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

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04600661
• Other study ID #: 012/002777
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: September 15, 2021

Study information

• Verified date: June 2020
• Source: Cairo University
• Contact: Mai M Abdelkader
• Phone: +201094355573
• Email: mai.abdelkader[@]pua.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: September 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• Traditional exercise therapy
Neuromuscular training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mai Mohamed Abdelkader Abdallah

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle strength	Hand-Held Dynamometer for measuring muscle strength	3 months
Secondary	Knee joint function	Western Ontario and McMaster Universities osteoarthritis index for an Arab population for assessing knee function	3 months