Clinical trial NCT06658249: Effects of Core Stabilization Exercises Versus Foot-Ankle Strengthening Program in Patients With Knee Osteoarthritis.
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis (OA)
Keywords: Knee Osteoarthritis
Pain
Physical Function
Quality of Life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-26
Enrollment: 46
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 6 weeks
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire
timeFrame: 6 weeks
measure: WESTREN ONTARIO AND MCMASTER UNIVERSITIES OSTEOARTHRITIS INDEX (WOMAC SCALE)
timeFrame: 6 weeks
measure: 36- Items Short Form Survey (SF-36) QUESTIONNAIRE
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Fatima Memorial Hospital Physical Therapy Department
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ali Raza, MS-OMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Holm 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.
citation: Hernandez 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.
citation: GBD 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.