NCT04503304

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Jul 2020

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

May 4, 2021

Status Verified

May 1, 2021

Enrollment Period

4 months

First QC Date

August 1, 2020

Last Update Submit

May 1, 2021

Conditions

Keywords

Knee Osteoarthritis AND Hip Abductors AND Quadriceps

Outcome Measures

Primary Outcomes (3)

  • Quadriceps Muscle Strength assessment

    Quadriceps Muscle Strength assessment using Hand held Dynamometer

    6 weeks

  • lower limb functional disability

    Measuring lower limb functional disability using The Arabic version of reduced WOMAC (ArWOMAC) index

    6 weeks

  • Knee function

    Measuring function using The Timed Up \& Go Test (TUG):

    6 weeks

Study Arms (2)

HAS group

EXPERIMENTAL

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

KES group

ACTIVE COMPARATOR

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

Interventions

already included in arm/group descriptions.

HAS groupKES group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Cairo, Egypt

Location

Related Publications (47)

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    PMID: 21041965BACKGROUND
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    PMID: 22951491BACKGROUND
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    PMID: 23973125BACKGROUND
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    PMID: 20704005BACKGROUND
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    PMID: 29408538BACKGROUND
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  • Kemnitz J, Wirth W, Eckstein F, Ruhdorfer A, Culvenor AG. Longitudinal change in thigh muscle strength prior to and concurrent with symptomatic and radiographic knee osteoarthritis progression: data from the Osteoarthritis Initiative. Osteoarthritis Cartilage. 2017 Oct;25(10):1633-1640. doi: 10.1016/j.joca.2017.07.003. Epub 2017 Jul 8.

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant

Study Record Dates

First Submitted

August 1, 2020

First Posted

August 7, 2020

Study Start

July 1, 2020

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

May 4, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

protocol copy, informed consent, statistical analysis

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations