The study is a Random control trail study conducted at King Khalid University Hospital in Riyadh, Saudi Arabia, focusing on Application of 5 framework in rehabilitation program of knee arthritis. The study will involve a in each group sample of 20 KOA patients, with a 12-month duration. The sample size was estimated using G\*Power 3.1 software, and the initial power analysis indicated that 40 participants would be required to achieve 80.0% statistical power. The study's participants will be aged between 55 and 80 years, diagnosed with Knee osteoarthritis, without cognitive impairment, knee surgery in the past 6 months, or unstable comorbidities. The study will involve in-person 16 sessions, with the first two lasting approximately one hour and the remaining session 30-45 minutes. The main outcome measures that will be used in this study are Stay Independent Brochure, Iconographical Falls Efficacy Scale (icon-FES), Timed Up and Go, 2-Minute Walk Test, 5 Time Set to Stand Test AND Arthritis Self-Efficacy Scale 8 Item (ASES-8), Patient-Specific Functional Scale (PSFS), and Patient satisfaction level with Physical Therapy service MedRisk. Data will be taken from direct questions to patients, by filling out the questionnaire via Google Form, and through some tests and SPSS will be used for data analysis, with ANOVA Test intervention scores of the outcome measures.
Prospective participants will be Saudi Nationals
aged 60 years or older
with a clinical diagnosis of knee osteoarthritis.
individuals must be capable of walking 10 meters independently or with an assistive device
severe cognitive impairment
knee surgery within the past 6 months.
diagnosis of rheumatoid arthritis
the presence of unstable comorbidities (e.g., uncontrolled hypertension, heart failure, arrhythmia, severe pulmonary disease requiring oxygen, or a cardiac event in the past 6 months).
Parallel
Geriatric 5Ms framework
Other interventionMind will be addressed through brief cognitive screening at baseline and by monitoring performance during simple dual-task activities to support safety. Therapeutic interventions must be tailored to the patient's cognitive capacity, with environmental structuring and guided strategies provided for those with impaired cognition to ensure safe task completion. Mobility will be the primary focus of each session and will include individualized gait training, balance exercises, strengthening, and fall-prevention strategies appropriate for knee osteoarthritis. The exercise program must be explicitly progressive and systematically address strength, range of motion (ROM), and functional mobility. This requires regular screening and examination of gait, balance, transfer ability, and endurance to quantify improvement and guide interventions. A combined model integrating high-intensity resistance training with neuromuscular exercises is recommended to synergistically target muscle capacity.
Exercises PT
Other interventionThis standard protocol will consist of the following core components: strengthening exercises for key lower limb muscle groups (quadriceps, hamstrings, and hip abductors); aerobic conditioning such as walking or stationary cycling; and training focused on flexibility, balance, range of motion, and gait. Additionally, participants will receive standardized biomedical education covering topics essential for osteoarthritis self-management, including weight management, joint protection principles, anatomy and biomechanics of the knee, and tissue healing timelines.
Knee Outcome Survey Activities of daily living scale (KOS-ADLS)
The participant will be administered a knee-specific patient-reported outcome measure is (KOS-ADL) comprising 14 items. It evaluates limitations in daily activities due to knee symptoms (e.g., pain, swelling; 6 items) and difficulty with specific functional tasks (e.g., walking, stair climbing; 8 items). Items are rated on a 6-point Likert scale, and the total score is transformed to a 0-100 scale, where higher scores indicate better functional ability (appendix E).It has demonstrated strong psychometric properties, making it highly suitable for both clinical and research use. This measure demonstrates high responsiveness to change in knee osteoarthritis patients, with an effect size of 1.31 to 4.76 and standardized response mean of 1.64 to 3.18. Confirming its sensitivity in detecting meaningful improvements in knee osteoarthritis patients over 6-12 month longitudinal follow-ups. The Arabic version of (AKOS-ADL) demonstrated excellent reliability, with excellent internal consistency.
Mini-Cog
The Mini-Cog, a brief cognitive assessment tool, will be administered. It consists of a three-word recall test and a clock drawing test (CDT) and requires approximately three minutes to complete. . The Mini-Cog is noted for its high sensitivity (99%) and specificity (93%-96%) in detecting dementia among ethnically and linguistically diverse elderly populations. Key advantages include its brevity, ease of administration and scoring, high acceptability, and its diagnostic value, which is not significantly influenced by education, language, or cultural background. It has also been shown to be more sensitive than the Mini-Mental State Examination (MMSE) in detecting mild dementia \[34\]. The Arabic version of the Mini-Cog is a good screening tool for cognitive impairment showed, good sensitivity (71.4%) and specificity (61.6%) when combined with other cognitive measures, with excellent test-retest reliability with cut-off point 1.5.
Stay independent brochure
The Stay Independent Brochure (SIB), part of the CDC's STEADI initiative, we will be used for fall risk screening. The instrument incorporates a 12-item self-report fall-risk checklist. Each item is dichotomous (yes/no) and is accompanied by a clarifying statement explaining its clinical relevance. Items are weighted, with scores of 0-1 or 0-2 assigned based on the assessed risk factor. The total score is calculated by summing the values of all endorsed items. A pre-established cut-off score of ≥4 points was used to identify individuals at an increased risk of falling, while a score of ≤3 indicated low risk. The AR-SIB were evaluated as a reliable and valid tool to discriminate falls and screen for fall risk among Arabic-speaking community-dwelling older adults. the internal consistency was assessed using the Kuder-Richardson 20 (KR-20) formula with 0.73 and excellent test-retest reliability (ICC2,1=0.96). Convergent validity was tested The AR-SIB showed moderate correlations with TUG
Timed up and go (TUG)
Functional mobility and dynamic balance will be assessed using the Timed Up and Go (TUG) test. Participants will begin seated in a standard-height chair. Upon the examiner's verbal command "go," they stood up, walked for 3 meters at a self-selected comfortable pace, turned around, walked back to the chair, and sat down. Timing will stop at the moment the participant's back to the chair's backrest. The time will be taken to complete the task is recorded in seconds. The average time from two consecutive trials was calculated and used for subsequent analysis \[44\]. A TUG score of ≥12 sec identifies older adults as at higher risk of falls \[45\]. The TUG was demonstrating good correlation with patient-reported outcomes and sensitivity to change over 6-24 month follow-up period
2-Minute walk test
The 2-Minute Walk Test (2MWT) is a recommended tool for assessing walking capacity in patients with knee osteoarthritis (KOA). Demonstrated excellent test-retest reliability, with an Intraclass Correlation Coefficient (ICC) of 0.98 with statistically significant mean difference of 2.36 ± 2.74 meters (p \< 0.001). The measurement precision was high, with a Standard Error of Measurement (SEM) of 2.76 meters and a Minimal Detectable Change at a 95% confidence level (MDC₉₅) of 5.52 meters \[47\]. Participants will perform the walk test on a designated 30-meter course. The pathway will be in straight line with cones place at each end to delineate the turning points. Standardized verbal instructions were given to walk at a self-selected, The 2-Minute Walk Test (2MWT) provides a validated measure of functional endurance in knee osteoarthritis patients suitable for longitudinal monitoring over extended periods.
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King Saud University
Lead sponsor
Qassim University
Collaborator
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