NCT05058794

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 28, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

October 10, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

4 months

First QC Date

September 17, 2021

Last Update Submit

March 8, 2022

Conditions

Keywords

OsteoarthritisBlood Flow RestrictionQuadricepsResistance Training

Outcome Measures

Primary Outcomes (4)

  • Muscle strength

    Measurement of Quadriceps strength with portable weight machine.

    6 weeks

  • 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

  • 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

  • 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

Study Arms (2)

Resistance exercise group

EXPERIMENTAL

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.

Other: Blood flow Restriction/Resistance Training

Conventional Therapy Group

ACTIVE COMPARATOR

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.

Other: Conventional Therapy Group

Interventions

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.

Resistance exercise 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.)

Conventional Therapy Group

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Gulberg Medical Complex

Islamabad, Federal, 44000, Pakistan

Location

Medcity International Hospital

Islamabad, Federal, 44000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, KneeHypertrophyOsteoarthritis

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Saad Rauf, Master

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2021

First Posted

September 28, 2021

Study Start

October 10, 2021

Primary Completion

February 11, 2022

Study Completion

February 11, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations