The Effectiveness of Late-initiated Blood Flow Restricted Rehabilitation Exercises on Functional Capacity, Lower Limb Muscle Strength and Patient-reported Outcomes After Total Knee Replacement
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Change in 30-seconds chair stand test (30-CST)
研究概览
简要总结
This trial will investigate the effectiveness of applying low-load blood flow restricted exercise 12 months after receiving a total knee replacement to achieve a functional capacity-level similar to healthy peers. Participants will be allocated to either an exercise group performing a sit-to-stand exercise 4/weekly with concurrent partial restriction of the blood flow to the limbs or a usual care.
详细描述
Blood flow restricted exercise (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 group: After being introduced to the exercise principles, the participants will perform 4/weekly home-based BFRE sessions for 12 weeks from. Each session will consist of a sit-to-stand exercise performed with concurrent partial restriction of the blood flow to the limbs. The exercise 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. 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, more external resistance will added at the next session.
Group 2:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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 included in the EXknee project (Efficacy of low-load blood flow restricted resistance EXercise in patients with Knee osteoarthritis scheduled for total knee replacement (EXKnee) Jorgensen et al. 2020)
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
- •Cancer diagnosis and currently undergoing chemo-, immuno-, or radiotherapy
- •Inadequacy in written and spoken Danish
- •living more than 45 minutes from either Horsens Regional Hospital or Silkeborg Regional Hospital.
结局指标
主要结局
Change in 30-seconds chair stand test (30-CST)
时间窗: 15 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
30-seconds chair stand test (30-CST)
时间窗: 1 year 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
- Knee disability and Osteoarthritis Outcome Score (KOOS)(15 months after surgery)
- EuroQol Group 5-dimension (EQ-5D-5L)after surgery(15 months after surgery)
- Numeric Rating Scale Pain (NRS pain)(during 12 weeks exercise program)
- 4x10 meter fast-paced walk test (40m-FWT)(15 months after surgery)
- Exercise compliance and progression(15 months after surgery)
- Isometric knee flexor strength(15 months after surgery)
- Adverse events(15 months after surgery)
- Timed Up & Go (TUG)(15 months after surgery)
- Isometric knee extensor strength(15 months after surgery)