- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07402408
Blood Flow Restriction Training in Knee Osteoarthritic Patients
Comparison of Band Tissue Flossing Method and Traditional Cuff Method for Blood Flow Restriction Training in Patients With Knee Osteoarthritis
Study Overview
Status
Conditions
Detailed Description
Osteoarthritis (OA) is a degenerative disorder affecting 528 million people worldwide. It occurs in individuals of age 40 years and above. Most affected joint is knee with prevalence of 60%-85% of total OA cases being 1.39 times higher in women than men. It is characterized by progressive damage to articular cartilage, leading to pain, stiffness, and reduced mobility negatively impacting function and quality of life of affected patients.
Obesity, low level of physical activity, joint overload, muscle imbalance in the knee joint, reduced weight and muscle strength in the lower limbs are the factors which can be modified. Quadriceps strengthening is considered as a first-line therapy making resistance training a common practice in OA management.
A useful alternative to high intensity exercises which are not tolerable by osteoarthritic patients is blood flow restriction (BFR) training. In BFR a cuff is applied around the proximal aspect of the affected limb, causing partial arterial and full venous occlusion, thereby inducing localized hypoxia and the accumulation of metabolites, imitating the effects of high load resistance training without using heavy load and higher repetition. BFR reduces pain along with improving muscle strength, and function in patients with osteoarthritis (OA) and rheumatoid arthritis.
The tissue flossing technique is also called BFR or Kaatsu training. The use of tissue flossing (TF) is a relatively recent treatment modality that gained popularity through the book by Starrett and Cordoza. The mechanisms involved in TF are similar to ischemic preconditioning or BFR training in which an application of an external pressure is used, above or below the muscle or joint, with the application of a tourniquet/inflatable cuff in the most proximal portion of the limb in the case of BFR or an elastic band. Tissue flossing can improve the range of motion or performance, speed up recovery, and decrease the pain caused by various diseases or injuries. The intervention consists of wrapping tissue flossing band around a body region (joint or soft-tissue) using a 50% overlapping in circumferential pattern (distal to proximal), with a relative stretch ranging from 50-75% of the band maximal length, and a treatment duration ranging from 2 minutes to 6 minutes or exercise repetition range from 10 to 30 repetitions.
In 2015, research evaluated effects of BFR on older women and concluded that addition of BFR with resistance training significantly increased leg press or quadriceps strength in older women.
In 2018, a study included forty-eight women with knee OA who were randomized into three groups: low intensity training with BFRT, low intensity training with partial BFRT, and high-intensity resistance training. BFRT and HI-RT were similarly effective in increasing muscle strength, quadriceps muscle mass, and functionality in knee OA patients. Importantly, BFRT was also able to improve pain while inducing less joint stress, emerging as a feasible and effective therapeutic adjuvant in OA management In 2023, study concluded that Low-intensity resistance training with and without blood flow restriction was similarly effective in enhancing functional status in subjects with knee osteoarthritis. A pilot study performed in 2024 on older adults with knee OA shows that (BFR) significantly reduced pain. In the timed up and go and sit to stand tests, completion times were significantly reduced. Thigh and calf circumferences, as well as thigh muscle thickness significantly increased after exercise. However, isokinetic knee strength did not show significant changes. RCT performed in 2024 investigated the long-term effects of BFRT in patients with knee OA and concluded that BFRT is a promising tool to optimize patient outcomes in the rehabilitation of KOA in the long term.
A study in 2021 concluded that compared to the control condition, the flossing treatment showed a positive effect on the maximum voluntary contraction of the knee extensors .
Another study in 2020 states, flossing yielded greater improvements in the passive knee extension test and yielded significant improvements in the maximal eccentric knee extension contraction than dynamic stretching flossing on hamstring muscles is more beneficial than dynamic stretching with respect to increasing ROM and muscle exertion.
A study in 2021 concluded that floss band intervention can significantly improve the flexibility of the quadriceps and hamstrings, quadriceps muscle force output, and dynamic balance without impeding knee proprioception.
According to another study in 2020, flossing bands caused a reduction in perceived knee pain and improved vertical jump performance in young male recreational athlete.
A study in 2022 compared flossing and pneumatic cuff for evaluating their hemodynamic responses to blood flow restriction in healthy population. They concluded that floss band can cause blood flow restriction similar to pneumatic cuff. Clinical application of floss band in KOA population remains underexplored.
