Blood Flow Restriction With Different Loads Versus Moderate Resistive Exercises in Patients With Knee Osteoarthritis: A Double Blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change in pain intensity
研究概览
简要总结
This clinical trail will be conducted to investigate the effect of blood flow restriction (BFR) with different load levels between low blood occlusion percentage (50%) group and high blood occlusion percentage (70%) compared to moderate intensity training (60% of 1 RM) in patients with chronic knee osteoarthritis.
The main questions it aims to answer are:
- Will there be no difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on pain intensity in knee osteoarthritis ?
- Will there be no difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on quadriceps muscle strength in knee osteoarthritis ?
- Will there be no difference difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on rate of perceived exertion in knee osteoarthritis ?
- Will there be no difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on functional ability in knee osteoarthritis ?
- Will there be no difference between the effect of (70% vs 50%) of BFR versus traditional moderate resistive training exercises on physical function in knee osteoarthritis ?
All participants will receive:
- 16 sessions of supervised intervention 2 times per week for 8 weeks.
- The assessment will be at 3 time points, baseline and at 4 weeks and at 8 weeks.
详细描述
Knee osteoarthritis (KOA) is a prevalent degenerative musculoskeletal condition that primarily causing pain, stiffness, and disability. It is a multifactorial disease influenced by a combination of genetic, biomechanical, and environmental factors Osteoarthritis Research Society International (ORSI) recommended strength training as a possible treatment method to slow progression of knee OA. Strength training, as recommended by the American College of Sports Medicine (ACSM), must be performed at a minimum resistance training load of 60% to 70% 1-repetition maximum (1RM) for strength improvement.
Only 13% of older patients with knee OA satisfactorily can perform moderate to vigorous physical activity.
Unfortunately, risk factors of knee OA (as obesity, knee pain, knee injury/surgery) also contribute to a perceived reduced tolerance to the resistive training programs recommended for eliciting strength gains.
An alternative to traditional strength training that may be well tolerated by patients with Knee OA is Blood flow restriction (BFR) training.
This reduced blood flow creates a unique physiological environment, inducing a state of metabolic stress and cellular hypoxia in the muscles.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with chronic knee osteoarthritis referred by orthopedic surgeons participants of both genders age are 40-
- •Patients with grade 2 and 3 OA of the knee, according to radiologic evaluation
- •If both knees diagnosed as OA, the most affected one will be selected.
- •Diagnosis of Knee OA who had knee pain and functional disabilities for at least three months, according to American College of Rheumatology classification at screening visit.
- •Visual Analogue Scale (VAS) at rest score of ≥40 mm.
- •Arabic version of the western WOMAC (ArWOMAC) scores (average 37).
- •Moderate Physical activity score on the IPAQ (between 3.0 and 7.9 METS).
排除标准
- •Moderate to significant knee synovitis
- •Hot or red knee
- •History and/or physical examination findings compatible with the internal derangement of knee.
- •Knee pain that is initiated or increased with knee activity/exercise and finished or decreased with knee resting.
- •Other muscular, articular, or neurological condition affecting lower limb function.
- •Patients with any previous knee surgeries or fractures of lower limb
- •Patients who had undergone arthroscopy or treatment with intra-articular hyaluronic acid during the previous 6 months.
- •Psychological or psychiatric disorders that may affect a subject's participation in the study.
- •Participants with congenital musculoskeletal lower limb deformity.
- •Participated in other intervention studies on the past 6 months to screening
- •Participants with contraindications to blood flow Restriction Training.
研究组 & 干预措施
50% Blood Flow Restriction Group
The Blood Flow Restriction device will be set to restrict blood flow at level of 50% of arterial occlusion pressure at rest.
Blood Flow Restriction sessions will be 5 sets of 5 mins of occlusion and 3 mins of free flow , 2 sessions per week for eight weeks exercises to assess its effects on knee osteoarthritis-related outcomes.
干预措施: Blood Flow Restriction Therapy Device (Device)
70% Blood Flow Restriction Group
The Blood Flow Restriction device will be set to restrict blood flow at level of 70% of arterial occlusion pressure at rest.
Blood Flow Restriction sessions will be 5 sets of 5 mins of occlusion and 3 mins of free flow , 2 sessions per week for eight weeks exercises to assess its effects on knee osteoarthritis-related outcomes.
干预措施: Blood Flow Restriction Therapy Device (Device)
Moderate Intensity Exercise training Group
Patients assigned to this group will receive strengthening of the lower limb musculature through moderate intensity resistance training (60% of 1RM) for a total of 16 treatment sessions according to exercise guidelines for seniors with OA.
MIRT protocols consists of 3 sets for every exercise, 12 repetitions per set, rest period between sets 2 mins, 2 session per week for 8 weeks.
Resistance exercises will be performed using a 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine.
干预措施: 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine. (Device)
结局指标
主要结局
Change in pain intensity
时间窗: Measured 3 times at basline, 4 weeks and 8 weeks
Measured by the Visual Analog Scale (VAS)which is a pain intensity assessment tool. * Represented with a 10 cm line with 0 indicating no pain and on the other end 10 indicating severe pain. * The patient is asked to move a marker on the line to the position which best describes their pain. * That it will serve as a subjective measure of their current level of knee pain intensity. The closer the mark to zero is better.
Measure change in quadriceps muscle strength
时间窗: Measured 3 times at baseline, 4 weeks and 8 weeks
Hand-held dynamometer (HHD) will be used to measure the strength in quadriceps muscle. * The maximum force or pressure exerted by the quadriceps muscle during the contraction will be recorded. * Typically, this measurement is expressed in kilograms (kg) and then transferred to Newtons (N) * To enhance reliability, 3 trials may be conducted, and average will be taken to obtain a more representative measurement of muscle strength. * The higher the measurement the higher the muscle strength.
次要结局
- Change in functional ability(Measured 3 times at baseline, 4 weeks and 8 weeks)
- Change in physical function levels(Measured 3 times at baseline, 4 weeks and 8 weeks)
- Change in Rate of perceived exertion scale (RPE)(Measured 3 times at basline , 4 weeks and 8 weeks)
研究者
Farah Fouad Gomaa El Gamal
Masters Degree Student in Faculty of Physical Therapy, Cairo University
Cairo University