Knee Osteoarthritis (OA)NCT06658249
Effects of Core Stabilization Exercises Versus Foot-Ankle Strengthening Program in Patients With Knee Osteoarthritis.
A study testing Core Stabilization Exercises with Foot-Ankle Strengthening Program and Foot-Ankle Strengthening Program in people with Knee Osteoarthritis (OA), run by Riphah International University at 1 site in Pakistan.
Trial summary
Knee osteoarthritis (OA) is also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage. It is most common in the elder population. It results from functional disability and altered knee biomechanics. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Knee Osteoarthritis (OA)
- What is being tested?
- Core Stabilization Exercises with Foot-Ankle Strengthening Program and Foot-Ankle Strengthening Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Jan 2024to 7 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Both genders of 40-65 years of age will include in this study.
- Knee OA of grade 1-2.
- Individuals with significant unilateral and bilateral knee osteoarthritis. symptoms and positive radio-graphical findings.
- Difficulty in walking/stair climbing.
Who cannot join
- Any history of knee fracture/ tumor/ infection and hip/knee surgery.
- Total Knee Replacement patients.
- Neurological disease.
- Patient received physical therapy treatment from last 6 months.
- Inflammatory Arthritis (Rheumatoid Arthritis)
- Use of any intra-articular injections (steroid/ hyaluronic acid/ PRP.) from last 3-6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Fatima Memorial Hospital Physical Therapy Department
Lahore, Punjab Province, 25000
Usman Riaz, MS-OMPT, 03324708805, usman.riaz@gmail.com
Areej Kulsoom, MS-OMPT
About this study
Official title: Comparative Effects of Core Stabilization Exercises Versus Foot-Ankle Strengthening Program on Pain, Physical Function and Quality of Life in Patients With Knee Osteoarthritis.
Knee osteoarthritis (OA) is also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage. It is most common in the elder population. It results from functional disability and altered knee biomechanics. Risk factors of Knee OA include; older age, genetics and obesity, female gender. The aim of this study is to compare the effects of core stabilization exercises versus foot-ankle strengthening program on pain, physical function and quality of life in patients with knee osteoarthritis.
Read the detailed description
A Randomized Clinical Trial will be conducted at Riphah Physiotherapy Clinic Lahore, FMH Physiotherapy Department, Hamza Hospital Physiotherapy Clinic, Lahore through convenient purposive sampling technique 46 patients which will be allocated by using simple randomization through computer generated software into Group A and Group B. Group A will be treated with core stabilization exercises and ankle-foot strengthening program and Group B will be treated with ankle-foot strengthening program at the frequency of 3 sets with 10 repetitions thrice per week in the total duration of 6 weeks. Outcome measures will be conducted through (NPRS), (WOMAC), Knee Osteoarthritis Outcome Score (KOOS) Questionnaire and quality of life (SF-36) questionnaire before and after 6 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
- Conditions
- Knee Osteoarthritis (OA)
- Being tested
- Core Stabilization Exercises with Foot-Ankle Strengthening Program, Foot-Ankle Strengthening Program
- Keywords
- Knee Osteoarthritis, Pain, Physical Function, Quality of Life
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Stabilization Exercises with Foot-Ankle Strengthening ProgramOther
Also called Simple Conventional Treatment
Core Stabilization Exercises and Foot-Ankle Strengthening Program with the frequency of 3 sets of 10 repetitions 3 times per week for a total duration of 6 weeks. Core Stabilization Exercises include : Double leg Abdominal Press, Single Leg Abdominal Press, Abdominal crunches, Side-lying Hip Abduction, Bridging Exercise, Wall Squats Exercise. Foot-Ankle Strengthening Program include : Step ups Exercise, Heel Raises in standing/sitting, Toe Raises in standing/sitting, Foot-Ankle isometrics with theraband, One leg balance with chair support. Pre and Post intervention values will be taken on 1st day and after 6 weeks. Simple Conventional treatment will also given that include Hot Pack and TENS for 10 minutes and Ultrasound for 5 minutes and Knee Isometric exercises with the frequency of 1 set of 10 repetitions with 5 sec hold with the ratio of 3 times per week for a total duration of 6 weeks.
Foot-Ankle Strengthening ProgramOther
Also called Simple Conventional Treatment
Foot-Ankle Strengthening Program along with common conventional treatment with the frequency of 3 sets of 10 repetition thrice per week for a total duration of 6 weeks. Core Stabilization Exercises include : Double leg Abdominal Press, Single Leg Abdominal Press, Abdominal crunches, Side-lying Hip Abduction, Bridging Exercise, Wall Squats Exercise. Foot-Ankle Strengthening Program include : Step ups Exercise, Heel Raises in standing/sitting, Toe Raises in standing/sitting, Foot-Ankle isometrics with theraband, One leg balance with chair support. Pre and Post intervention values will be taken on 1st day and after 6 weeks. Simple Conventional treatment will also given that include Hot Pack and TENS for 10 minutes and Ultrasound for 5 minutes and Knee Isometric exercises with the frequency of 1 set of 10 repetitions with 5 sec hold with the ratio of 3 times per week for a total duration of 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Core Stabilization Exercises with Foot-Ankle Strengthening Program | Experimental | Core Stabilization Exercises with Foot-Ankle Strengthening Program along with simple conventional treatment. Receives: Other: Core Stabilization Exercises with Foot-Ankle Strengthening Program |
| Foot-Ankle Strengthening Program | Active comparator | Foot-Ankle Strengthening Program along with simple conventional treatment Receives: Other: Foot-Ankle Strengthening Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Changes from baseline, Numeric Rating Scale (NRS) is the most commonly used scale in which the pain rate ranges from 0 (no pain) to 10 (worst pain). The level of knee perception of pain is assessed by using the NPRS. It is used as the outcome measure tool for patients with OA knee. The NPRS is consider as reliable, valid, and responsive scale for pain. This scale has high reliability (0.95-0.96).
The validity of NPRS ranges from (0.86-0.95).
Measured: 6 weeks
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
Changes from baseline, KOOS score consist of five patient-relevant dimensions that are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. This scale consist of total 42-items and score of this scale range from 0 (severe knee pathology) to 100 (no knee problem). This tool has been use to assess the pain, symptoms, activities level, function in knee osteoarthritis patients. It is a valid tool for Knee Osteoarthritis patients ; validity ranges up-to (0.80-0.89).
Measured: 6 weeks
WESTREN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC SCALE)
Changes from baseline, WOMAC scale consist of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores have been represent worse pain, stiffness, and functional limitations. This scale will be use to assess pain, stiffness, physical function level in knee osteoarthritis patients.
Measured: 6 weeks
36- Items Short Form Survey (SF-36) QUESTIONNAIRE
Changes from baseline, Quality of life scale (SF-36) questionnaire consist of subscale of general health, activities limitations, physical health problems, emotional health problems, social activities, energy and emotions; total 36 items in it. SF-36 is used to assess the quality of life in knee osteoarthritis patient. SF-36 questionnaire is reliable and valid tool for quality of life in knee osteoarthritis individuals.
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 posted26 Oct 2024
- Study start4 Jan 2024
- Primary completion7 Jan 2025 (estimated)
- Study completion7 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis (OA)Studies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Raza, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658249
- Sponsor's protocol ID
- REC/RCR & AHS/24/0132
- Status last verified
- Nov 2024
- First submitted
- 24 Oct 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oiestad BE, Aroen A, Rotterud JH, Osteras N, Jarstad E, Grotle M, Risberg MA. The efficacy of strength or aerobic exercise on quality of life and knee function in patients with knee osteoarthritis. A multi-arm randomized controlled trial with 1-year follow-up. BMC Musculoskelet Disord. 2023 Sep 8;24(1):714. doi: 10.1186/s12891-023-06831-x.
PubMed 37684597Holm PM, Schroder HM, Wernbom M, Skou ST. Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial. Osteoarthritis Cartilage. 2020 Jun;28(6):744-754. doi: 10.1016/j.joca.2020.02.839. Epub 2020 Mar 13.
PubMed 32179197Hernandez D, Dimaro M, Navarro E, Dorado J, Accoce M, Salzberg S, Policastro PO. Efficacy of core exercises in patients with osteoarthritis of the knee: A randomized controlled clinical trial. J Bodyw Mov Ther. 2019 Oct;23(4):881-887. doi: 10.1016/j.jbmt.2019.06.002. Epub 2019 Jun 4.
PubMed 31733777GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.
