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Comparison Among the Effects of Blood Flow Restriction Training and Conventional Exercise in Knee Osteoarthritis.

Primary Purpose

Osteoarthritis, Knee, Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Blood flow Restriction/Resistance Training
Conventional Therapy Group
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Osteoarthritis, Blood Flow Restriction, Quadriceps, Resistance Training

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Gulberg Medical Complex
  • Medcity International Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Resistance exercise group

Conventional Therapy Group

Arm Description

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 LOP was calculated in the body position that the blood flow restriction (BFR) stimulus would be applied. 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. Secondly, Rest between sets (1 min) Therapist will help these positions to maintain Knee extension and Wall Squatting. The study includes interventional protocol of 6 weeks. Total sessions will be 12 and in each week there will 2 sessions with alternative days and follow up.

Patients in this group will receive treatment via Knee extension,Wall squatting Each training session includes 3 minutes warm-up.First, participants will perform 2 sets with 15 repetitions in (0 to 90 degree.) Secondly, Rest between sets (1 min) Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally. The study includes interventional protocol of 6 weeks. The sessions will be given on 2 alternate days making it a total of 12 sessions and then follow up.

Outcomes

Primary Outcome Measures

Muscle strength
Measurement of Quadriceps strength with portable weight machine.
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.
Numeric Pain Rating Scale ( NPRS)
Patient will be asked if there is any pain in knee from the scale of 0 to 10.
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.

Secondary Outcome Measures

Full Information

First Posted
September 17, 2021
Last Updated
March 8, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05058794
Brief Title
Comparison Among the Effects of Blood Flow Restriction Training and Conventional Exercise in Knee Osteoarthritis.
Official Title
Effects of Blood Flow Restriction Training vs Traditional Exercise in Patients With Knee Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
February 11, 2022 (Actual)
Study Completion Date
February 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee, Hypertrophy
Keywords
Osteoarthritis, Blood Flow Restriction, Quadriceps, Resistance Training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Resistance exercise group
Arm Type
Experimental
Arm Description
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 LOP was calculated in the body position that the blood flow restriction (BFR) stimulus would be applied. 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. Secondly, Rest between sets (1 min) Therapist will help these positions to maintain Knee extension and Wall Squatting. The study includes interventional protocol of 6 weeks. Total sessions will be 12 and in each week there will 2 sessions with alternative days and follow up.
Arm Title
Conventional Therapy Group
Arm Type
Active Comparator
Arm Description
Patients in this group will receive treatment via Knee extension,Wall squatting Each training session includes 3 minutes warm-up.First, participants will perform 2 sets with 15 repetitions in (0 to 90 degree.) Secondly, Rest between sets (1 min) Resistance applied for 1 minute (60 sec) with 30 % load of 1 repetition maximum. Subjects will receive treatment bilaterally. The study includes interventional protocol of 6 weeks. The sessions will be given on 2 alternate days making it a total of 12 sessions and then follow up.
Intervention Type
Other
Intervention Name(s)
Blood flow Restriction/Resistance Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional Therapy Group
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Muscle strength
Description
Measurement of Quadriceps strength with portable weight machine.
Time Frame
6 weeks
Title
Thigh Girth
Description
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.
Time Frame
6 weeks
Title
Numeric Pain Rating Scale ( NPRS)
Description
Patient will be asked if there is any pain in knee from the scale of 0 to 10.
Time Frame
6 weeks
Title
Q angle Measurement
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saad Rauf, Master
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gulberg Medical Complex
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan
Facility Name
Medcity International Hospital
City
Islamabad
State/Province
Federal
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison Among the Effects of Blood Flow Restriction Training and Conventional Exercise in Knee Osteoarthritis.

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