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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:
All participants will receive:
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.
Although the advantages of BFRT in musculoskeletal rehabilitation that reported in the literature, there are conflicting results compared to traditional exercises, as the different protocols parameters, exercises, high risk of bias across previous studies contribute to different conclusions.
Consequently, it raises the question if BFR without exercises can be effective in comparison with traditional exercises that focus on having an efficient intensity to produce muscle strength gain.
Yet, up to authors knowledge, no study has assessed whether BFR at rest could also promote similar gains in muscle strength for the knee OA treatment, which theoretically would increase patient's adherence to KOA treatment based on conclusions of systemic review of BFR without exercises for immobilized patients after orthopedic surgery (Cerqueira et al., 2019).
Another relevant issue is the proper blood flow restriction level for optimal results. Thus, pushes the need for determining a pressure load with the least adverse effects.
Therefore, the main purpose of this study is to assess different protocols of BFR without additional exercises compared to MI-RT for pain reduction in patients with KOA. The secondary purpose is to compare two load levels (70% vs 50%) of BFRT regarding pain, quadriceps muscle strength, rate of perceived exertion, self reported physical function, and functional ability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50% Blood Flow Restriction Group | Experimental | 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. |
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| 70% Blood Flow Restriction Group | Experimental | 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. |
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| Moderate Intensity Exercise training Group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Therapy Device | Device | Blood Flow Restriction (BFR) therapy involves units use standardized cuffs of varying widths and lengths which are physically attached to the devices and provide the capability of precisely controlling the amount of pressure applied to each limb during exercise or at rest. We will be using Smart Cuffs® 4.0 which allows for a fast, hassle-free personalized pressure calculation. With the built-in pressure sensor and on-board computer, it will calculate and set the optimal pressure for each participant's limb. There is no need for an external doppler probe or hand pump. Made in the USA, SmartCuffs® are registered with the FDA as a Class 1 Medical Device. Blood flow restriction therapy is commonly paired with resistive training, so this study will explore the effect of blood flow restriction at rest for patients with osteoarthritis at different restriction levels (50% for first group and 70% for second group). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain intensity | Measured by the Visual Analog Scale (VAS)which is a pain intensity assessment tool.
The closer the mark to zero is better. | Measured 3 times at basline, 4 weeks and 8 weeks |
| Measure change in quadriceps muscle strength | Hand-held dynamometer (HHD) will be used to measure the strength in quadriceps muscle.
| Measured 3 times at baseline, 4 weeks and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in functional ability | Measured by Timed Up and Go Test (TUG) to assess participants' mobility, balance, and functional performance.
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lecturer | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CairoU | Cairo | Giza Governorate | 12611 | Egypt |
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| 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine. | Device | Patients assigned to group will receive strengthening of the lower limb musculature through moderate intensity resistance training (60% of 1RM) using a 45° leg-press machine, 90°-0° of knee flexion knee extension machine, leg curl machine and calf raise machine. |
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| Measured 3 times at baseline, 4 weeks and 8 weeks |
| Change in physical function levels | Measured by Arabic version of Western Ontario McMaster Universities Osteoarthritis Index for Knee Function (ArWOMAC). The WOMAC questionnaire will be handed out to the participants. They will be informed that it consists of a series of questions related to their knee symptoms and how these symptoms affect their daily activities. WOMAC is assigned a numerical score of 0-4 corresponding to severity (none, mild, moderate, severe, and extreme). The minimum score is 0, and the maximum score is 96 (20 points for pain, 8 points for joint stiffness, and 68 points for physical function). The lower the score the better. | Measured 3 times at baseline, 4 weeks and 8 weeks |
| Change in Rate of perceived exertion scale (RPE) | Measured by Arabic version of Omnibus Resistance Exercise 0-10 (OMNI-RES) as a scale for measuring an individual's effort and exertion, breathlessness and fatigue during physical work.
| Measured 3 times at basline , 4 weeks and 8 weeks |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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