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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05058794
Other study ID # REC/00947 Farah Anwar
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 10, 2021
Est. completion date February 11, 2022

Study information

Verified date March 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of the study is to compare the effects of Blood flow Restriction training vs. traditional exercises on knee pain , knee functional disability and on quadriceps strength in patient with knee osteoarthritis.


Description:

Osteoarthritis is a degenerative disease affecting the most commonly weight bearing joint.The common form of arthritis is osteoarthritis (OA) causing structural changes in the joint. Age is a common factor affecting the strength and muscle mass.Worldwide there is a drastic increase of osteoarthritis in the older population. In the past 20 years the prevalence of knee pain increased and reached up to 50% in the older population. The most common OA affecting lower extremity is in the knee Joint.Majority of the people affected by knee OA are the older population. Knee Joints being the most weight bearing joint affected in OA causing pain , limiting function and mobility.Mobility and function may be affected in osteoarthritic population usually experience pain and stiffness. The main objective of this study is to compare the Effects of blood Flow restriction training vs conventional treatment exercises on knee pain, functional disability and quadriceps strengthening. The main purpose of this study is to improve the muscular strength of lower limbs which are being affected in a disease osteoarthritis in the adult population.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date February 11, 2022
Est. primary completion date February 11, 2022
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Pain : Subjects having unilateral or bilateral pain - Pain type : subjects having chronic pain - Includes diagnosed cases of knee osteoarthritis - grades 2-3 according to the Kellgren and Lawrence method of grading - Includes knee osteoarthritis patients with lateral tracking of patella which will assessed through Q angle test Exclusion Criteria: - Any other orthopaedic or neurological condition of hip and knee - Sign and symptoms of lower motor neuron disease - Current use of medication - Radiculopathy - Fracture - Malignancy - Thromboembolism - Decreased range of motion

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood flow Restriction/Resistance Training
During each exercise, only blood flow in the involved leg was restricted using an aneroid sphygmomanometer. Prior to exercise the cuff was placed on the most proximal portion of the limb and limb occlusion pressure (LOP) was calculated in the body position that the Blood flow Restriction (BFR) stimulus would be applied. Blood Flow Restriction BFR pressure was set at 50% occlusion. Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally. Participants will perform exercises 2 sets with 15 repetitions through 0 to 90 degrees.
Conventional Therapy Group
Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally.participants will perform 2 sets with 15 repetitions in (0 to 90 degree.)

Locations

Country Name City State
Pakistan Gulberg Medical Complex Islamabad Federal
Pakistan Medcity International Hospital Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle strength Measurement of Quadriceps strength with portable weight machine. 6 weeks
Primary Thigh Girth Participants will be supine lying and knee in extension, standing or knee at 90 degree. Proximal to the patellar pole superiorly one measurement with a non-elastic tape at the inguinal fold, then mark the mid-point at the mid-thigh level measuring in centimeters/inches. 6 weeks
Primary Numeric Pain Rating Scale ( NPRS) Patient will be asked if there is any pain in knee from the scale of 0 to 10. 6 weeks
Primary Q angle Measurement Subject will be in supine position with knee extension and quadriceps are relaxed, examiner will measure the q angle with flexible inch tape and goniometer. The Q- angle is measured by extending a line through the center of the patella to the anterior superior iliac spine and another line from the tibial tubercle through the center of the patella. 6 weeks
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