Rehabilitation With Blood Flow Restriction Training to Enhance Anti-gravity Treadmill Effects in the Treatment of Patients With Knee Osteoarthritis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index
研究概览
简要总结
The aim of this randomized controlled study is to investigate whether the implementation of Blood Flow Restriction, in which the de-loading factor is delivered by the combined progressive de-loaded walking to running activity on an antigravity treadmill (treatment group), is more effective than the same antigravity protocol alone (control group).
Participants will be divided as follows:
Intervention group: anti-gravity treadmill combined with blood flow restriction Control group: anti-gravity treadmill Both groups will also undergo a standardized knee Osteoarthritis management through an aerobic and strength program.
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
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age included between 45 and 80 years old
- •Patients with knee OA diagnosed by a medical doctor with a radiological confirmation
- •Patients able to provide informed consent and follow all the study procedures as indicated by the protocol
- •Informed Consent as documented by signature
排除标准
- •Younger than 44 years old or older than 81 years old included
- •Known drug or alcohol abuse
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
- •Participation in another study with an investigational drug within the 30 days preceding and during the present study
- •Treatment with an injective approach in the previous 3 month
- •Surgical treatment in the previous 12 months.
研究组 & 干预措施
Anti-gravity treadmill
干预措施: Anti-gravity treadmill (Other)
Anti-gravity treadmill + Blood Flow Restriction training
干预措施: Blood flow restriction training + Anti-gravity treadmill (Other)
结局指标
主要结局
Post-operative knee outcome on Western Ontario and McMaster Universities Arthritis Index
时间窗: Change from Baseline to 6 months
Questionnaire at baseline (day 1) and 6 weeks, and at 3, 6 months. The WOMAC questionnaire is composed of 3 sub-scores that evaluate pain (5 questions, 0-20 points), stiffness (2 questions, 0-8 points), and function (17 questions, 0-68 points) and is a validated patient-reported outcome measure (PROM) to evaluate knee osteoarthritis.
次要结局
未报告次要终点