The Effect of Low-Load Resistance Training With Blood Flow Restriction for Treatment of Chronic Patellar Tendinopathy - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Change from baseline - 12 weeks using the clinical functional test Single-Leg Decline Squat measured on the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
研究概览
简要总结
The purpose of this study is to investigate the clinical and functional outcome of a 12-week rehabilitation regime consisting of Low-Load Blood Flow Restriction compared to Heavy-Slow Resistance training in male patients with chronic unilateral patellar tendinopathy.
详细描述
Chronic tendinopathy represents a considerable problem in both elite and recreational athletes, and symptoms may affect athletic performance and reduce or even result in retirement from sports participation. The current best treatment is considered to be heavy-slow resistance training (HSRT); however, not all patients are able to cope with heavy exercise loads. Therefore, low-load strength training performed under partial blood flow restriction may be a clinically relevant rehabilitation tool.
This project aims to investigate a new innovative intervention to treat chronic unilateral patellar tendinopathy in male individuals using strength training with low-load muscle contractions performed under partial blood flow restriction (LL-BFR), and to compare the resulting treatment outcome to that of the current best practice (HSRT). Specifically, the effect of LL-BFR will be investigated using a randomized controlled trial design with two groups; 1) a low-load blood flow restriction training program, and 2) a heavy-load slow strength training program. A total sample size of 36 participants are needed when assuming a 10 % dropout.
The training protocol consist of three weekly training sessions during a 12-week rehabilitation period. The primary outcome is measured using the Single-Leg Decline Squat at 12-week.
If LL-BFR proves to be an effective treatment strategy for tendinopathy, it can easily be implemented in daily clinical practice.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessor will be blinded to intervention allocation
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Unilateral patellar tendinopathy
- •Chronic (symptoms >3 months)
- •Pain of ≥ 4 during preferred sporting activity on the numerical pain rating scale (NRS; with 0 being no pain and 10 being the worst imaginable pain)
- •Ultrasonographical tendon swelling
- •Ultrasonographical hypo-echoic area with doppler
排除标准
- •Bilateral tendinopathy
- •Cardiovascular diseases
- •Previous surgery or trauma to the knee joint with an effect on the presenting clinical condition
- •Participants must not have been enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous three months
- •Previous corticosteroid injection for patellar tendinopathy
研究组 & 干预措施
Heavy-Slow Resistance training
Heavy-Slow Resistance training. Three times weekly for 12 weeks.
干预措施: Heavy-Slow Resistance training (Other)
Low-Load Blood Flow Restriction training
Low-Load Blood Flow Restriction training. Three times weekly for 12 weeks
干预措施: Low-Load Blood Flow Restriction training (Other)
结局指标
主要结局
Change from baseline - 12 weeks using the clinical functional test Single-Leg Decline Squat measured on the Numerical Rating Scale (NRS; 0= no pain, 10 = worst imaginable pain)
时间窗: Baseline-12 weeks.
Single-Leg Decline Squat is a reliable patellar tendon pain provocation test used to assess pain during function.
次要结局
- Single-Leg Decline Squat test(Baseline, 3, 6 weeks + 1 year follow-up)
- Pain rating on Numeric Rating Scale (NRS; 0 = no pain; 10 = worst imaginable pain) during training.(Baseline, 3, 6 and 12 weeks + 1 year follow-up)
- Self-reported activity level of sporting activities (hours/week)(Baseline, 3, 6 and 12 weeks + 1 year follow-up)
- Doppler activity using Ultrasonography power Doppler(Baseline, 3, 6 and 12 weeks + 1 year follow-up)
- Tendon thickness measured using Ultrasonography(Baseline, 3, 6 and 12 weeks + 1 year follow-up)
- Muscle cross-sectional area measured using Ultrasonography(Baseline, 3, 6 and 12 weeks + 1 year follow-up)
- Muscle structure measured by MRI(Baseline and 12 weeks)
- Tendon dimensions measured by MRI(Baseline and 12 weeks)
- Isometric Muscle Strength(Baseline, 3, 6 and 12 weeks + 1 year follow-up)
- Pain Pressure Threshold(Baseline, 3, 6 and 12 weeks + 1 year follow-up)
- Adverse events(Baseline-12 weeks + 1 year follow-up)
- Victorian Institute of Sports Assessment - Patellar Tendinopathy(Baseline, 3, 6 and 12 weeks + 1 year follow-up)
研究者
Mikkel Holm Hjortshøj Jensen
Principal Investigator
Bispebjerg Hospital