PubMed 37675071
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Core Stabilization Exercises Versus Foot-Ankle Strengthening Program on Pain, Physical Function and Quality of Life in Patients With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06658249
- Acronym / sponsor ID
- REC/RCR & AHS/24/0132
- Conditions
- Knee Osteoarthritis (OA)
- Keywords
- Knee Osteoarthritis, Pain, Physical Function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Jan 2024 (actual)
- Primary completion
- 7 Jan 2025 (estimated)
- Study completion
- 7 Jan 2025 (estimated)
- First posted
- 26 Oct 2024 (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 (OA) is also known as degenerative joint disease, is typically the result of wear and tear and progressive loss of articular cartilage. It is most common in the elder population. It results from functional disability and altered knee biomechanics. Risk factors of Knee OA include; older age, genetics and obesity, female gender. The aim of this study is to compare the effects of core stabilization exercises versus foot-ankle strengthening program on pain, physical function and quality of life in patients with knee osteoarthritis.
Detailed description
A Randomized Clinical Trial will be conducted at Riphah Physiotherapy Clinic Lahore, FMH Physiotherapy Department, Hamza Hospital Physiotherapy Clinic, Lahore through convenient purposive sampling technique 46 patients which will be allocated by using simple randomization through computer generated software into Group A and Group B. Group A will be treated with core stabilization exercises and ankle-foot strengthening program and Group B will be treated with ankle-foot strengthening program at the frequency of 3 sets with 10 repetitions thrice per week in the total duration of 6 weeks. Outcome measures will be conducted through (NPRS), (WOMAC), Knee Osteoarthritis Outcome Score (KOOS) Questionnaire and quality of life (SF-36) questionnaire before and after 6 weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Stabilization Exercises with Foot-Ankle Strengthening Program | Experimental | Other: Core Stabilization Exercises with Foot-Ankle Strengthening ProgramCore Stabilization Exercises with Foot-Ankle Strengthening Program along with simple conventional treatment. |
| Foot-Ankle Strengthening Program | Active comparator | Other: Foot-Ankle Strengthening ProgramFoot-Ankle Strengthening Program along with simple conventional treatment |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both genders of 40-65 years of age will include in this study.
- Knee OA of grade 1-2.
- Individuals with significant unilateral and bilateral knee osteoarthritis. symptoms and positive radio-graphical findings.
- Difficulty in walking/stair climbing.
Key exclusion criteria (6 listed)
- Any history of knee fracture/ tumor/ infection and hip/knee surgery.
- Total Knee Replacement patients.
- Neurological disease.
- Patient received physical therapy treatment from last 6 months.
- Inflammatory Arthritis (Rheumatoid Arthritis)
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 |
|---|---|---|
| Core Stabilization Exercises with Foot-Ankle Strengthening ProgramAlso: Simple Conventional TreatmentCore Stabilization Exercises and Foot-Ankle Strengthening Program with the frequency of 3 sets of 10 repetitions 3 times per week for a total duration of 6 weeks. Core Stabilization Exercises include : Double leg Abdominal Press, Single Leg Abdominal Press, Abdominal crunches, Side-lying Hip Abduction, Bridging Exercise, Wall Squats Exercise. Foot-Ankle Strengthening Program include : Step ups Exercise, Heel Raises in standing/sitting, Toe Raises in standing/sitting, Foot-Ankle isometrics with theraband, One leg balance with chair support. Pre and Post intervention values will be taken on 1st day and after 6 weeks. Simple Conventional treatment will also given that include Hot Pack and TENS for 10 minutes and Ultrasound for 5 minutes and Knee Isometric exercises with the frequency of 1 set of 10 repetitions with 5 sec hold with the ratio of 3 times per week for a total duration of 6 weeks. | Other | Core Stabilization Exercises with Foot-Ankle Strengthening Program |
| Foot-Ankle Strengthening ProgramAlso: Simple Conventional TreatmentFoot-Ankle Strengthening Program along with common conventional treatment with the frequency of 3 sets of 10 repetition thrice per week for a total duration of 6 weeks. Core Stabilization Exercises include : Double leg Abdominal Press, Single Leg Abdominal Press, Abdominal crunches, Side-lying Hip Abduction, Bridging Exercise, Wall Squats Exercise. Foot-Ankle Strengthening Program include : Step ups Exercise, Heel Raises in standing/sitting, Toe Raises in standing/sitting, Foot-Ankle isometrics with theraband, One leg balance with chair support. Pre and Post intervention values will be taken on 1st day and after 6 weeks. Simple Conventional treatment will also given that include Hot Pack and TENS for 10 minutes and Ultrasound for 5 minutes and Knee Isometric exercises with the frequency of 1 set of 10 repetitions with 5 sec hold with the ratio of 3 times per week for a total duration of 6 weeks. | Other | Foot-Ankle Strengthening Program |
Primary outcome
Numeric Pain Rating Scale
Time frame: 6 weeks
Changes from baseline, Numeric Rating Scale (NRS) is the most commonly used scale in which the pain rate ranges from 0 (no pain) to 10 (worst pain). The level of knee perception of pain is assessed by using the NPRS. It is used as the outcome measure tool for patients with OA knee. The NPRS is consider as reliable, valid, and responsive scale for pain. This scale has high reliability (0.95-0.96). The validity of NPRS ranges from (0.86-0.95).
Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
Time frame: 6 weeks
Changes from baseline, KOOS score consist of five patient-relevant dimensions that are scored separately: Pain (nine items); Symptoms (seven items); ADL Function (17 items); Sport and Recreation Function (five items); Quality of Life (four items). A Likert scale is used and all items have five possible answer options scored from 0 (No problems) to 4 (Extreme problems) and each of the five scores is calculated as the sum of the items included. This scale consist of total 42-items and score of this scale range from 0 (severe knee pathology) to 100 (no knee problem). This tool has been use to assess the pain, symptoms, activities level, function in knee osteoarthritis patients. It is a valid tool for Knee Osteoarthritis patients ; validity ranges up-to (0.80-0.89).
WESTREN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC SCALE)
Time frame: 6 weeks
Changes from baseline, WOMAC scale consist of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores have been represent worse pain, stiffness, and functional limitations. This scale will be use to assess pain, stiffness, physical function level in knee osteoarthritis patients.
36- Items Short Form Survey (SF-36) QUESTIONNAIRE
Time frame: 6 weeks
Changes from baseline, Quality of life scale (SF-36) questionnaire consist of subscale of general health, activities limitations, physical health problems, emotional health problems, social activities, energy and emotions; total 36 items in it. SF-36 is used to assess the quality of life in knee osteoarthritis patient. SF-36 questionnaire is reliable and valid tool for quality of life in knee osteoarthritis individuals.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Background: PubMed 37684597Oiestad BE, Aroen A, Rotterud JH, Osteras N, Jarstad E, Grotle M, Risberg MA. The efficacy of strength or aerobic exercise on quality of life and knee function in patients with knee osteoarthritis. A multi-arm randomized controlled trial with 1-year follow-up. BMC Musculoskelet Disord. 2023 Sep 8;24(1):714. doi: 10.1186/s12891-023-06831-x.
- Background: PubMed 32179197Holm PM, Schroder HM, Wernbom M, Skou ST. Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial. Osteoarthritis Cartilage. 2020 Jun;28(6):744-754. doi: 10.1016/j.joca.2020.02.839. Epub 2020 Mar 13.
- Background: PubMed 31733777Hernandez D, Dimaro M, Navarro E, Dorado J, Accoce M, Salzberg S, Policastro PO. Efficacy of core exercises in patients with osteoarthritis of the knee: A randomized controlled clinical trial. J Bodyw Mov Ther. 2019 Oct;23(4):881-887. doi: 10.1016/j.jbmt.2019.06.002. Epub 2019 Jun 4.
- Background: PubMed 37675071GBD 2021 Osteoarthritis Collaborators. Global, regional, and national burden of osteoarthritis, 1990-2020 and projections to 2050: a systematic analysis for the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023 Aug 21;5(9):e508-e522. doi: 10.1016/S2665-9913(23)00163-7. eCollection 2023 Sep.
- Individual participant dataSharing planned: No
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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.
Ali Raza, MS-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization Exercises with Foot-Ankle Strengthening Program and Foot-Ankle Strengthening Program in people with Knee Osteoarthritis (OA), run by Riphah International University 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 6 weeks). 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?
On the ClinicalTrials.gov record for NCT06658249, which also lists 4 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 14 Nov 2024.