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血流限制联合功能训练对帕金森病患者日常生活能力、平衡与步态稳定性的随机对照研究
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注册号：

Registration number：

 ChiCTR2500109830 

最近更新日期：

Date of Last Refreshed on：

 2025-09-25 15:18:45 

注册时间：

Date of Registration：

 2025-09-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

血流限制联合功能训练对帕金森病患者日常生活能力、平衡与步态稳定性的随机对照研究

Public title：

A Randomized Controlled Trial of Blood Flow Restriction Combined with Functional Training on Activities of Daily Living, Balance, and Gait Stability in Patients with Parkinson's Disease

注册题目简写：

English Acronym：

研究课题的正式科学名称：

血流限制联合功能训练对帕金森病患者日常生活能力、平衡与步态稳定性的随机对照研究

Scientific title：

A Randomized Controlled Trial of Blood Flow Restriction Combined with Functional Training on Activities of Daily Living, Balance, and Gait Stability in Patients with Parkinson's Disease

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：

王保臣 

研究负责人：

王保臣 

Applicant：

Baochen Wang 

Study leader：

Baochen Wang 

申请注册联系人电话：

Applicant telephone：

 +86 138 2066 2560

研究负责人电话：

Study leader's
telephone：

+86 138 2066 2560

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：

 wangbc2560@163.com

研究负责人电子邮件：

Study leader's E-mail：

 wangbc2560@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：

天津市静海区团泊新城西区东海道16号

研究负责人通讯地址：

天津市静海区团泊新城西区东海道16号

Applicant address：

No.16 Donghai Road,West Tuanbo New Town,Jinghai District,Tianjin,P.R.China

Study leader's address：

No.16 Donghai Road,West Tuanbo New Town,Jinghai District,Tianjin,P.R.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：

天津体育学院

Applicant's institution：

Tianjin University of Sport

研究负责人所在单位：

天津体育学院

Affiliation of the Leader：

Tianjin University of Sport

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：

 2025-098

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：

天津体育学院伦理委员会

Name of the ethic committee：

Ethics Committee of Tianjin University of Sport

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-02 00:00:00

伦理委员会联系人：

覃洋洋

Contact Name of the ethic committee：

Yangyang Tan

伦理委员会联系地址：

天津市静海区团泊新城西区东海道16号

Contact Address of the ethic committee：

No.16 Donghai Road,West Tuanbo New Town,Jinghai District,Tianjin,P.R.China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 189 8310 0068

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：

天津体育学院

Primary sponsor：

Tianjin University of Sport

研究实施负责（组长）单位地址：

天津市静海区团泊新城西区东海道16号

Primary sponsor's address：

No.16 Donghai Road,West Tuanbo New Town,Jinghai District,Tianjin,P.R.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)：

天津

市(区县)：

Country：

China

Province：

Tianjin

City：

单位(医院)：

天津体育学院

具体地址：

天津市静海区团泊新城西区东海道16号

Institution
hospital：

Tianjin University of Sport

Address：

No.16 Donghai Road,West Tuanbo New Town,Jinghai District,Tianjin,P.R.China

经费或物资来源：

体育总局科教司国家队科技助力青年项目

Source(s) of funding：

The General Administration of Sport of China Science and Education Department National Team Youth Science and Technology Assistance Project

研究疾病：

帕金森  

Target disease：

Parkinson's disease

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

在轻—中度帕金森病人群中，采用三臂随机对照试验（BFR+功能训练、等量功能训练、对照），系统评估“低负荷血流限制（BFR）耦合任务特异功能训练”对日常生活能力（S&E、SRBI）、动态平衡（Mini-BESTest）、步行与移动能力（TUG、6MWT）及步态稳定性（步速/步时/步长及其变异系数CV）的疗效与安全性，明确其相较单纯功能训练与对照的增益幅度与稳定性，并验证其作为可推广康复处方的临床可行性。为此，本研究拟： （1）比较三组在主要结局（S&E、SRBI、Mini-BESTest、TUG、6MWT）上的干预效应； （2）量化步态时空参数及其CV的改变，检验“组别×时间”交互是否指向BFR+功能训练在稳定性维度上的附加优势； （3）评估不良事件与耐受性，验证在低机械负荷条件下实现更强训练刺激的安全可行性； （4）探索分期（H&Y）、基线步态变异性等因素对干预效应的潜在异质性，为处方个体化提供依据。  

