Isokinetic Exercise Combined With Blood Flow Restriction: High-Load Vs Low-Load Training : A Randomized Controlled Trial in Post-ACL Reconstruction Populations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Muscle Strength
研究概览
简要总结
The goal of this clinical trial is to see which type of strengthening exercise with a tight band (blood flow restriction) helps people recover better after ACL reconstruction. The study includes adults after ACL surgery who are doing physiotherapy to rebuild thigh muscle strength and knee function.
The main questions are:
- Does heavy strengthening with blood flow restriction improve thigh strength, knee function, and daily activities more than light strengthening with blood flow restriction after ACL surgery?
- Can light strengthening with blood flow restriction give similar benefits to heavy strengthening while putting less strain on the knee?
Researchers will compare a heavy-exercise program plus blood flow restriction to a light-exercise program plus blood flow restriction to see which gives better strength and functional improvements.
Participants will:
- Come for supervised physiotherapy sessions and do knee exercises on a machine, using either heavy or light loads while a cuff on the thigh gently squeezes to reduce blood flow.
- Have their leg strength, and knee questionnaires checked several times during the study.
详细描述
This clinical trial is testing two different ways of doing strength training with a tight leg cuff (blood flow restriction) during rehabilitation after ACL reconstruction. The aim is to find out which program helps people rebuild thigh muscle strength and knee function more effectively, while still keeping the knee joint safe after surgery.
Study purpose and questions After ACL reconstruction, many people lose muscle size and strength in the front of the thigh, which can slow down recovery and delay return to sport or full activity. Blood flow restriction training allows people to train with lighter weights but still gain strength and muscle, which may be useful when heavy loads are not yet safe.
The main questions are:
- Does a heavy-load isokinetic exercise program with blood flow restriction improve thigh strength, knee function, and patient-reported outcomes more than a low-load isokinetic program with blood flow restriction?
- Can low-load isokinetic exercise with blood flow restriction provide similar benefits in strength and function, while placing less stress on the healing knee joint? Who will take part The study will include adults who have had ACL reconstruction and are in the strengthening phase of their rehabilitation. Participants will typically be active people, cleared by their surgeon and physiotherapist to start moderate to high resistance training, with no serious heart, blood vessel, or bleeding problems that would make blood flow restriction unsafe.
What happens in the study Participants will be randomly assigned to one of two groups so that each person has an equal chance of being in either group.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For ACLR group:
- •Isolated unilateral ACL reconstruction 8-16 weeks post-surgery with medical clearance for moderate to high resistance training.
- •For control group(healthy population):
- •Healthy adults with no musculoskeletal pathology.
排除标准
- •History of cardiovascular or metabolic diseases
- •Deep vein thrombosis
- •Coagulopathy
- •Hypertension
- •Skin lesions or infections at the site of BFR cuff administration
- •Neuromuscular disorders
- •Non-clearance from the surgeon or physiotherapist or resistance training.
研究组 & 干预措施
ACL Reconstruction Population
干预措施: High Load Isokinetic Training with Blood Flow Restriction (Other)
ACL Reconstruction Population
干预措施: Low Load Isokinetic Training with Blood Flow Restriction (Other)
Healthy Population
干预措施: High Load Isokinetic Training with Blood Flow Restriction (Other)
Healthy Population
干预措施: Low Load Isokinetic Training with Blood Flow Restriction (Other)
结局指标
主要结局
Muscle Strength
时间窗: Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)
Muscle strength will be measured using Biodex System 4 Pro for concentric quadriceps and hamstring strength at 60°/s and eccentric quadriceps at 60°/s. Recorded parameters: peak torque(Nm/kg), total work(J), and average power(W).
Muscle Girth
时间窗: Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6)
Muscle girth will be measured by measuring the mid-thigh circumference using an inch tape at 15cm above the superior border of the patella. The mean of two readings will be recorded
次要结局
- Pain Reduction(Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6))
- Blood Flow(Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6))
- Tolerability and Perception of the Intervention(s)(Outcome measures will be measured at baseline(week 0), mid-intervention(week 3) and post-intervention(week 6))