Different Modes of Isotonic Exercises for Knee Osteoarthritis

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04909086
Study type	Interventional
Source	Prince Sultan Military College of Health Sciences
Contact	Ahmed Farrag, PhD
Phone	+966 38440000
Email	afarrag@psmchs.edu.sa
Status	Recruiting
Phase	N/A
Start date	August 21, 2021
Completion date	June 2023

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.