LOW LOAD RESISTANCE BLOOD FLOW RESTRICTION TRAINING VERSUS NEUROMUSCULAR TRAINING IN KNEE OSTEOARTHRITIS

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Other: Traditional exercise therapy

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:

1. 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.
2. 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.
3. 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: Interventional
• Enrollment (Anticipated): 63
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

3

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	Other: Traditional exercise therapy; Neuromuscular training; Other Names: Blood flow restriction training
EXPERIMENTAL: Experimental group I (BFR training group); Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.	Other: Traditional exercise therapy; Neuromuscular training; Other Names: Blood flow restriction training
EXPERIMENTAL: Experimental group II (Neuromuscular training group); Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises	Other: Traditional exercise therapy; Neuromuscular training; Other Names: Blood flow restriction training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	Hand-Held Dynamometer for measuring muscle strength	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee joint function	Western Ontario and McMaster Universities osteoarthritis index for an Arab population for assessing knee function	3 months

Collaborators and Investigators

• Sponsor: Mai Mohamed Abdelkader Abdallah

Publications and helpful links

General Publications

• Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, Duarte A Jr, Fukuda TY. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016 May;24(5):1580-6. doi: 10.1007/s00167-016-4064-7. Epub 2016 Mar 12.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 15, 2021
• Primary Completion (ANTICIPATED): June 15, 2021
• Study Completion (ANTICIPATED): September 15, 2021

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Blood flow restriction training
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 012/002777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No