Objectives of Study：

In individuals with mild-to-moderate Parkinson’s disease, a three-arm randomized controlled trial (BFR + functional training, volume-matched functional training alone, and control) will be conducted to systematically evaluate the efficacy and safety of "low-load blood flow restriction (BFR) combined with task-specific functional training" on activities of daily living (S&E, SRBI), dynamic balance (Mini-BESTest), walking and mobility (TUG, 6MWT), and gait stability (gait speed/step time/step length and their coefficients of variation, CV). The study aims to clarify the magnitude and consistency of additional benefits compared to functional training alone and control conditions, and to validate its clinical feasibility as a scalable rehabilitation protocol. To achieve this, the study intends to: (1) Compare the intervention effects among the three groups on primary outcomes (S&E, SRBI, Mini-BESTest, TUG, 6MWT); (2) Quantify changes in spatiotemporal gait parameters and their CVs, and examine whether the "group × time" interaction indicates additional advantages of BFR + functional training in terms of stability; (3) Assess adverse events and tolerance to verify the safety and feasibility of achieving stronger training stimuli under low mechanical load conditions; (4) Explore potential effect heterogeneity related to disease stage (H&Y), baseline gait variability, and other factors, to provide a basis for individualization of the intervention protocol.

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：

中重度抑郁或其他精神障碍；合并其他神经/肌骨疾病；不稳定心血管或代谢疾病；BFR 训练禁忌（如深静脉血栓、抗凝治疗等）；运动功能严重受限（如 DBS 植入、显著“开-关”波动）；近 3 个月参与系统性运动/试验；其他不宜安全参与训练的健康问题。

Exclusion criteria：

Individuals with moderate to severe depression or other psychiatric disorders; comorbid neurological or musculoskeletal diseases; unstable cardiovascular or metabolic conditions; contraindications to BFR training (e.g., deep vein thrombosis, anticoagulant therapy, etc.); severe motor limitations (e.g., DBS implantation, significant "ON-OFF" fluctuations); participation in structured exercise programs or clinical trials within the past 3 months; or any other health issues that may compromise safe participation in the training.

研究实施时间：

Study execute time：

从 From 2025-09-30 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-30 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

血流限制联合功能性训练组

样本量：

 11

Group：

Blood Flow Restriction Combined with Functional Training Group

Sample size：

干预措施：

本研究中对“血流限制+功能性训练组”（BFR+Func组）实施的干预措施如下：该组患者接受为期8周、每周3次（非连续日）、每次约60分钟的一对一督导训练。训练均安排在左旋多巴血药浓度高峰期（服药后1–1.5小时）进行，由具备帕金森病专科资质的治疗师指导。干预方案融合了低负荷血流限制（BFR）与任务导向的功能性训练：使用双侧大腿近端气压袖带（宽10 cm），压力设定为个体化肢体闭塞压（LOP）的60%，且每周通过多普勒超声复测LOP并调整压力；组间休息60秒时完全放气。功能性训练内容以改善日常生活活动、动态平衡及步态稳定性为核心，包括坐-站转移、步行/台阶训练和动态姿势控制任务。训练强度通过Borg RPE量表进行监控与调节，目标RPE维持在12–14之间，若RPE低于12则增加负荷，高于14则降低任务难度或安排休息。整个干预过程严格监测心率、RPE及任何不良事件，以确保方案安全性与耐受性。

