉肥大的结果，研究表明，BFR-LIRT会促进与肌肉相关的MyoD 和 myogenin等蛋白的表达，降低myostatin、leptin等与肌肉分解相关蛋白的表达，使蛋白质总体合成大于分解。因此，在选择 BFR 与不同运动强度之间的优化组合时应考虑最大限度地促进肌肉细胞中蛋白质的合成来预防临床环境中的肌肉萎缩。研究证明BFR-LIRT通常选择完全闭塞动脉血流压力值（AOP）的50%—80%，最佳AOP为60%，训练负荷一般选择20%—40%1RM，组间间歇时间一般安排30—60秒[11]。 尽管如此，BFR-LIRT尚未被建议作为膝关节炎关节镜术后的治疗方法之一，BFR-LIRT的分子机制也尚不明确，仍需要随机对照临床试验的临床论证。  

Objectives of Study：

Osteoarthritis (OA) is a chronic joint disease that causes irreversible damage to articular cartilage and subchondral bone. Joint pain and limited joint motion are the most common clinical symptoms of OA, accompanied by muscle weakness and periarticular muscle atrophy. According to the literature, more than 300 million people worldwide suffer from OA, and the overall prevalence of primary OA in people over 40 years of age in China is as high as 46.3%, with the risk of OA in women significantly higher than that in men [1]. Osteoarthritis often occurs in the knee and hip joints, which are heavily loaded. Studies have proven that muscle atrophy around the knee joint is a high risk factor for the development of knee osteoarthritis. Nearly 100 million people worldwide are disabled by knee osteoarthritis, which is the fourth most disabling disease, and the prevalence of symptomatic knee osteoarthritis in China is about 14.6%, which has become one of the most common diseases causing disability [2].OA High incidence and disability rates cause a huge economic burden to patients, families, and society. According to the guidelines for the management of osteoarthritis, it is indicated that resistance training is needed to enhance muscle strength. There are no specific drugs for the treatment of both sarcopenia and osteoarthritis, therefore resistance training is one of the commonly used interventions and is an important intervention to inhibit muscle loss by promoting muscle protein synthesis and muscle growth.Regular resistance training enhances athletic performance by enlarging the muscle fibres and increasing the cross-sectional surface area. In addition, simple resistance training may be less effective in older adults due to lower levels of mTOR signalling involved in muscle protein synthesis in this group. High-intensity resistance training (HIRT) is considered to be an effective method of preventing muscle atrophy by stimulating muscle hypertrophy through increasing skeletal muscle mass and size. Joint pain, the most common clinical manifestation of OA, occurs in 36.8%-60.7% of cases, and HIRT is highly susceptible to reoccurring pain and inflammation due to the high intensity of its training. The majority of osteoarthritis patients are elderly, and for elderly patients, 70%-85% 1RM of HIRT training is intense and difficult to adhere to for a long period of time. And it is difficult to achieve the effect of muscle mass increase with simple low load resistance training. Currently, blood flow restriction and low-intensity resistance training (BFR-LIRT) is considered internationally as an alternative to HIRT. Blood flow restriction is a novel training modality originating in Japan that consists of partially restricting arterial inflow and completely blocking venous return during exercise [3], and the site of restriction is usually the proximal limb, i.e., the pressure is controlled at a level that restricts venous return while allowing arterial inflow during exercise [4]. Maintaining cuff pressure during exercise allows for transient ischaemia, and such ischaemia may induce vascular endothelial growth, stimulate neovascularisation, increase metabolism, increase the water content of myocytes leading to cellular swelling as well as promote muscle hypertrophy through a range of responses [5]. Blood flow restriction training can be a good simulation of the muscular compression of veins following high