Different Modes of Isotonic Exercises for Knee Osteoarthritis

Effect of Different Modes of Isotonic Exercises on Clinical Outcomes and Cartilage Biomarkers in Knee Osteoarthritis

This is a randomized controlled trial examining and compare the effects of open and closed kinetic chain exercises on pain, function, and cartilage synthesis and degradation biomarkers after an eight-week rehabilitation program for knee osteoarthritis (OA) patients.

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Procedure: Standard physical Therapy; Procedure: Open Kinetic Chain; Procedure: Closed Kinetic Chain

Detailed Description

Design and Subjects: A prospective, active control, three-parallel-group, assessor-blinded, randomized controlled trial. A sample of 120 subjects will be recruited and randomly assigned to one of three study groups at a 1:1:1 allocation ratio (40 participants per group): a) Standard care only, b) Closed kinetic chain exercises plus standard care, and c) Open kinetic chain plus standard care.

Intervention: participants will receive 24 treatment sessions (3 sessions/week) over 8 weeks. Participants will be allocated to the experimental groups will receive the standard care protocol in addition to either closed or open-chain exercises.

Outcome measures: The primary outcomes are physical function and pain assessed using the Western Ontario and McMaster Universities (WOMAC) scores. Secondary outcomes include the Numeric Pain Rating Scale, quadriceps and hamstring strength, joint range of motion (ROM), joint proprioception error, and serum and urine OA biomarkers including the Serum cartilage oligomeric matrix protein (COMP), Serum propeptide Type-II N-terminal (PIIANP), Serum C- reactive protein (CRP), and Urine type -II Collagen telopeptide (CTX-II).

Data Analysis: Data will be analyzed using the intension-to-treat (ITT) analysis with multiple imputations. The primary analysis of the primary outcomes at a two-month follow-up time point (after completing the intervention protocol for 8 weeks) will be carried out using a mixed-model analysis of variance (ANOVA) test with adjustment for a set of pre-specified baseline factors. Secondary analysis using the ANOVA test for the primary outcomes at a six-month follow-up time point, and secondary outcomes at all follow-up time points will also be carried out.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Farrag, PhD; Phone Number: 6941 +966 38440000; Email: afarrag@psmchs.edu.sa

Study Locations

• Saudi Arabia
  • Dammam, Saudi Arabia
    • Recruiting
    • King Fahd Military Medical Complex
    • Contact: Ahmed Farrag

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥40 years of age;
• having knee pain;
• having at least three of the following additional symptoms: a-morning stiffness ≤ 30 minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable warmth;
• willing to provide informed consent

Exclusion Criteria:

• Knee joints showing Kellgren and Lawrence (K-L) grades 1 or 4;
• rheumatoid arthritis;
• serious pathological conditions (inflammatory arthritis and malignancy); total or partial arthroplasty of the affected knee joint, or on a waiting list for joint replacement surgery;
• recent surgical procedure of the lower extremities in the previous 6 months;
• uncontrolled hypertension and unstable cardiovascular problems that could subject the participant to increased risk with exercise and physical exertion;
• physical incapability to safely perform exercises, walking or stationary cycling, as in debilitating visual defects, neurological problems, exaggerated low back pain, advanced osteoporosis, and inability to walk 10 meters without an assistive device;
• use of prescribed analgesics, corticosteroid or analgesic injection intervention for knee pain within the previous 30 days;
• lack of clear comprehension of study procedures or inability to comply with instructions;
• stated inability to attend or complete the proposed course of intervention and follow-up schedule.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Physical Therapy; Control group for the study.	Procedure: Standard physical Therapy; Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), muscle stretching, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
Experimental: Open Kinetic Chain; Standard care in addition to open kinetic chain exercises for the knee joint muscles.	Procedure: Open Kinetic Chain; Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of Quadriceps seated strengthening and Hamstring curl-up exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
Experimental: Closed Kinetic Chain; Standard care in addition to closed kinetic chain exercises for the knee joint muscles.	Procedure: Closed Kinetic Chain; Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of seated leg press and partial squat exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index	A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.	Baseline, 2, and 6 months follow-up
Change in function score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index	A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.	Baseline, 2, and 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)	A horizontal 11-point scale (0-10), with 0 indicating no pain and 10 indicating the worst pain ever.	Baseline, 2, and 6 months follow-up
Change in isometric muscle strength	Measured in Newtons for the Quadriceps and Hamstring muscles using a hand-held dynamometer (Commander Muscle testing, JTech, USA). The greater the recorded value the better the muscle strength.	Baseline, 2, and 6 months follow-up
Change in knee joint range of motion (ROM)	Active knee joint flexion/extension ROM measured in degrees using an electric goniometer (Biometrics Ltd, DLK900, UK). The greater the recorded value the greater the knee joint ROM.	Baseline, 2, and 6 months follow-up
Change in knee joint proprioception	Active repositioning error of a given passive position of the knee joint will be assessed using an electric goniometer (Biometrics Ltd, DLK900, UK). The lesser the recorded value the better the knee joint proprioception.	Baseline, 2, and 6 months follow-up
Change in knee OA biomarkers	Serum (10 ml blood) and urine samples will be collected from the participants and analyzed using the Enzyme-linked immunosorbent assay (ELISA) technique.	Baseline, 2, and 6 months follow-up

Collaborators and Investigators

• Sponsor: Prince Sultan Military College of Health Sciences
• Collaborators: King Fahd Military Medical Complex
• Investigators: Principal Investigator: Ahmed Farrag, PhD, Prince Sultan Military College of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (Actual): June 1, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Osteoarthritis; Knee; Biomarkers; Kinetic exercises
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HAP-05-D-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No