Knee OsteoarthritisNCT06120920
Comparison of Hip Strengthening Exercises and Core Stability Exercises in Patients With Knee Osteoarthritis
A study testing Assigned Interventions and Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises. in people with Knee Osteoarthritis, run by University of Lahore at 1 site in Pakistan.
Trial summary
Knee Osteoarthritis is a chronic degenerative joint disease with complex etiology that results in loss of normal joint function due to damage to the articular cartilage. It is characterized by pain, swelling, inflammation and narrowing in articular cartilage. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Assigned Interventions and Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 30 Nov 2023
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 40-65
- Diagnose case of knee OA grade 2, 3.
- Side of involved leg: right or left.
- Unilateral knee.
- Gender both male and female.
- Pre-diagnostics referred by orthopedics.
- Able to walk without gait aids.
Who cannot join
- Inflammatory arthritis
- Osteoarthritis of the hips
- Having had previous knee or hip surgery.
- Patient who had amputated leg and who don't have any lower extremity disorders.
- Received intra-articular injection within 6 months.
- Non-steroidal anti-inflammatory drug or cortisone use over an extended period.
- Patients who had neurological and muscle problem
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
The University of Lahore
Lahore, Punjab Province, 54770
Muhammad Waqar Afzal, PhD, 0321-4668377, Waqarafzal621@gmail.com
Rashid Hafeez Nasir, M.Phill
About this study
Knee Osteoarthritis is a chronic degenerative joint disease with complex etiology that results in loss of normal joint function due to damage to the articular cartilage. It is characterized by pain, swelling, inflammation and narrowing in articular cartilage. Hip muscle weakness has been observed in persons with knee OA and poor core stability may be one of the other contributing factors that lead to knee OA development as well as its progression. Core stabilization and muscular synergism of the trunk and hip work is an effective way to improve lower limb strength balance and prevent injury. So the lumbopelvic stability is vital to support loads on the knee joint.
Read the detailed description
Osteoarthritis (OA) of the knee joint results in chronic pain and functional decline among older adults. Osteoarthritis is a degenerative joint disease with complex etiology that results in loss of normal joint function due to narrowing of the articular cartilage. The pathogenesis of knee OA is the result of interaction between mechanical loading, articular cartilage damage, and incomplete repair mechanisms. These changes eventually cause progressive joint degeneration and failure, leading to chronic knee pain and progressive restriction of knee joint mobility. Core muscle endurance deficiency leads to an increase in the loading of the knee, as well as in knee joint contact force during dynamic movement. Hence, poor core stability may be one of the contributing factors that lead to knee OA development as well as its progression. On the other hand hip muscle weakness has been observed in persons with knee OA and to increase the medial compartment loading on the knee joint. This increases the force on the medial compartment of the stance leg, and the disease starts succeeding. Core stabilization and muscular synergism of the trunk and hip work is an effective way to improve lower limb strength balance and prevent injury. Considering the strength deficits in the hip muscles as well as core muscles, a targeted exercise program for knee osteoarthritis include hip muscle strengthening and core strengthening might reduce the medial compartment loading and improve knee symptoms. Core stability and hip strengthening exercise along with Knee Physical therapy and conventional therapy as a mode of treatment in knee OA and it may help clinicians to treat subjects with knee OA at risk of a decline in muscle strength, range of motion, functional disability and pain.
- Conditions
- Knee Osteoarthritis
- Being tested
- Assigned Interventions, Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.
- Keywords
- Hip Strengthening Exercises, Core Stability Exercises, Routine Knee Strengthening Exercises, Conventional Physical Therapy, Pain Assessment, Range of Motion, Functional Disability, Knee Muscle Strength, Time Up and Go Test
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assigned InterventionsOther
Also called Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises.
Conventional physical therapy consists of hot pack application and transcutaneous electric stimulation (TENS) and routine knee strengthening exercises in addition with core stability exercises in three sessions per week for 4 weeks. Core stability exercises include bent knee hollow hold, bridging, supine toe tap and knee strengthening exercises include knee flexion strengthening exercises and knee extension isometric exercises.
Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.Other
Conventional physical therapy consists of hot pack application, Tens and routine knee exercise program same as group A and in addition with hip strengthening exercises. Hip strengthening exercises include hip flexion and extension strengthening exercises and hip internal rotation and external rotation and hip adduction and abduction strengthening exercises.C
| Study group | Role | What they receive |
|---|---|---|
| Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises. | Active comparator | Patient will receive Conventional physical therapy include hot pack, Tens and routine knee strengthening exercises with core stability exercises. Receives: Other: Assigned Interventions; Other: Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises. |
| Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises. | Experimental | In this group, patient will receive conventional physical therapy include hot pack, Tens and routine knee exercises with hip strengthening exercises Receives: Other: Assigned Interventions; Other: Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Assessment
Pain intensity will be measured using Visual Analogue Scale. It consist of a 100mm line, with to end points, 0 representing no pain and 10 representing pain as bad as it could be possible.
Measured: Pain intensity will be measured at the baseline at the time of recruitment and change in pain intensity will be measured at 3rd and 4th week of interventions
Knee Range of Motion
ROM is measured by goniometer.: A normal range of knee joint is 0 degrees of knee extension (a fully straightened knee) and 135 degrees of knee flexion.A half circle long-arm metallic goniometer, ranging from 0 to 180°, with 1° interval marking was used. It had a central fulcrum, a stationary or fixed arm, and a pivoting or moving arm. Both arms were 30 cm long.
Measured: Knee Range of Motion will be measured as baseline at the time of recruitment and change in range of motion will be measured at 3rd and 4th week of treatment.
Functional Disability
The functional disability assessed by the self-reported questionnaire the Knee injury and Osteoarthritis Outcome Score (KOOS).Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: Level of Functional Disability will be recorded as baseline at the time of recruitment and change in functional status will be observed at the 3rd and 4th week of intervention.
Knee Muscle Strength
Knee Muscle Strength will be observed by Manual Muscle Testing Scale. This method involves testing key muscles from the lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly 1.Flicker of movement,2.through full range actively with gravity counterbalanced,3.through full range actively against gravity,4.through full range actively against some resistance,5.Through full range actively against strong resistance.
Measured: Knee Muscle Strength will be observed as baseline at the time of recruitment and change in muscle strength will be observed at the 3rd and 4th week of treatment
Secondary outcomes (1)
Timed Up and Go Test (TUG)
TUG is used to evaluate function. It assesses the patient's capability to stand from the chair, then walk for three meters, turn, walk back, and sit on the same chair. The TUG is highly responsive and valid to determine alteration in patients with OA of the knee. The minimum clinically important differences (MCID) is reported to be 0.8-1.4s for the TUG in patients with OA of the knee.
Measured: Time Up and Go Test will be observed as baseline at the time of recruitment and change in function will be observed at 3rd and 4th week of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion21 Nov 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Waqar Afzal, PhD, Study chair, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120920
- Sponsor's protocol ID
- REC-UOL-545-10-2023
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants data that underlies the results after de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hip Strengthening Exercises and Core Stability Exercises in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06120920
- Acronym / sponsor ID
- REC-UOL-545-10-2023
- Conditions
- Knee Osteoarthritis
- Keywords
- Hip Strengthening Exercises, Core Stability Exercises, Routine Knee Strengthening Exercises, Conventional Physical Therapy, Pain Assessment, Range of Motion, Functional Disability, Knee Muscle Strength
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 21 Nov 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 7 Nov 2023 (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.
Knee Osteoarthritis is a chronic degenerative joint disease with complex etiology that results in loss of normal joint function due to damage to the articular cartilage. It is characterized by pain, swelling, inflammation and narrowing in articular cartilage. Hip muscle weakness has been observed in persons with knee OA and poor core stability may be one of the other contributing factors that lead to knee OA development as well as its progression. Core stabilization and muscular synergism of the trunk and hip work is an effective way to improve lower limb strength balance and prevent injury. So the lumbopelvic stability is vital to support loads on the knee joint.
Detailed description
Osteoarthritis (OA) of the knee joint results in chronic pain and functional decline among older adults. Osteoarthritis is a degenerative joint disease with complex etiology that results in loss of normal joint function due to narrowing of the articular cartilage. The pathogenesis of knee OA is the result of interaction between mechanical loading, articular cartilage damage, and incomplete repair mechanisms. These changes eventually cause progressive joint degeneration and failure, leading to chronic knee pain and progressive restriction of knee joint mobility. Core muscle endurance deficiency leads to an increase in the loading of the knee, as well as in knee joint contact force during dynamic movement. Hence, poor core stability may be one of the contributing factors that lead to knee OA development as well as its progression. On the other hand hip muscle weakness has been observed in persons with knee OA and to increase the medial compartment loading on the knee joint. This increases the force on the medial compartment of the stance leg, and the disease starts succeeding. Core stabilization and muscular synergism of the trunk and hip work is an effective way to improve lower limb strength balance and prevent injury. Considering the strength deficits in the hip muscles as well as core muscles, a targeted exercise program for knee osteoarthritis include hip muscle strengthening and core strengthening might reduce the medial compartment loading and improve knee symptoms. Core stability and hip strengthening exercise along with Knee Physical therapy and conventional therapy as a mode of treatment in knee OA and it may help clinicians to treat subjects with knee OA at risk of a decline in muscle strength, range of motion, functional disability and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises. | Active comparator | Other: Assigned Interventions, Other: Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.Patient will receive Conventional physical therapy include hot pack, Tens and routine knee strengthening exercises with core stability exercises. |
| Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises. | Experimental | Other: Assigned Interventions, Other: Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.In this group, patient will receive conventional physical therapy include hot pack, Tens and routine knee exercises with hip strengthening exercises |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age: 40-65
- Diagnose case of knee OA grade 2, 3.