load resistance training, and therefore in combination with low load resistance training can achieve similar results to high load resistance training . BFR-LIRT restricts blood flow through cuff compression, avoiding the risk of injury associated with HIRT training, and achieving increased muscle strength and volume with only low-intensity resistance training. In sports training, BFR-LIRT shows great potential to enhance muscle function and provide new ideas for musculoskeletal rehabilitation. Studies have shown that the effect of BFR-LIRT in male handball players is comparable to that of HIRT, and even superior in some aspects [6]. At the same time, pain and perceived exertion are lower during and after BFR-LIRT, producing better muscle adaptation [7]. Due to these favourable factors, it makes BFR-LIRT possess great potential in the treatment of OA patients. Previous clinical studies have shown that blood flow restriction combined with low-intensity resistance training has a synergistic effect on enhancing muscle size, strength, endurance, and aerobic capacity, similar to the effects of HIRT [8].BFR-LIRT produces a significant metabolic response similar to HIRT levels, generating metabolic by-products that include lactic acid, bisphosphonates, deoxyhaemoglobin, inorganic phosphates, and hydrogen ions, among other substances. The results of several clinical studies have shown that BFR-LIRT demonstrates significant improvements in muscle hypertrophy, muscle strength, joint stability, and beneficial effects on pain relief in older women with knee osteoarthritis and in patients with end-stage knee osteoarthritis [9]. Metabolic stress and mechanical tension are considered to be the two main mechanisms involved in the BFR process to cause muscle hypertrophy, and they can send out a variety of signals that induce muscle growth, such as mechanical transmission, muscle damage, systemic or local hormone production, cell swelling, and the production of reactive oxygen species and their variants, including nitric oxide and heat shock proteins [10]. However, the degree of muscle hypertrophy is not uniquely determined by mechanical stress. From studies at the histological level, muscle atrophy is attributed to a reduction in muscle mass and muscle fibre size, the regulation of which essentially reflects the state of protein turnover. When the rate of protein degradation exceeds the rate of protein synthesis, muscle atrophy results, while when the rate of protein synthesis exceeds the rate of protein degradation, muscle hypertrophy results. Studies have shown that BFR-LIRT promotes the expression of proteins such as MyoD and myogenin, which are related to muscle, and reduces the expression of proteins such as myostatin and leptin, which are related to muscle breakdown. related proteins such as myostatin and leptin, resulting in an overall greater protein synthesis than catabolism. Therefore, the optimal combination of BFR with different exercise intensities should be chosen to maximise protein synthesis in muscle cells to prevent muscle atrophy in the clinical setting. Studies have demonstrated that BFR-LIRT is usually selected at 50%-80% of the value of blood flow pressure (AOP) in completely occluded arteries, with an optimal AOP of 60%, training loads are usually selected at 20%-40% 1RM, and inter-set intervals are usually scheduled for 30-60 seconds [11]. Nevertheless, BFR-LIRT has not yet been suggested as one of the therapeutic options after arthroscopic surgery for knee osteoarthritis, and the molecular mechanism of BFR-LIRT is not yet clear, and clinical demonstration in randomised controlled clinical trials is still needed.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄>=50 岁； 2.符合膝骨关节炎半月板损伤的诊断标准； 3.接受关节镜术后1月； 4.自愿参加研究，并签署知情同意书

