The Efficacy of Low-load Blood Flow Restricted Resistance Exercise in Patients With Knee Osteoarthritis Scheduled for Total Knee Arthroplasty: A Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 3
- 主要终点
- 30-seconds chair stand test (30-sec CST)
研究概览
简要总结
The primary aim of this study is to investigate the efficacy of 8 weeks of Low-load blood flow restricted exercise (BFRE) compared to receiving standard care only (no preoperative training) before total knee replacement (TKR) on postoperative 30-seconds chair stand test (30s-CST). We hypothesize that 8 weeks of preoperative BFRE will increase chair stand performance 3 months postoperatively. Secondary aims are to investigate the efficacy of 8 weeks of preoperative BFRE compared to receiving standard care only on changes in muscle strength 3 months after TKR and investigate associations to functional capacity and quality of life. Furthermore, it will be investigated if 8 weeks of BFRE induces muscle hypertrophy and increases satellite cell and myonuclei content of the vastus lateralis muscle.
详细描述
BFRE is resistance training with low loads (30% 1repetition maximum (RM) performed with concurrent partial blood flow restriction by means of pneumatic cuff compression around the working limb.
Group 1 (BFRE):
BFRE group: Will perform 3/weekly supervised BFRE sessions for 8 weeks from a physiotherapist educated in administering BFRE. Each session will consist of a 10-min warm up followed by two different unilateral lower-limb resistance training exercises: leg press and knee extension. Each exercise will be performed with the affected lower limb only and consist of 4 rounds interspaced by 30 seconds of rest. 1st round: 30 repetitions (reps); 2nd round: 15 reps; 3rd round: 15 reps; 4th round: until exhaustion. Between each exercise the patients will rest for 5 minutes without blood flow restriction.
Patients will rest in a standardized resting position between each set to maintain the desired resting cuff-pressure.
The occlusion pressure will be set at 60% of total limb occlusion pressure and starting load intensity will be 30% 1repetition maximum (1RM) in both exercises. If patients can perform more than 15 repetitions in the 4th exercise set, the exercise load will be increased with the minimum extra load possible.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ≥ 50 years scheduled for TKA at Horsens- or Silkeborg Regional Hospital.
排除标准
- •Severe cardiovascular diseases (New York Heart Association class III and IIII), previous stroke incident, thrombosis incident
- •Traumatic nerve injury in affected limb
- •Unregulated hypertension (Systolic ≥180 or diastolic ≥110 mmHg)
- •Spinal cord injury
- •Pregnancy
- •Planned other lower limb surgery within 12 months
- •Cancer diagnosis and currently undergoing chemo-, immuno-, or radiotherapy
- •Inadequacy in written and spoken Danish
- •an existing prosthesis in the index limb
- •living more than 45 minutes from either Horsens Regional Hospital or Silkeborg Regional Hospital.
研究组 & 干预措施
Group 1 (BFRE)
Low-load blood flow restricted exercise 3/weekly for 8 weeks before TKR 10-min warm-up followed by unilateral leg press and unilateral knee extension
干预措施: Low-load blood flow restricted exercise (Other)
Group 2 (CON)
No training before TKR
结局指标
主要结局
30-seconds chair stand test (30-sec CST)
时间窗: change in 30-sec CST from baseline to 3 months after surgery
The 30s-CST measures the number of sit-to-stand repetitions completed within 30 seconds. Patients will be instructed to perform a sit-to-stand movement starting from a seated position (seat height 43 cm without armrests) having the feet placed flat on the floor shoulder width apart, and arms crossed on chest to a standing position (hip and knee joints fully extended) repeated as many times as possible for 30 seconds.
次要结局
- 4x10 meter fast-paced walk test (40m-FWT)(Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery)
- 1RM knee extension strength(Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery)
- 1RM leg press strength(Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery)
- Knee disability and Osteoarthritis Outcome Score (KOOS)(Measured at baseline, in the week of surgery, 6 weeks after surgery, 3 months after surgery, and 12 months after surgery)
- Muscle biopsy sampling and analysis - myofiber morphology (cross sectional area, fiber type composition, myonuclei number) and myogenic stemm cell (satellite cell) content(Measured at baseline, in the week of surgery, and 3 months after surgery)
- Adverse events(3 months after surgery)
- Timed Up & Go(Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery)
- Isometric knee extensor strength(Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery)
- Isometric knee flexor strength(Measured at baseline, in the week of surgery, 3 months after surgery, and 12 months after surgery)
- EuroQol Group 5-dimension (EQ-5D-5L)(Measured at baseline, in the week of surgery, 6 weeks after surgery, 3 months after surgery, and 12 months after surgery)