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
- 终止
- 入组人数
- 56
- 试验地点
- 1
- 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.
研究组 & 干预措施
home-based BFRE
Patients in the home-based BFRE group will be carefully instructed in how to perform the exercise program with four weekly sessions for 12 weeks (48 training sessions within an 84-day period). Each session will consist of one lower-limb resistance training exercise: sit-to-stand from a ~43 cm high chair. The exercise will consist of four rounds interspaced by a 30-seconds rest pause. The first, second, and third round will consist of 30, 15, 15 repetitions, while the fourth round will be performed until volitional fatigue. The patients will be instructed to perform both the eccentric and concentric contractions at a steady 2-sec pace with, preferably, no time for relaxation in the transition from eccentric to concentric phase (i.e. the bottom is only "kissing" the chair before reversing the movement upwards). When a patient can perform more than 25 repetitions in the last round, they are encouraged to add external resistance corresponding to around 5 kg.
干预措施: Blood flow restricted low-load resistance exercise (Other)
Control Group
Patients in the control group will performed the same tests 12 months after surgery and 15 months after surgery as the intervention home-based BFRE group.
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)
- Timed Up & Go (TUG)(15 months after surgery)
- Isometric knee extensor strength(15 months after surgery)
- Isometric knee flexor strength(15 months after surgery)
- Adverse events(15 months after surgery)
- Timed Up & Go (TUG)(1 yeay after surgery)
- 4x10 meter fast-paced walk test (40m-FWT)(1 year after surgery)
- Numeric Rating Scale Pain (NRS pain)(15 months after surgery)
- Isometric knee extensor strength(1 year after surgery)
- Isometric knee flexor strength(1 year after surgerty)
- Knee disability and Osteoarthritis Outcome Score (KOOS)(1 year after surgery)
- EuroQol Group 5-dimension (EQ-5D-5L)after surgery(1 year after surgery)
- Numeric Rating Scale Pain (NRS pain)(1 year after surgery)