Knee OsteoarthritisNCT04503304
Effect of Hip Abductors Versus Knee Extensor Strengthening in Knee Osteoarthritis
A study testing Exercises in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Hip Abductors Versus Knee Extensor Strengthening on Pain,Function and Quadriceps Isometric Strength in Knee Osteoarthritis
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
Read the 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
- Conditions
- Knee Osteoarthritis
- Being tested
- Exercises
- Keywords
- Knee Osteoarthritis AND Hip Abductors AND Quadriceps
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
already included in arm/group descriptions.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Muscle Strength assessment
Quadriceps Muscle Strength assessment using Hand held Dynamometer
Measured: 6 weeks
lower limb functional disability
Measuring lower limb functional disability using The Arabic version of reduced WOMAC (ArWOMAC) index
Measured: 6 weeks
Knee function
Measuring function using The Timed Up \& Go Test (TUG):
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Jul 2020
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aalaa Mohamed El-Amin Sweelam, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503304
- Sponsor's protocol ID
- Hip Abductors strength in KOA
- Status last verified
- May 2021
- First submitted
- 1 Aug 2020
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: protocol copy, informed consent, statistical analysis
Publications
Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.
PubMed 26223312Alghadir A, Anwer S, Iqbal ZA, Alsanawi HA. Cross-cultural adaptation, reliability and validity of the Arabic version of the reduced Western Ontario and McMaster Universities Osteoarthritis index in patients with knee osteoarthritis. Disabil Rehabil. 2016;38(7):689-94. doi: 10.3109/09638288.2015.1055380. Epub 2015 Jun 11.
PubMed 26066566Alnahdi AH, Zeni JA, Snyder-Mackler L. Hip abductor strength reliability and association with physical function after unilateral total knee arthroplasty: a cross-sectional study. Phys Ther. 2014 Aug;94(8):1154-62. doi: 10.2522/ptj.20130335. Epub 2014 Mar 20.
PubMed 24652473Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Gray R, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hand. Arthritis Rheum. 1990 Nov;33(11):1601-10. doi: 10.1002/art.1780331101.
PubMed 2242058Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505-14. doi: 10.1002/art.1780340502.
PubMed 2025304Al-Zahrani KS, Bakheit AM. A study of the gait characteristics of patients with chronic osteoarthritis of the knee. Disabil Rehabil. 2002 Mar 20;24(5):275-80. doi: 10.1080/09638280110087098.
PubMed 12004973Amin S, Baker K, Niu J, Clancy M, Goggins J, Guermazi A, Grigoryan M, Hunter DJ, Felson DT. Quadriceps strength and the risk of cartilage loss and symptom progression in knee osteoarthritis. Arthritis Rheum. 2009 Jan;60(1):189-98. doi: 10.1002/art.24182.
PubMed 19116936Arden N, Nevitt MC. Osteoarthritis: epidemiology. Best Pract Res Clin Rheumatol. 2006 Feb;20(1):3-25. doi: 10.1016/j.berh.2005.09.007.
PubMed 16483904Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
PubMed 3068365Bennell KL, Hunt MA, Wrigley TV, Hunter DJ, McManus FJ, Hodges PW, Li L, Hinman RS. Hip strengthening reduces symptoms but not knee load in people with medial knee osteoarthritis and varus malalignment: a randomised controlled trial. Osteoarthritis Cartilage. 2010 May;18(5):621-8. doi: 10.1016/j.joca.2010.01.010. Epub 2010 Feb 6.
PubMed 20175973Boling MC, Bolgla LA, Mattacola CG, Uhl TL, Hosey RG. Outcomes of a weight-bearing rehabilitation program for patients diagnosed with patellofemoral pain syndrome. Arch Phys Med Rehabil. 2006 Nov;87(11):1428-35. doi: 10.1016/j.apmr.2006.07.264.
PubMed 17084115Cools AM, Vanderstukken F, Vereecken F, Duprez M, Heyman K, Goethals N, Johansson F. Eccentric and isometric shoulder rotator cuff strength testing using a hand-held dynamometer: reference values for overhead athletes. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3838-3847. doi: 10.1007/s00167-015-3755-9. Epub 2015 Aug 21.
PubMed 26294055Costa RA, Oliveira LM, Watanabe SH, Jones A, Natour J. Isokinetic assessment of the hip muscles in patients with osteoarthritis of the knee. Clinics (Sao Paulo). 2010;65(12):1253-9. doi: 10.1590/s1807-59322010001200006.
PubMed 21340212Culvenor AG, Wirth W, Roth M, Hunter DJ, Eckstein F. Predictive Capacity of Thigh Muscle Strength in Symptomatic and/or Radiographic Knee Osteoarthritis Progression: Data from the Foundation for the National Institutes of Health Osteoarthritis Biomarkers Consortium. Am J Phys Med Rehabil. 2016 Dec;95(12):931-938. doi: 10.1097/PHM.0000000000000534.
