Effects of Blood Flow Restriction Training With Low Intensity Exercises in Knee Osteoarthritis

Not Applicable

Recruiting

• Conditions: Knee Osteoarthritis
• Interventions: Other: blood flow restriction training; Other: ultrasound therapy

• Registration Number: NCT06502587
• Lead Sponsor: Riphah International University

Brief Summary

The aim of the study is to examine the effects of blood flow restriction training(BFRT) with low intensity exercises on pain, range of motion and quality of life in Knee Osteoarthritis. A randomized clinical trial will be conducted at Lahore general hospital. Non-probability convenience sampling will be used, and 36 subjects, age 40-65 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria.

Detailed Description

The aim of the study is to examine the effects of blood flow restriction training(BFRT) with low intensity exercises on pain, range of motion and quality of life in Knee Osteoarthritis. A randomized clinical trial will be conducted at Lahore general hospital. Non-probability convenience sampling will be used, and 36 subjects, age 40-65 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria. Both groups will receive Ultrasound therapy for 7 minutes, as common treatment. Group A will be treated with Blood flow restriction training with low intensity exercises and Group B will be treated with baseline treatment only. 3 sessions per week and total 12 sessions for 4 weeks. The outcome measures will be conducted through NPRS, Womac index for osteoarthritis,kellgren and lawrence scale and goniometry before and after 4 weeks. Data will be analyzed using SPSS software version 26.

Study Timeline

• Study Start: 2023-11-23
• Study First Submitted: 2024-06-11
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-15
• Last Update Submitted: 2024-07-15
• Study First Posted: 2024-07-16
• Last Update Posted: 2024-07-16
• Primary Completion: 2024-07-20
• Study Completion: 2024-07-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Both Male and Female age between 40 to 65 years diagnosed with womac ostearthritis index having acute knee pain.
• Patients with history of osteoarthritis (of grade 1 and 2 with KL(kellgren and Lawerence)) grading system for knee Osteoarthritis
• Pain in and around knee measuring through Numeric Pain rating Scale(NPRS)>4(14)

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Exclusion Criteria

Patient with history of

• hypertension
• diabetes
• sickle cell anemia
• renal compromise
• obesity
• open fracture,
• increased intracranial pressure
• pregnancy
• cancer or tumor,
• extremity with dialysis access,
• extremity fracture
• peripheral vascular compromise
• DVT(Deep vein thrombosis) & pulmonary embolism deformity of hip & back

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
blood flow restriction training	blood flow restriction training	we will apply blood flow restriction training with low intensity exercises on patients with knee osteoarthritis to check pain,quality of life and range of motion.
ultrasound application only	ultrasound therapy	in this group we will apply ultrasound therapy on knee joint for 7 minutes.

Primary Outcome Measures

Name	Time	Method
NPRS Numeric pain rating scale	4th week	The NPRS is a self-reported, or clinician administered, measurement tool consisting of a numerical point scale with extreme anchors of 'no pain' to 'extreme pain'. The scale is typically set up on a horizontal or vertical line, ranges most commonly from 0-10 or 0-100, and can be administered in written or verbal form. The patient is asked to rate his/her pain intensity and a particular time frame or descriptor is established (e.g. within the last 24 h, today, worst pain, average pain, or least pain)

Secondary Outcome Measures

Name	Time	Method
Womac index for knee osteoarthritis	4th week	WOMAC measures three separate dimensions: Pain (5 questions), Stiffness (2 questions), and Pain, stiffness, and physical function were measured by WOMAC. This instrument is validated and recommended by the Osteoarthritis Research Society as the measure of choice when assessing health status in older adults with knee OA. Rating scale ranges from 0 (none) to 4 (extreme), with higher total scores indicating greater dysfunction.The WOMAC addresses symptoms and functional disability in separate scales . Also, the WOMAC is a patient questionnaire.
Universal goniometer	4th week	The most common tool for measuring ROM has been the universal goniometer (UG; full-circle manual goniometer. The advantage with the UG is its low cost, but both hands are needed to perform the measurements
Knee Related QOL (QUALITY OF LIFE) Subscale From KOOS	4th week	The Knee injury and Osteoarthritis Outcome Score (KOOS) was developed as an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with knee injury and osteoarthritis The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). The effect size is generally largest for the subscale QOL followed by the subscale Pain. The KOOS is a valid, reliable and responsive self-administered instrument that can be used for short-term and long-term follow-up of several types of knee injury including osteoarthritis

Trial Locations

Locations (1)

Lahore General Hospital; 🇵🇰 Lahore, Punjab, Pakistan