- Side of involved leg: right or left.
- Unilateral knee.
- Gender both male and female.
Key exclusion criteria (7 listed)
- Inflammatory arthritis
- Osteoarthritis of the hips
- Having had previous knee or hip surgery.
- Patient who had amputated leg and who don't have any lower extremity disorders.
- Received intra-articular injection within 6 months.
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 |
|---|---|---|
| Assigned InterventionsAlso: Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises.Conventional physical therapy consists of hot pack application and transcutaneous electric stimulation (TENS) and routine knee strengthening exercises in addition with core stability exercises in three sessions per week for 4 weeks. Core stability exercises include bent knee hollow hold, bridging, supine toe tap and knee strengthening exercises include knee flexion strengthening exercises and knee extension isometric exercises. | Other | Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises., Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises. |
| Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises.Conventional physical therapy consists of hot pack application, Tens and routine knee exercise program same as group A and in addition with hip strengthening exercises. Hip strengthening exercises include hip flexion and extension strengthening exercises and hip internal rotation and external rotation and hip adduction and abduction strengthening exercises.C | Other | Conventional Physical Therapy and Routine Knee Exercises with Core Stability Exercises., Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises. |
Primary outcome
Pain Assessment
Time frame: Pain intensity will be measured at the baseline at the time of recruitment and change in pain intensity will be measured at 3rd and 4th week of interventions
Pain intensity will be measured using Visual Analogue Scale. It consist of a 100mm line, with to end points, 0 representing no pain and 10 representing pain as bad as it could be possible.
Knee Range of Motion
Time frame: Knee Range of Motion will be measured as baseline at the time of recruitment and change in range of motion will be measured at 3rd and 4th week of treatment.
ROM is measured by goniometer.: A normal range of knee joint is 0 degrees of knee extension (a fully straightened knee) and 135 degrees of knee flexion.A half circle long-arm metallic goniometer, ranging from 0 to 180°, with 1° interval marking was used. It had a central fulcrum, a stationary or fixed arm, and a pivoting or moving arm. Both arms were 30 cm long.
Functional Disability
Time frame: Level of Functional Disability will be recorded as baseline at the time of recruitment and change in functional status will be observed at the 3rd and 4th week of intervention.
The functional disability assessed by the self-reported questionnaire the Knee injury and Osteoarthritis Outcome Score (KOOS).Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Knee Muscle Strength
Time frame: Knee Muscle Strength will be observed as baseline at the time of recruitment and change in muscle strength will be observed at the 3rd and 4th week of treatment
Knee Muscle Strength will be observed by Manual Muscle Testing Scale. This method involves testing key muscles from the lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale accordingly 1.Flicker of movement,2.through full range actively with gravity counterbalanced,3.through full range actively against gravity,4.through full range actively against some resistance,5.Through full range actively against strong resistance.
1 secondary outcome
Timed Up and Go Test (TUG)
Time frame: Time Up and Go Test will be observed as baseline at the time of recruitment and change in function will be observed at 3rd and 4th week of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: Yes. Participants data that underlies the results after de-identification.
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Dr.Waqar Afzal, PhD study chair
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assigned Interventions and Conventional Physical Therapy and Routine Knee Exercises with Hip Strengthening Exercises. in people with Knee Osteoarthritis, run by University of Lahore at 1 site in Pakistan.
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 7 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. 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 Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashfaq Ahmad, PhD (0300-9449192, ashfaq.ahmad@uipt.uol.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Assessment (time frame: Pain intensity will be measured at the baseline at the time of recruitment and change in pain intensity will be measured at 3rd and 4th week of interventions). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Nov 2023.