Inclusion criteria

1. Age >= 50years 2. Fulfilment of diagnostic criteria for osteoarthritic meniscal injuries of the knee; 3.1 month after undergoing arthroscopy; 4. Voluntarily participated in the study and signed an informed consent form.

排除标准：

1.急性深静脉血栓形成或凝血障碍； 2.不可控的高血压等心血管疾病； 3.因3个月内急性外伤导致的半月板损伤患者； 4.存在严重外周血管或周围神经病变； 5.存在运动禁忌； 6.存在中风、颅脑手术、重度抑郁或严重认知障碍等影响 执行运动训练的疾病； 7.活动性癌症； 8.同时参与了其它运动计划。

Exclusion criteria：

1. Acute deep vein thrombosis or coagulation disorders; 2. Cardiovascular diseases such as uncontrollable hypertension; 3. Patients with meniscal injuries due to acute trauma within 3 months; 4. Presence of severe peripheral vascular or peripheral neuropathy; 5. Exercise contraindications exist; 6. Illnesses such as stroke, cranio-cerebral surgery, major depression, or severe cognitive impairment that interfere with the performance of exercise training; 7. Active cancer; 8. oncurrent participation in other exercise programme.

研究实施时间：

Study execute time：

从 From 2025-08-01 00:00:00至 To 2025-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-08-01 00:00:00 至 To 2025-12-30 00:00:00  

干预措施：

Interventions：

组别：

BFR-LIRT组

样本量：

20

Group：

BFR-LIRT group

Sample size：

干预措施：

受试者取坐位，取约 10 厘米的充气袖带绑在大腿近侧腹股沟处，用超声探头寻找胫后动脉，测量 30 秒静息状态动脉血流。随后袖带充气到 50mmHg ，持续 30 秒后放气 10 秒，随后按同样的时间充气、放气，每次充气比前一次增加 30mmHg ，直到血流消失，动脉完全闭塞。接下来，压力每次减少 10mmHg 直到重新出现血流，随后每次减 1mmHg 直到不再能检测到血流，此时的袖带压力为动脉闭塞压力（AOP）。测定 AOP 后袖带放气，受试者休息 5 分钟。 在受试者对应的血流限制部位捆绑袖带，加压至60% AOP，受试者取坐位，运动中尽可能不移动身体和躯干。首先进行几次热身运动，随后开始正式运动。正式运动包括 4 组坐位膝伸展运动，第 1 组 30 次重复，第 2-4 组 15 次重复，每组间休息 1 分钟。共锻炼 6 周，每周 2 次，每次锻炼间至少间隔48小时。

干预措施代码：

Intervention：

Subjects sit in a seated position. A 10-cm inflatable cuff is placed on the proximal thigh at the inguinal region. Using an ultrasound probe, the posterior tibial artery is identified, and 30 seconds of resting arterial blood flow is measured. The cuff is then inflated to 50 mmHg for 30 seconds, followed by deflation for 10 seconds. This cycle of inflation and deflation is repeated, with each subsequent inflation pressure increased by 30 mmHg until blood flow disappears and the artery is completely occluded. Pressure is then reduced by 10 mmHg increments until blood flow reappears, followed by 1 mmHg decrements until blood flow can no longer be detected; the cuff pressure at this point is defined as the arterial occlusion pressure (AOP). After measuring AOP, the cuff is fully deflated, and subjects rest for 5 minutes. Subsequently, a cuff is applied to the corresponding limb region and inflated to 60% of the previously determined AOP. Subjects remain seated during exercise, minimizing movement of the body and trunk. Several warm-up exercises are performed first, followed by the formal exercise protocol: four sets of seated knee extensions, with the first set consisting of 30 repetitions and sets 2–4 consisting of 15 repetitions each, with 1-minute rest between sets. The exercise intervention lasts for 6 weeks, conducted twice per week, with at least 48 hours between each session.

Intervention code：

组别：

LIRT组

样本量：

20

Group：

LIRT group

Sample size：

干预措施：

受试者取坐位，运动中尽可能不移动身体和躯干。首先进行几次热身运动，随后开始正式运动。正式运动包括 4 组坐位膝伸展运动，第 1 组 30 次重复，第 2-4 组 15 次重复，每组间休息 1 分钟。对照组进行常规干预，不进行 BFR 和 LIRT 。共锻炼 6 周，每周 2 次，每次锻炼间至少间隔48小时。

干预措施代码：

Intervention：

Subjects remain seated during exercise with minimal movement of the body and trunk. Several warm-up exercises are performed first, followed by the formal exercise protocol, which consists of four sets of seated knee extensions: the first set includes 30 repetitions, and sets 2–4 include 15 repetitions each, with 1-minute rest between sets. The control group receives conventional intervention without BFR or LIRT. The exercise intervention lasts for 6 weeks, conducted twice per week, with at least 48 hours between sessions.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

上海浦东新区公利医院 

单位级别：

三甲 

Institution
hospital：

Shanghai Pudong New Area Gongli Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

股四头肌肌力

指标类型：

主要指标

Outcome：

Quadriceps muscle strength

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

握力

指标类型：

次要指标

Outcome：

Grip strength

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

步速测试

指标类型：

次要指标

Outcome：

Pace test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

骨骼肌质量指数

指标类型：

次要指标

Outcome：

Skeletal muscle mass index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌肉横截面积检查

指标类型：

次要指标

Outcome：

Muscle cross-sectional area examination

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

膝关节关节活动度

指标类型：

次要指标

Outcome：

Knee joint range of motion

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 50 岁 years
最大 Max age 90 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）：

随机化分为试验组和对照组

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

Randomized into trial and control groups.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

未提及

Blinding：

Not stated

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）：

公布平台：国家生物信息中心（https://ngdc.cncb.ac.cn/gsub/），公布原始数据的时间预计为研究结束的6个月内

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

Publishing platform: National Center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/), the original data is expected to be published within 6 months after the completion of the study.

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：

数据采集：电子病历系统提取，直接测量，问卷调查 数据管理：数据算录入

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

Data collection: electronic medical record system extraction, direct measurement, questionnaire survey Data management: data count entry

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-11-18 09:47:44