Effects of Core Stabilization Exercises Versus Foot-Ankle Strengthening Program in Patients With Knee Osteoarthritis.

NCT06658249 | Recruiting

• 1 other identifier: REC/RCR & AHS/24/0132
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis (OA)

Keywords

Knee Osteoarthritis; Pain; Physical Function; Quality of Life

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  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.

  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.

  6 weeks

Study Arms (2)

Core Stabilization Exercises with Foot-Ankle Strengthening Program

EXPERIMENTAL

Core Stabilization Exercises with Foot-Ankle Strengthening Program along with simple conventional treatment.

Other: Core Stabilization Exercises with Foot-Ankle Strengthening Program

Foot-Ankle Strengthening Program

ACTIVE COMPARATOR

Foot-Ankle Strengthening Program along with simple conventional treatment

Other: Foot-Ankle Strengthening Program

Interventions

Core Stabilization Exercises with Foot-Ankle Strengthening Program OTHER

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.

Also known as: Simple Conventional Treatment

Core Stabilization Exercises with Foot-Ankle Strengthening Program

Foot-Ankle Strengthening Program OTHER

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.

Also known as: Simple Conventional Treatment

Foot-Ankle Strengthening Program

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Fatima Memorial Hospital Physical Therapy Department

Lahore, Punjab Province, 25000, Pakistan

RECRUITING

Related Publications (4)

• 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.

  PMID: 37684597 BACKGROUND

• 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.

  PMID: 32179197 BACKGROUND

• 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.

  PMID: 31733777 BACKGROUND

• 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.

  PMID: 37675071 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ali Raza, MS-OMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125; Imran.amjad@riphah.edu.pk

Imran Amjad, Phd

CONTACT

051-5481826; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: October 26, 2024
• Study Start: January 4, 2024
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)