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

NCT04600661 | Unknown

• 1 other identifier: 012/002777
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Osteoarthritis of the Knee

Keywords

Blood flow restriction training

Outcome Measures

Primary Outcomes (1)

• Muscle strength

  Hand-Held Dynamometer for measuring muscle strength

  3 months

Secondary Outcomes (1)

• Knee joint function

  3 months

Study Arms (3)

control group (Traditional therapy group)

EXPERIMENTAL

control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training

Other: Traditional exercise therapy

Experimental group I (BFR training group)

EXPERIMENTAL

Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR.

Other: Traditional exercise therapy

Experimental group II (Neuromuscular training group)

EXPERIMENTAL

Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises

Other: Traditional exercise therapy

Interventions

Traditional exercise therapy OTHER

Neuromuscular training

Also known as: Blood flow restriction training

Experimental group I (BFR training group); Experimental group II (Neuromuscular training group); control group (Traditional therapy group)

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mai Mohamed Abdelkader Abdallah: lead

Related 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.

  PMID: 26971109 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Mai M Abdelkader

CONTACT

+201094355573; mai.abdelkader@pua.edu.eg

Enas Fawzy, Prof

CONTACT

+2 01127867507; Enas.fawzy@pt.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups using opaque, sealed envelopes, each containing the name of one of the groups. Each patient will sign an informed consent before starting the study (Appendix III). All patients will be referred by the orthopedic surgeon who will diagnose knee OA based on clinical and radiological examination. The investigator will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Masters

Model Details: Sixty Three patients of both genders with mild to moderate unilateral tibiofemoral OA, with age range from 45-60 years will be randomly assigned to 1 of 3 groups control group (Traditional therapy group) (n=21): patients will receive traditional training exercises (high load resistance training) Experimental group I (BFR training group) (n=21): patients will receive LLRT with BFR. Experimental group II (Neuromuscular training group) (n=21): patients will receive neuromuscular training exercises

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: January 15, 2021
• Primary Completion: June 15, 2021
• Study Completion: September 15, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-06