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Effect of Hip Abductors Versus Knee Extensor Strengthening in Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04503304
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
Aalaa Mohamed El-Amin Sweelam, Cairo University

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


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Other: Exercises Not Applicable

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:

  1. Patients with knee Osteoarthritis 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. 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Effect of Hip Abductors Versus Knee Extensor Strengthening on Pain,Function and Quadriceps Isometric Strength in Knee Osteoarthritis
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: HAS group

hip abductors strengthening group

  1. Hip abduction -standing[Ferber et al.,2015].
  2. Sidelying hip abduction(clamshell)[Schache et al.,2016].
  3. 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].
  4. 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].
  5. Stretching Hamstrings [Fukuda et al.,2012]. Number of sets = 3, Repetitions =10 repetitions for each set
Other: Exercises
already included in arm/group descriptions.

Active Comparator: KES group

knee extensors strengthening group

  1. Isometric quadriceps setting
  2. Knee extensions from sitting with knee bend to 90
  3. Terminal knee extension from sitting.
  4. Stretching Hamstrings Number of sets = 3, Repetitions =10 repetitions for each set
Other: Exercises
already included in arm/group descriptions.




Primary Outcome Measures :
  1. Quadriceps Muscle Strength assessment [ Time Frame: 6 weeks ]
    Quadriceps Muscle Strength assessment using Hand held Dynamometer

  2. lower limb functional disability [ Time Frame: 6 weeks ]
    Measuring lower limb functional disability using The Arabic version of reduced WOMAC (ArWOMAC) index

  3. Knee function [ Time Frame: 6 weeks ]
    Measuring function using The Timed Up & Go Test (TUG):



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503304


Contacts
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Contact: Aalaa Mohamed Sweelam, PhD 01007290527 asweelam@ecu.edu.eg
Contact: Mohamed Shawki 01287232366

Locations
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Egypt
Faculty of physical therapy Recruiting
Cairo, Egypt
Contact: Physical therapy         
Sponsors and Collaborators
Cairo University
Publications:

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Responsible Party: Aalaa Mohamed El-Amin Sweelam, Teaching Assistant, Cairo University
ClinicalTrials.gov Identifier: NCT04503304    
Other Study ID Numbers: Hip Abductors strength in KOA
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: September 11, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: protocol copy, informed consent, statistical analysis
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aalaa Mohamed El-Amin Sweelam, Cairo University:
Knee Osteoarthritis AND Hip Abductors AND Quadriceps
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases