The Acute and Chronic Impact of Blood Flow Restriction Resistance Training on Physical and Neuromuscular Function, Pain, and Quality of Life in Patients With Moderate/Severe Hemophilia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Muscle ultrasound (muscle mass, assessment of possible bleedings)
研究概览
简要总结
The main objectives of this study are to evaluate safety and chronic effects of a low-load resistance exercise intervention (elbow flexions and extensions, and knee extensions) with blood flow restriction in people with hemophilia on quality of life, pain, and on physical and neuromuscular function.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •diagnosis of hemophilia A or B and undergoing prophylaxis;
- •willingness to exercise twice a week during the training program and to complete the pre- and post-program evaluations;
- •approval by their hematologist to participate in the exercise program;
- •age between 18 and 60 years;
- •informed consent signed.
排除标准
- •the inability to attend exercise sessions at least twice a week for 8 consecutive weeks;
- •non adherence to instruction on proper exercise technique;
- •surgical procedures performed 6 weeks prior to or during the exercise program; - participation in any other form of exercise, not previously done, during the study;
- •changes in medication during the study;
- •a major bleeding episode that posed a risk or prevented exercise;
- •another hemostatic defect;
- •need for major surgery;
- •withdrawal of informed consent.
研究组 & 干预措施
Control
The training program for the control group consists of a telerehabilitation with traditional moderate-to-high load (60%-80% 1RM) exercises (the same as the intervention group sans BFR), utilizing elastic bands. This program for the control group will be conducted in an in-home real-time audio and video style and supervised by a physiotherapist.
干预措施: Control (Other)
BFRT
The BFR training program for the intervention group consists of elbow flexion and extension, and knee extension exercises performed with low load (elastic bands; equivalent to 30% 1RM) and concurrent BFR (upper limb 50% AOP; lower limb 60% AOP). Subjects will perform 4 sets (30, 15, 15 and 15 reps) of each exercise with 30 s rest between sets and 5-minute rest between exercises.
干预措施: BFRT (Other)
结局指标
主要结局
Muscle ultrasound (muscle mass, assessment of possible bleedings)
时间窗: Baseline and week 8.
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
HDsEMG
时间窗: Baseline and week 8.
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Hand-held dynamometry (isometric elbow flexion/extension, knee extension)
时间窗: Baseline and week 8.
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
Digital goniometry for active elbow and knee ROM
时间窗: Baseline and week 8.
Change from baseline to the end of the intervention, and the change between the intervention group and the control group.
次要结局
- Haemophilia Activities List (HAL) questionnaire(Baseline and week 8.)
- A36 haemophilia quality of life (Hemofilia-QoL) questionnaire(Baseline and week 8.)
- Patient Global Impression of Change Scale (PGICS)(Baseline and week 8.)
- Pressure pain thresholds (digital algometry)(Baseline and week 8.)
- Self-reported pain intensity (Visual Analogue Scale (VAS) Scale 0-10)(Baseline and week 8.)
研究者
Sofia Perez-Alenda
Dean of Faculty of Physiotherapy
University of Valencia