Rehabilitation With Blood Flow Restriction Training to Enhance Anti-gravity Treadmill Effects in the Treatment of Patients With Knee Osteoarthritis: a Randomized Controlled Trial
概览
- 阶段
- 不适用
- 干预措施
- Anti-gravity treadmill
- 疾病 / 适应症
- Knee Osteoarthritis
- 发起方
- Ente Ospedaliero Cantonale, Bellinzona
- 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
- 状态
- 进行中（未招募）
- 最后更新
- 上个月
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.
研究者
入排标准
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
Anti-gravity treadmill + Blood Flow Restriction training
干预措施: Blood flow restriction training + Anti-gravity treadmill
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.