To date, no randomized controlled trial has directly compared therapeutic effects of these two BFR interventions in knee OA patients creating a gap in literature. Therefore, the significance of this study lies in its potential to explore the clinical effectiveness of both methods. By doing so, the findings might help inform future research or clinical protocols regarding the use of practical BFR methods in knee OA rehabilitation.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Imran Amjad, Phd
- Phone Number: 03324390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
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Federal
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Islamabad, Federal, Pakistan, 44000
- Pakistan Institute of Medical Sciences (P.I.M.S.)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 40-60 years
- Pain more than or equal to 3 on NPRS
- Range of motion ≤ 100-degree flexion and ≤ 0-degree extension
- Those who have knee osteoarthritis, according to KL (Grade 1 and 2)
- Genders: Male and Female
Exclusion Criteria:
- Cardiovascular condition e.g., hypertension, thromboembolism, lymphatic diseases etc.
- Muscle/tendon/ ligament injuries
- Any surgery, skin infection, trauma, pregnancy, fracture and fall
- Patient with intra articular steroidal therapy with in last 6 months
- Patient unwilling to participate and comply with the study session
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blood flow restriction with Floss band (group A)
seated knee extension and knee press while floss band is tied at proximal thigh.
|
seated knee extension exercise and knee press exercises (4 sets; repetitions: 30,15,15,15) performed for four weeks with three sessions per week.
Exercises performed with 20% of one repetition maximum.
Floss band was tied at proximal thigh with 50% stretch in proximal to distal direction starting from above the patella and moving towards groin.
|
|
Experimental: Blood flow restriction with pneumatic cuff (group B)
seated knee extension and knee press exercises with pneumatic cuff tied at proximal thigh
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seated knee extension exercises and knee press exercises (4 sets; repetitions: 30,15,15,15) performed for four weeks with three sessions per week.
Exercises performed with 20% of one repetition maximum.
Clinical cuff was tied at proximal thigh with 40% of limb occlusion pressure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale (NPRS)
Time Frame: 4th week
|
Changes from baseline will be assessed using NPRS scale.
It is a one-dimensional measure of pain severity in adults including those suffering from chronic pain.
Scale has ratings of 0 to 10, with higher points indicating higher levels of pain severity.
it is a valid tool for assessing pain in knee OA patients.
|
4th week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Western Ontario and McMaster Universities (WOMAC) index
Time Frame: 4th week
|
WOMAC index was developed in order to fill the need for an outcome instrument that could be responsive to change in OA-related symptoms following a clinical trial.
It includes five questions about pain, two about stiffness, and seventeen on degree of disability of activities of daily living.
total score is converted to percentage.
higher scores mean severe symptoms.
|
4th week
|
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30 Second Sit to Stand Test (STS)
Time Frame: 4th week
|
The 30 Second Sit to Stand Test (STS) is also known as 30 Second Chair Stand Test (30CST), was initially designed for testing leg strength and endurance in older adults.
It is used for adults of 18-64 years, older adults (65 years and above), and people with osteoarthritis.
A person stands up and sits down five times as quickly and safely as possible, with their arms folded across their chest, A longer time indicates weaker leg strength and a greater risk of falls.
It records the number of times a person can sit and stand within 30 seconds
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4th week
|
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Timed Up and Go Test (TUG)
Time Frame: 4th week
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This test is for assessing ambulatory transition in knee OA patients.
For this test participant stands from armed chair, walks with comfortable pace to a line 3 m away, at end point turns, and returns to sitting position in chair.
Participant can't use walking aid during task.
Time is recorded in which task is done.
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4th week
|
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Knee Flexion Range of motion
Time Frame: 4th week
|
Changes in knee flexion range of motion from baseline will be assessed using universal goniometer.
Goniometer is the most common instrument utilized for measuring available range of motion.
Universal Goniometer Comes in two variations one is short arm whereas one is long arm.
The one with short arm is used for smaller joints like the wrist, elbow, or ankle.
On the other hand, long arm goniometers provide greater accuracy for knee and hip joints which have long bones acting as levers
|
4th week
|
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Knee Extension Range of Motion
Time Frame: 4th week
|
Changes from baseline in knee extension range of motion will be assessed with goniometer.
It is the most common instrument utilized for measuring available range of motion.
Universal Goniometer Comes in two variations one is short arm whereas one is long arm.
The one with short arm is used for smaller joints like the wrist, elbow, or ankle.
On the other hand, long arm goniometers provide greater accuracy for knee and hip joints which have long bones acting as levers
|
4th week
|
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Quadriceps strength (dynamometer)
Time Frame: 4th week
|
Quadriceps muscle strength changes from baseline will be assessed using crane scale dynamometer.
Participant sits in chair with hips and knees flexed to 90 degrees.
The hook of dynamometer is secured to the ankle with a strap, while from behind the dynamometer is fixed to leg of chair to provide a stable anchor.
As the participant performs knee extension the force generated is recorded in newtons or kilograms.
It is a valid and reliable tool for assessing strength of knee extensors.
|
4th week
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muhammad Affan Iqbal, PhD*, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah/RCRAHS/REC/MS-PT/02171
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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