An Evaluation of the Graded Weight-bearing Exercise in Patients With Knee Osteoarthritis.

NCT05671146 | Completed DMC

• 1 other identifier: IRB-PGS-2022-03-447
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Knee osteoarthritis is the most common disorder impacting the synovial joint. The prevalence of osteoarthritis rises with age, and its consequences on health and socioeconomic are significant, which emphasize the need for clinical and cost-effective treatments for patients with knee OA. Knee OA is a widespread joint arthritis disease combined with many clinical features such as pain, decreased joint proprioception and might lead to loss of function and disability. Aim: To evaluate the effect of a 6-weeks supervised graded weight-bearing exercise program on pain, function, proprioception, muscle strength in patients with knee osteoarthritis. Material and Method: Thirty-six patients with chronic knee osteoarthritis with age ranging 40-60 years will be recruited from the physical therapy department and randomized into three groups. Group I: will receive graded weight-bearing exercise using the anti-gravity treadmill combined with open kinetic chain exercises. Group II will receive closed kinetic chain exercises with open kinetic chain exercises while group III will receive open kinetic chain exercises only i.e: stretching and strengthening exercises. The outcome measures will be pain, function, proprioception, and muscle strength. Statistical analysis: To detect changes in the dependent variables within and between groups, one-way repeated measures Multivariate analysis will be applied. If there is a significant change within groups or between tests, the post hoc Bonferroni test will be used to detect the significance between each group and/or each level of measurement. The level of significance is p\<0.05 and confidence interval CI 95%. Study Design: Single-blinded, randomised control trial.

Conditions

Knee Osteoarthritis

Keywords

Graded weight-bearing exercise; Anti-gravity treadmill

Outcome Measures

Primary Outcomes (2)

• Measurment of pain intensity

  The pain will be measured using a visual analogue scale (VAS). This scale is a 10-centimeter drawn line. Zero indicates no pain or discomfort, and 10 indicates the most severe pain. The patient will be asked to mark on the line corresponding to their pain level. For patients with chronic musculoskeletal pain, the VAS is a valid and reliable measure.

  Change from Baseline Pain Intensity at 6 weeks post-intervention

• Function

  The function will be measured by WOMAC. The WOMAC index is a sensitive, validated, and reliable measure of knee osteoarthritis impacts such as functional conditions. The WOMAC scale has 17 items used to assess patients with osteoarthritis physical function. The patient's response runs from 1 to 5, with 1 indicating no response and 5 indicating a strong response. The total score will be calculated by adding the scores for each item.

  Change from Baseline Functional level at 6 weeks post-intervention

Secondary Outcomes (2)

• Proprioception

  Change from Baseline Knee Joint Proprioception at 6 weeks post-intervention

• Muscle strength

  Change from Baseline Quadriceps Muscles strength at 6 weeks post-intervention

Study Arms (3)

Graded weight-bearing exercise

EXPERIMENTAL

participants will perform exercises using an anti-gravity treadmill

Device: anti-gravity treadmill

Closed kinetic chain exercise

ACTIVE COMPARATOR

Exercises will be achieved in a weight-bearing position, with or without support, besides other exercises to improve knee flexors and extensors strength.

Other: Weight-bearing exercises for knee flexors and extensors

open kinetic chain exercise

SHAM COMPARATOR

Exercises including stretching and strengthening exercises for knee flexors and extensors

Other: Non weight-bearing exercises for knee flexors and extensors

Interventions

anti-gravity treadmill DEVICE

participants will perform exercises with partial weight-bearing by using an anti-gravity treadmill

Graded weight-bearing exercise

Weight-bearing exercises for knee flexors and extensors OTHER

Stretching and strengthening exercises will be performed in a weight-bearing position

Closed kinetic chain exercise

Non weight-bearing exercises for knee flexors and extensors OTHER

Stretching and strengthening exercises will be performed in a non-weight-bearing position

open kinetic chain exercise

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients had chronic pain in either unilateral or bilateral knees ≥ 6 months.
• The x-ray showed grades II and III according to on Kallgren and Lawrence (K/L) grading system.
• Patients are willing to stop medications.
• Patients accepted to assign informed consent to participate in the current study and will attend the lab twice a week for six successive weeks.

You may not qualify if:

• They have any known significant medical conditions such as hypertension, asthma, cardiac disease, or systemic disease that adversely affect them during testing.
• Previous knee surgery/injection for the last six months.
• Previous knee fracture or malignancy.
• Unable to walk unaided.
• Unable to commit study requirements.

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University: lead
• Umm Al-Qura University: collaborator

Study Sites (1)

Umm Al-Qura University

Mecca, Western Chapter, 21955, Saudi Arabia

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Ammar S Fadil, Ph.D

  Imam Abdulrahman Bin Faisal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: knee osteoarthritis
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 4, 2023
• Study Start: December 25, 2022
• Primary Completion: March 28, 2023
• Study Completion: July 10, 2023
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)