Effects of Low-load Resistance Training With Blood Flow Restriction in Patients With Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Change on pain intensity
研究概览
简要总结
Midportion Achilles tendinopathy (MAT) is a common overuse injury of the lower extremity characterized by the presence of pain, restricted function and interruption of sport activities. Conservative management of MAT has been suggested as the first line of treatment. Actually, there are several exercise programs with beneficial effects on pain and function among which high load training stands out. However, this training modality is inherently difficult to implement in certain populations and pathological conditions due to their inability to tolerate this mechanical stress. In this sense, low load training with blood flow restriction (BFR-LLT) emerges as an effective option in producing hypertrophic adaptations with low intensities (30% 1RM). However, this training modality has not yet been studied in tendon pathology. The aim of this study is to evaluate the potential clinical effects of BFR-LLT in comparison with HLT in patients with chronic MAT.
详细描述
The aim of this study will be to evaluate the potential clinical effects of low load training with blood flow restriction (BFR-LLT) in comparison with high load training (HLT) in patients with chronic midportion Achilles tendinopathy (MAT). The secondary objectives will be to determine if there are differences in the neovascularity and thickness, pain and function of the AT between both groups in each instance of evaluation. This study will be a simple-blinded randomized clinical trial comprising a total sample size of 52 participants with MAT of both genders and aged between 18 and 50 years. Subjects will undergo a screening process by a sports medicine doctor by different diagnostic tests to identify those presenting a diagnosis of painful MAT and then, they will be randomized into either a group performing HLT (G1), or a group performing BFR-LLT (G2). These volunteers will be recruited in the Parque Hospital (Rosario, Argentine). The study will assess the subjects tendon pain, thickness, cross sectional area and neovascularity, lower limb function, calf raise endurance and jump height. The training protocol will be performed in the University of Gran Rosario (Rosario, Argentine) and will consist of three weekly training sessions during a 12-week rehabilitation period. Primary and secondary outcomes will be measured at baseline, 6 and 12 weeks. All the evaluations will be performed by a blinded physiotherapist.
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)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of unilateral MAT.
- •Achilles pain > 3 months.
- •Age ranging between 18 to 50 years, both genders.
- •Read and speak Spanish well enough to provide informed consent and follow study instructions.
- •Can attend in-clinic treatments 2-3 x weekly for the next 12 weeks.
排除标准
- •Any ankle or foot surgery.
- •History of Achilles rupture.
- •Heel pain in the last 3 months.
- •Systemic disorders/diseases.
- •History of deep venous thrombosis, hypertension or blood clotting disorder.
- •Body mass index > 30kg/m
- •Self-report of pregnancy.
- •Drug use (local steroid injection or systemic fluoroquinolones).
- •Pain < 2/10 of average pain on NPRS.
- •VISA A score > 90%.
- •Unable to perform any of the exercises of the study.
结局指标
主要结局
Change on pain intensity
时间窗: At baseline, then at 6 and 12 weeks
The Numerical Pain Rating Scale (NPRS) will be used to assess pain intensity in daily and sport activities. This scale consists of a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Change on Victorian Institute of Sport Assessment- Achilles Specific Questionnaire (VISA-A)
时间窗: At baseline, then at 6 and 12 weeks
This questionnaire will be used to assess the symptoms, function and pain during daily living and sport activities. The VISA-A consists of 8 questions in which the patients rate the magnitude of pain during rest, function, and activity. The maximum score is 100 points, and a lower score indicates more symptoms and a greater limitation of function and activity.
次要结局
- Change on neovascularization of the Achilles tendon(At baseline and 12 weeks)
- Change on single leg vertical jump(At baseline, then at 6 and 12 weeks)
- Change on single leg calf-raise endurance test(At baseline, then at 6 and 12 weeks)
- Change on thickness of the Achilles tendon(At baseline and 12 weeks)
- Change on cross sectional area of the Achilles tendon(At baseline and 12 weeks)
研究者
Gonzalo Elias
Physiotherapist
University of Gran Rosario