Effects of Blood Flow Restriction Training on Lower Limb Muscle Strength and Atrophy in Patients With Knee Arthropathy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- H-reflex Hmax/Mmax Ratio
研究概览
简要总结
Arthrogenic muscle inhibition (AMI) is the key neurophysiological cause of impeding quadriceps activation following anterior cruciate ligament reconstruction (ACLR). Blood flow restriction training (BFRT) may induce neuroplasticity whereas the neurophysiological responses remain uncertain. In this study, we aimed to explore the effects of constant pressure blood flow restriction training (CP-BFRT) on neurophysiological responses and physical function. Patients will receive the same standardized progressive physical rehabilitation for 2 weeks after the surgery and then start the BRFT or sham BRFT intervention for the following 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Knee arthroscopy;
- •Age 18-60 years;
- •Ability to provide informed consent;
- •Availability for follow-up assessments;
- •Written informed consent.
排除标准
- •Neurological disorders affecting lower extremity function;
- •Vascular disease or coagulopathy;
- •Contralateral knee pathology;
- •Previous knee surgery;
- •inability to comply with rehabilitation protocols;
研究组 & 干预措施
Control group
Participants in CON group with sham BFRT completed 3 sets of 10 repetitions for each exercise with the sham unit set to 20 mmHg. The restriction pressure was based on prior work which shows that 20 mmHg is well below the threshold for either arterial or venous occlusion.
干预措施: Standard postoperative knee rehabilitation with sham BFRT (Other)
Blood flow restriction training group
Progressive BFRT exercises with 60%-80% of arterial occlusion pressure. The BFRT protocol was individualized based on limb circumference and tolerance, with pressure settings determined using the limb occlusion pressure method. For lower extremity training, pressure was set at 60%-80% of arterial occlusion pressure (approximately 140-220 mmHg depending on individual limb characteristics).
干预措施: Blood flow restriction training with 60%-80% occlusion (Other)
结局指标
主要结局
H-reflex Hmax/Mmax Ratio
时间窗: From enrollment to the end of treatment at 12 weeks.
H-reflex is a validated neurophysiological indicator for evaluating spinal-level AMI after knee surgery which is applied to assess resting spinal reflex excitability of the knee extensor motor pool vastus medialis. Unit of Measure: Ratio (dimensionless)
次要结局
- Knee Joint Position Sense (JPS) Accuracy(From enrollment to the end of treatment at 12 weeks.)
- Somatosensory Evoked Potential (SEP) P40 Latency(From enrollment to the end of treatment at 12 weeks.)
- Somatosensory Evoked Potential (SEP) N45-P40 Peak-to-peak Amplitude(From enrollment to the end of treatment at 12 weeks.)
- Quadriceps rapid torque development rate (RTD)(From enrollment to the end of treatment at 12 weeks.)
研究者
Yuxiu Ji
Attending Physician, Department of Rehabilitation Medicine, Principal Investigator
The Affiliated Hospital Of Southwest Medical University