干预措施代码：

Intervention：

The intervention protocol for the "Blood Flow Restriction + Functional Training" group (BFR+Func group) in this study was implemented as follows: Patients in this group received a supervised training program lasting 8 weeks, with three sessions per week (on non-consecutive days), each approximately 60 minutes long. All training sessions were conducted during the peak plasma concentration period of levodopa (1–1.5 hours after medication intake) and were guided one-on-one by physical therapists specialized in Parkinson's disease. The intervention combined low-load blood flow restriction (BFR) with task-oriented functional training: pneumatic cuffs (10 cm wide) were placed proximally on both thighs, with pressure set at 60% of individual limb occlusion pressure (LOP). LOP was reassessed weekly using Doppler ultrasound to adjust the pressure accordingly; cuffs were completely deflated during the 60-second rest intervals between sets. The functional training focused on improving activities of daily living, dynamic balance, and gait stability, including tasks such as sit-to-stand transitions, walking/stair climbing, and dynamic postural control exercises. Training intensity was monitored and adjusted using the Borg RPE scale, with a target RPE range of 12–14. If the RPE fell below 12, the load was increased; if it exceeded 14, task difficulty was reduced or rest was provided. Throughout the intervention, heart rate, RPE, and any adverse events were strictly monitored to ensure safety and tolerability of the protocol.

Intervention code：

组别：

功能性训练组

样本量：

 11

Group：

Functional Training Group

Sample size：

干预措施：

本研究中对“功能性训练组”（Func组）实施的干预措施如下：该组患者接受为期8周、每周3次（非连续日）、每次约60分钟的一对一督导训练。训练均安排在左旋多巴血药浓度高峰期（服药后1–1.5小时）进行，由具备帕金森病专科资质的治疗师指导。功能性训练内容以改善日常生活活动、动态平衡及步态稳定性为核心，包括坐-站转移、步行/台阶训练和动态姿势控制任务。训练强度通过Borg RPE量表进行监控与调节，目标RPE维持在12–14之间，若RPE低于12则增加负荷，高于14则降低任务难度或安排休息。整个干预过程严格监测心率、RPE及任何不良事件，以确保方案安全性与耐受性。

干预措施代码：

Intervention：

The intervention protocol for the "Functional Training" group (Func group) in this study was implemented as follows: Patients in this group received a supervised training program lasting 8 weeks, with three sessions per week (on non-consecutive days), each approximately 60 minutes long. All training sessions were conducted during the peak plasma concentration period of levodopa (1–1.5 hours after medication intake) and were guided one-on-one by physical therapists specialized in Parkinson’s disease. The functional training focused on improving activities of daily living, dynamic balance, and gait stability, including tasks such as sit-to-stand transitions, walking/stair climbing, and dynamic postural control exercises. Training intensity was monitored and adjusted using the Borg RPE scale, with a target RPE range of 12–14. If the RPE fell below 12, the load was increased; if it exceeded 14, task difficulty was reduced or rest was provided. Throughout the intervention, heart rate, RPE, and any adverse events were strictly monitored to ensure the safety and tolerability of the protocol.

Intervention code：

组别：

空白对照组

样本量：

 11

Group：

Control Group

Sample size：

干预措施：

保持原有的生活习惯不变

干预措施代码：

Intervention：

Maintain their usual lifestyle without any changes.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 天津市 

市(区县)：

  

Country：

China

Province：

Tianjin

City：

单位(医院)：

 天津体育学院 

单位级别：

 大学 

Institution
hospital：

Tianjin University of Sport

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

施瓦布和英格兰日常生活活动量表

指标类型：

主要指标

Outcome：

Schwab & England Activities of Daily Living Scale (S&E)

Type：

Primary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

采用标准化量表评估，由经过培训的评估者面对面施测。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Standardized scale assessment, administered face-to-face by trained assessors.

指标中文名：

自我报告巴氏指数

指标类型：

主要指标

Outcome：

Self-Reported Barthel Index (SRBI)

Type：

Primary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

采用Barthel指数自我报告问卷评估日常生活能力。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Self-reported questionnaire assessment using the Barthel Index.

指标中文名：

迷你平衡评估系统测试

指标类型：

主要指标

Outcome：

Mini-Balance Evaluation Systems Test (Mini-BESTest)

Type：

Primary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

采用Mini-BESTest标准化程序进行动态平衡评估。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Dynamic balance assessment using standardized Mini-BESTest procedures.

