- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600661
LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PURPOSE:
This study will be conducted to compare the effect of BFR with LLRT versus neuromuscular training on quadriceps muscle strength, knee joint function and proprioception accuracy.
BACKGROUND:
Patients with knee OA may have reduction of tolerance of the high-load programs which is recommended for eliciting strength gains (Messier et al., 2013). Thus, for reducing disease risk and enhancing physical function, there is a need for effectively strengthening the quadriceps muscle while limiting pain and adverse joint loading in people with knee OA (Segal et al., 2015). Blood flow restriction (BFR) with low-load resistance training (LLRT) is an alternative to traditional strength training that can be used in knee OA with minimal adverse joint loading that is normally found in traditional strengthening programs(Pope et al., 2013). It is attained through applying pressure externally with a pneumatic cuff or tourniquet. The applied pressure occludes venous outflow while maintaining arterial inflow with intent to promote blood pooling in the capillary beds of the limb muscles distal to the tourniquet (Slysz et al., 2016). Kubota et al., (2008), showed that BFR can be applied during periods of immobilization to decrease disuse muscle atrophy of limbs. Also it can be combined with exercise which enhances muscular development. Resistance exercise appears to provide great muscular gains when combined with BFR (Slysz et al., 2016).
HYPOTHESES:
- There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving quadriceps muscle strength using HHD in patients with unilateral knee OA.
- There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint function on WOMAC questionnaire in patients with unilateral knee OA.
- There will not be a significant difference between traditional training, BFR with LLRT and neuromuscular training on improving knee joint proprioception in patients with unilateral knee OA.
RESEARCH QUESTION:
Does blood flow restriction with low load resistance training and neuromuscular training have a significant effect over traditional rehabilitation protocol (stretching and strengthening for hip and knee muscles) on quadriceps muscle strength, knee joint function and proprioception accuracy in patients with unilateral knee OA?
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age range from 45-60 years (Segal et al., 2015).
- Walk with painful knee OA without assistive devices (Bryk et al., 2016).
- Mild to moderate unilateral OA grade II-III (K/L) (Bryk et al., 2016).
- BMI < 30 kg/m² (not being classified as obese) (Bryk et al., 2016).
- Never participated in resistance training in the 3 months prior to their appointment (Jan et al., 2008)
Exclusion Criteria:
- Severe knee OA (grade IV according to K/L classification).
- Bilateral knee OA.
- Congenital or acquired inflammatory, rheumatic or neurological (systemic or local) diseases involving the knee.
- Repeated treatment with steroids.
- Secondary knee OA.
- Received joint replacement surgery in either Knee or/and hip.
- Cardiovascular and neuromuscular disorders
- Diabetic patients
- Psychiatric disorders.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: control group (Traditional therapy group)
control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training
|
Neuromuscular training
Other Names:
|
|
EXPERIMENTAL: Experimental group I (BFR training group)
Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.
|
Neuromuscular training
Other Names:
|
|
EXPERIMENTAL: Experimental group II (Neuromuscular training group)
Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises
|
Neuromuscular training
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle strength
Time Frame: 3 months
|
Hand-Held Dynamometer for measuring muscle strength
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee joint function
Time Frame: 3 months
|
Western Ontario and McMaster Universities osteoarthritis index for an Arab population for assessing knee function
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/002777
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
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