Safety and Efficacy of a Physiotherapy Intervention Through Blood Flow Restriction in Improving Muscle Strength in Patients With Hemophilic Knee Arthropathy: Multicenter Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline hemarthrosis after treatment and at four weeks
研究概览
简要总结
Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.
Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.
Study design. Randomized, multicenter, single-blind clinical study. Method. 60 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 6 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and functionality (Timed up and go test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.
Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, functionality, and the perception of quality of life in patients with hemophilic knee and ankle arthropathy.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with hemophilia A and B
- •People with a medical diagnosis of hemophilic knee arthropathy
- •Adults (> 18 years)
- •In prophylactic treatment regimen or on demand with FVIII/FIX concentrates.
- •Failure to sign the informed consent document
排除标准
- •Patients with neurological or cognitive alterations that prevent understanding of the questionnaires
- •Amputee patients, epileptics or patients with severe vision problems
- •Patients who are receiving physiotherapy treatment at the time of the study
研究组 & 干预措施
Experimental group
The intervention will consist of carrying out a physiotherapy protocol, consisting of strength training through blood flow restriction, with an occlusion pressure of 40-50% of the LOP (Limb Occlusion Pressure) and a load of 20-30%. of 1RM performed ad hoc for patients with hemophilic arthropathy.
The intervention protocol will be carried out in person under the supervision of the main researcher. The intervention will last 4 weeks, with a frequency of 3 weekly sessions. In total there will be 12 sessions lasting approximately 30-45 minutes
干预措施: Blood flow restriction (Other)
Control group
The patients included in the control group will not receive any Physiotherapy intervention and will continue with their usual routine, being evaluated in the same periods as the rest of the patients.
结局指标
主要结局
Change from baseline hemarthrosis after treatment and at four weeks
时间窗: Screening visit, within the first seven days after treatment and after four weeks follow-up
self-registration will be used to evaluate the frequency of bleeding, and thus the safety of the technique. This self-registration will be given to each patient at the beginning of the study and they must fill in the number of hemarthrosis and their main characteristics: date, origin (traumatic or spontaneous) and location (knee or ankle). The self-registration will be delivered to the evaluator in each of the study evaluations (post-treatment and follow-up).
次要结局
- Change from baseline pressure pain threshold after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up)
- Change from baseline functionality after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up)
- Change from baseline muscle strength after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up)
- Change from baseline range of motion after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up)
- Change from baseline joint status after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up)
- Change from baseline electrical activity of the muscles after treatment and at four weeks(Screening visit, within the first seven days after treatment and after four weeks follow-up)