指标中文名：

计时起立-行走测试

指标类型：

主要指标

Outcome：

Timed Up and Go Test (TUG)

Type：

Primary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

记录受试者从坐起、行走3米、返回坐下的总时间。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Time required to stand up, walk 3 meters, turn, return, and sit down.

指标中文名：

6分钟步行测试

指标类型：

主要指标

Outcome：

6-Minute Walk Test (6MWT)

Type：

Primary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

标准化6分钟步行测试，记录总步行距离。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Standardized 6-minute walk test, recording total walking distance.

指标中文名：

步速

指标类型：

次要指标

Outcome：

Gait Speed

Type：

Secondary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

步态分析系统，记录平均步速。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Gait analysis system to record average gait speed.

指标中文名：

步长

指标类型：

次要指标

Outcome：

Step Length

Type：

Secondary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

步态分析系统采集，计算平均步长。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Collected via gait analysis system, calculating average step length.

指标中文名：

步时

指标类型：

次要指标

Outcome：

Step Time

Type：

Secondary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

步态分析系统采集，计算平均步时。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Collected via gait analysis system, calculating average step time.

指标中文名：

步速变异系数

指标类型：

次要指标

Outcome：

Coefficient of Variation of Gait Speed

Type：

Secondary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

步态分析系统计算步速变异系数。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Gait analysis system calculating the coefficient of variation for gait speed.

指标中文名：

步长变异系数

指标类型：

次要指标

Outcome：

Coefficient of Variation of Step Length

Type：

Secondary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

步态分析系统计算步长变异系数。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Gait analysis system calculating the coefficient of variation for step length.

指标中文名：

步时变异系数

指标类型：

次要指标

Outcome：

Coefficient of Variation of Step Time

Type：

Secondary indicator

测量时间点：

基线（T0）、干预结束（T1）

测量方法：

步态分析系统计算步时变异系数。

Measure time point of outcome：

Baseline (T0), Post-intervention (T1)

Measure method：

Gait analysis system calculating the coefficient of variation for step time.

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 35 岁 years
最大 Max age 65 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）：

本研究采用分层区组随机化（Stratified Block Randomization）方法将受试者以1:1:1的比例分配至血流限制联合功能训练组（BFR+Func）、单纯功能训练组（Func）及空白对照组（Control）。随机化过程按疾病严重程度（Hoehn & Yahr分期）进行分层，以控制其对结果的潜在影响。由独立统计人员通过计算机生成随机序列，并采用按序编号、不透光密封信封（SNOSE）的方式进行分配隐藏。分配操作由不参与结局评估的研究助理在基线评估完成后启封执行。为确保结果评估的客观性，本研究实施了评估者盲法，即结局测量人员对受试者的分组信息保持盲态，且与干预实施团队相互独立。

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

This study utilized a stratified block randomization method to allocate participants in a 1:1:1 ratio to one of three groups: the blood flow restriction combined with functional training group (BFR+Func), the functional training alone group (Func), or the control group (Control). The randomization process was stratified by disease severity (Hoehn & Yahr stage) to control for its potential influence on the outcomes. An independent statistician generated the random sequence using computer software, and allocation concealment was achieved using sequentially numbered, opaque, sealed envelopes (SNOSE). The allocation procedure was carried out by a research assistant not involved in outcome assessments; envelopes were opened only after baseline evaluations were completed. To ensure the objectivity of outcome assessments, assessor blinding was implemented, meaning that personnel responsible for measuring outcomes were kept unaware of group assignments and were independent of the intervention team.

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：

由于干预性质，受试者和治疗师无法盲法，但结局评估者全程盲法，并与干预实施隔离。

Blinding：

Due to the nature of the intervention, participants and therapists could not be blinded; however, outcome assessors were blinded throughout and kept separate from intervention delivery.

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

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）：

发表论文

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

Publish a paper

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：

本研究使用自制的纸质病例报告表（CRF）收集所有数据。数据随后被录入由天津体育学院管理的中央电子数据库。

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

All data were collected using paper-based Case Report Forms (CRFs) specifically designed for this trial. Subsequently, data were entered into a centralized electronic database managed by Tianjin University of Sport.

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：

  2025-09-25 15:18:40
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