PubMed 27175558Eckstein F, Wirth W, Nevitt MC. Recent advances in osteoarthritis imaging--the osteoarthritis initiative. Nat Rev Rheumatol. 2012 Oct;8(10):622-30. doi: 10.1038/nrrheum.2012.113. Epub 2012 Jul 10.
PubMed 22782003
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hip Abductors Versus Knee Extensor Strengthening on Pain,Function and Quadriceps Isometric Strength in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04503304
- Acronym / sponsor ID
- Hip Abductors strength in KOA
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis AND Hip Abductors AND Quadriceps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HAS group | Experimental | Other: Exerciseship 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 |
| KES group | Active comparator | Other: Exercisesknee 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 |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercisesalready included in arm/group descriptions. | Other | HAS group, KES group |
Primary outcome
Quadriceps Muscle Strength assessment
Time frame: 6 weeks
Quadriceps Muscle Strength assessment using Hand held Dynamometer
lower limb functional disability
Time frame: 6 weeks
Measuring lower limb functional disability using The Arabic version of reduced WOMAC (ArWOMAC) index
Knee function
Time frame: 6 weeks
Measuring function using The Timed Up \& Go Test (TUG):
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Background: PubMed 26223312Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.
- Background: PubMed 26066566Alghadir A, Anwer S, Iqbal ZA, Alsanawi HA. Cross-cultural adaptation, reliability and validity of the Arabic version of the reduced Western Ontario and McMaster Universities Osteoarthritis index in patients with knee osteoarthritis. Disabil Rehabil. 2016;38(7):689-94. doi: 10.3109/09638288.2015.1055380. Epub 2015 Jun 11.
- Background: PubMed 24652473Alnahdi AH, Zeni JA, Snyder-Mackler L. Hip abductor strength reliability and association with physical function after unilateral total knee arthroplasty: a cross-sectional study. Phys Ther. 2014 Aug;94(8):1154-62. doi: 10.2522/ptj.20130335. Epub 2014 Mar 20.
- Background: PubMed 2242058Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Gray R, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hand. Arthritis Rheum. 1990 Nov;33(11):1601-10. doi: 10.1002/art.1780331101.
- Background: PubMed 2025304Altman R, Alarcon G, Appelrouth D, Bloch D, Borenstein D, Brandt K, Brown C, Cooke TD, Daniel W, Feldman D, et al. The American College of Rheumatology criteria for the classification and reporting of osteoarthritis of the hip. Arthritis Rheum. 1991 May;34(5):505-14. doi: 10.1002/art.1780340502.
- Background: PubMed 12004973Al-Zahrani KS, Bakheit AM. A study of the gait characteristics of patients with chronic osteoarthritis of the knee. Disabil Rehabil. 2002 Mar 20;24(5):275-80. doi: 10.1080/09638280110087098.
- Background: PubMed 19116936Amin S, Baker K, Niu J, Clancy M, Goggins J, Guermazi A, Grigoryan M, Hunter DJ, Felson DT. Quadriceps strength and the risk of cartilage loss and symptom progression in knee osteoarthritis. Arthritis Rheum. 2009 Jan;60(1):189-98. doi: 10.1002/art.24182.
- Background: PubMed 16483904Arden N, Nevitt MC. Osteoarthritis: epidemiology. Best Pract Res Clin Rheumatol. 2006 Feb;20(1):3-25. doi: 10.1016/j.berh.2005.09.007.
- Background: PubMed 3068365Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 Dec;15(12):1833-40.
- Background: PubMed 20175973Bennell KL, Hunt MA, Wrigley TV, Hunter DJ, McManus FJ, Hodges PW, Li L, Hinman RS. Hip strengthening reduces symptoms but not knee load in people with medial knee osteoarthritis and varus malalignment: a randomised controlled trial. Osteoarthritis Cartilage. 2010 May;18(5):621-8. doi: 10.1016/j.joca.2010.01.010. Epub 2010 Feb 6.
- Background: PubMed 17084115Boling MC, Bolgla LA, Mattacola CG, Uhl TL, Hosey RG. Outcomes of a weight-bearing rehabilitation program for patients diagnosed with patellofemoral pain syndrome. Arch Phys Med Rehabil. 2006 Nov;87(11):1428-35. doi: 10.1016/j.apmr.2006.07.264.
- Background: PubMed 26294055Cools AM, Vanderstukken F, Vereecken F, Duprez M, Heyman K, Goethals N, Johansson F. Eccentric and isometric shoulder rotator cuff strength testing using a hand-held dynamometer: reference values for overhead athletes. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3838-3847. doi: 10.1007/s00167-015-3755-9. Epub 2015 Aug 21.
- Individual participant dataSharing planned: Yes. protocol copy, informed consent, statistical analysis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Knee Osteoarthritis, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quadriceps Muscle Strength assessment (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04503304, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.