The Impact of Progressive Resistance Training on Quality of Life in Patients With Haemophilia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Muscle strength
研究概览
简要总结
This study evaluates the clinical impact of a progressive resistance training program in adults patients with haemophilia
详细描述
The training program aims improving muscular strength and endurance in the relevant muscles and joints (knee, elbow, ankle, shoulder and hip) in order to improve the quality of life in the patients.
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 (Investigator, 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 haemophilia A or B
- •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 6 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, including rehabilitation, during the study; (5) changes in medication during the study
- •a major bleeding episode that posed a risk or prevented exercise
- •History of FVIII inhibitor (titer ≥ 0.6 BU [Bethesda unit]) or detectable FVIII inhibitors at screening (titer ≥ 0.4 BU)
- •Another haemostatic defect
- •Need for major surgery
- •Withdrawal of informed consent
研究组 & 干预措施
Training group
Each subject will participate in 2 sessions each week during 8 weeks, with 3 days of difference (rest) between the sessions.
干预措施: Progressive resistance training (Other)
Control group
Usual daily activities
干预措施: Normal daily activities (Other)
结局指标
主要结局
Change in Muscle strength
时间窗: baseline and 8 weeks
For measuring the isometric knee flexion and extension, ankle plantarflexion and dorsiflexion strength and isometric elbow flexion and extension strength, a portable hand-held dynamometer will be used (Nicholas Manual Muscle Tester, Lafayette Instruments, Indiana, USA).
次要结局
- Change in Timed Up and Go(baseline and 8 weeks)
- Change in Haemophilia Quality of life questionnaire (A36 Haemophilia-QoL® )(baseline and 8 weeks)
- Change in Bleedings(daily (during the 8 weeks of intervention))
- Change in viscoelastic properties (rectus femoris)(baseline and 8 weeks)
- Change in sit-to-stand test(baseline and 8 weeks)
- Change in Haemophilia Activities List questionnaire(baseline and 8 weeks)
- Change in The Haemophilia Joint Health Score (HJHS)(baseline and 8 weeks)
- Change in Pain(baseline and 8 weeks)
- Change in Kinesiophobia(baseline and 8 weeks)
- Change in workability index(baseline and 8 weeks)
- Change in analgesics use (days/week)(baseline and 8 weeks)
- Change in Range Of Motion (ROM)(baseline and 8 weeks)
研究者
Felipe Querol Fuentes
Medical doctor, PhD
University of Valencia