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Effect of Hip Abductors Versus Knee Extensor Strengthening in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis AND Hip Abductors AND Quadriceps

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with knee OA grade II- III Kellgren- Lawrence scores
  2. Their age is 50-70[Wang et al.,2019].
  3. Body mass index (BMI) 25-30.

Exclusion Criteria:

  1. Patients who had surgical intervention in the knee and/or hip.
  2. Fracture in the lower limbs.
  3. Malignancy
  4. Any associated ligamentous injuries in knee or ankle.
  5. Spinal Cord Injury.
  6. Hormonal imbalance or on hormonal therapy
  7. Knee injection within the last 6 months prior to the study.

Sites / Locations

  • Faculty of physical therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HAS group

KES group

Arm Description

hip abductors strengthening group Hip abduction -standing[Ferber et al.,2015]. Sidelying hip abduction(clamshell)[Schache et al.,2016]. lateral leg raise: in brief, the patients lie down on bed on the unaffected side, with the resistance band positioned around the distal thigh of the affected limb.;later, they raise the above lower limbs upwards for about 30 degrees, stay for 5- 10 s and slowly lay down[Xie et al.,2018]. pelvic lift training, specifically, patients stand single-leg off the side at a 10-cm step. Later, they begin with the other limb that is lower than the step level, and contract the stance-limb hip abductor to raise the free leg to the step level while keeping the stance knee extended[Xie et al.,2018]. Stretching Hamstrings [Fukuda et al.,2012]. Number of sets = 3, Repetitions =10 repetitions for each set

knee extensors strengthening group Isometric quadriceps setting Knee extensions from sitting with knee bend to 90 Terminal knee extension from sitting. Stretching Hamstrings Number of sets = 3, Repetitions =10 repetitions for each set

Outcomes

Primary Outcome Measures

Quadriceps Muscle Strength assessment
Quadriceps Muscle Strength assessment using Hand held Dynamometer
lower limb functional disability
Measuring lower limb functional disability using The Arabic version of reduced WOMAC (ArWOMAC) index
Knee function
Measuring function using The Timed Up & Go Test (TUG):

Secondary Outcome Measures

Full Information

First Posted
August 1, 2020
Last Updated
May 1, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04503304
Brief Title
Effect of Hip Abductors Versus Knee Extensor Strengthening in Knee Osteoarthritis
Official Title
Effect of Hip Abductors Versus Knee Extensor Strengthening on Pain,Function and Quadriceps Isometric Strength in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study will try to answer the following question: Would strengthening of hip abductors be equal to, or more effective than, knee extensors strengthening in improving pain, function and knee extensors isometric strength in patients with knee Osteoarthritis
Detailed Description
A total of 70 patients with knee Osteoarthritis will be recruited All patients who will participate in the study will be referred by orthopedists. Patients with knee osteoarthritis will be included with age ranges from 50-70. They will be randomized into 2 groups; hip abductors strengthening (HAS) group a will receive hip abductors strengthening exercises, and knee extensors strengthening (KES) group will receive quadriceps strengthening exercise. All patients who will meet the study criteria will get a complete knowledge of the objectives and procedures of the study. Inclusion criteria: Patients with knee Osteoarthritis grade II- III Kellgren- Lawrence scores Their age is 50-70[Wang et al.,2019]. Body mass index (BMI) 25-30. Exclusion criteria: Patients who had surgical intervention in the knee and/or hip. Fracture in the lower limbs. Malignancy Any associated ligamentous injuries in knee or ankle. Spinal Cord Injury. Hormonal imbalance or on hormonal therapy Knee injection within the last 6 months prior to the study. Outcome parameters including Quadriceps Muscle Strength, the arabic version of Western Ontario and McMaster Universities Arthritis Index questionnaire total score and 3 subscales and Timed Up and Go test score

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis AND Hip Abductors AND Quadriceps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups; hip abductors strengthening (HAS) group a will receive hip abductors strengthening exercises, and knee extensors strengthening (KES) group will receive quadriceps strengthening exercise.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAS group
Arm Type
Experimental
Arm Description
hip abductors strengthening group Hip abduction -standing[Ferber et al.,2015]. Sidelying hip abduction(clamshell)[Schache et al.,2016]. lateral leg raise: in brief, the patients lie down on bed on the unaffected side, with the resistance band positioned around the distal thigh of the affected limb.;later, they raise the above lower limbs upwards for about 30 degrees, stay for 5- 10 s and slowly lay down[Xie et al.,2018]. pelvic lift training, specifically, patients stand single-leg off the side at a 10-cm step. Later, they begin with the other limb that is lower than the step level, and contract the stance-limb hip abductor to raise the free leg to the step level while keeping the stance knee extended[Xie et al.,2018]. Stretching Hamstrings [Fukuda et al.,2012]. Number of sets = 3, Repetitions =10 repetitions for each set
Arm Title
KES group
Arm Type
Active Comparator
Arm Description
knee extensors strengthening group Isometric quadriceps setting Knee extensions from sitting with knee bend to 90 Terminal knee extension from sitting. Stretching Hamstrings Number of sets = 3, Repetitions =10 repetitions for each set
Intervention Type
Other
Intervention Name(s)
Exercises
Intervention Description
already included in arm/group descriptions.
Primary Outcome Measure Information:
Title
Quadriceps Muscle Strength assessment
Description
Quadriceps Muscle Strength assessment using Hand held Dynamometer
Time Frame
6 weeks
Title
lower limb functional disability
Description
Measuring lower limb functional disability using The Arabic version of reduced WOMAC (ArWOMAC) index
Time Frame
6 weeks
Title
Knee function
Description
Measuring function using The Timed Up & Go Test (TUG):
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with knee OA grade II- III Kellgren- Lawrence scores Their age is 50-70[Wang et al.,2019]. Body mass index (BMI) 25-30. Exclusion Criteria: Patients who had surgical intervention in the knee and/or hip. Fracture in the lower limbs. Malignancy Any associated ligamentous injuries in knee or ankle. Spinal Cord Injury. Hormonal imbalance or on hormonal therapy Knee injection within the last 6 months prior to the study.
Facility Information:
Facility Name
Faculty of physical therapy
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
protocol copy, informed consent, statistical analysis
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Effect of Hip Abductors Versus Knee Extensor Strengthening in Knee Osteoarthritis

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