The ACT-ON: A Geriatric 5-Ms-Guided Physical Therapy Intervention for Knee Osteo-Arthritis in Older Adults. (5Ms/PT/KOA/OA)

The ACT-ON: A Geriatric 5-Ms-Guided Physical Therapy Intervention for Knee Osteo-Arthritis in Older Adults: A Randomised Control Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Knee Osteoarthritis; Rehabilitation; Physical Therapy; Geriatric; Excercise; Rehabilitation Outcome; Knee Osteoarthristis; Rehabilitation Exercise
• Intervention / Treatment: Other: Geriatric 5Ms framework; Other: Exercises PT

Detailed Description

Knee osteoarthritis (OA) is a leading cause of disability in midlife and older adulthood, representing a quintessential geriatric condition characterized by multi-complexity. Its management extends beyond impaired mobility to significantly impact mentation, medication use, and overall quality of life. While he 21st century is characterized by a profound global demographic shift towards an older population. While a testament to public health advances, this aging trend precipitates a surge in the prevalence of chronic, debilitating conditions. Among these, knee osteoarthritis (OA) stands as a leading cause of musculoskeletal pain, functional limitation, and diminished quality of life worldwide. The substantial and rising burden of knee OA, both globally and in regions like Saudi Arabia. The burden is not only clinical but also socioeconomic, contributing significantly to healthcare costs, caregiver strain, and loss of independence. Underscores the urgent need for effective, person-centered care models that can address the complex needs of older adults. In response to this challenge, the geriatric community established the "5Ms" framework (encompassing What Matters, Medication, Mentation, Mobility, and Multi-complexity) to provide a holistic, evidence-based model for care. To operationalize this framework specifically for rehabilitation, the Academy of Geriatric Physical Therapy developed "Guiding Principles for Best Practices". For physical therapists, the 5Ms framework is instrumental in delivering this holistic care. While Mobility is a primary focus, effective intervention requires integrating all components: addressing Mentation (e.g., using exercise to manage depression), reviewing Medications that may impact balance or pain, and navigating the patient's Multi - complexity. Crucially, all care is centered on "What Matters Most" to the patient, ensuring interventions are meaningful and lead to improved outcomes. the Geriatric 5Ms framework provides a vital, person-centered structure for holistic geriatric care, aligning interventions with patient goals while navigating medical complexities. a clear gap exists in its systematic application within physical therapy (PT). Standard PT often prioritizes predominantly on the "Mobility" domain, potentially overlooking the critical interplay of other factors that influence patient outcomes. Therefore, the significance of this study lies in its effort to bridge this gap by translating the comprehensive 5Ms model into an actionable, PT-specific protocol the "Act on Program" thereby testing a more integrated and patient-centered approach to a pervasive health problem. This randomized controlled trial will test this more integrated approach to a pervasive health problem, addressing a critical evidence gap, as no prior RCTs have tested the application of the 5Ms framework in physical therapy for knee OA.

Details of all outcome measures (Stay Independent Brochure, Icon-FES, TUG, 2MWT, 5xSTS, ASES-8, PSFS, and MedRisk) were provided, including the purpose of each scale and the domain it assesses.

The outcome measures used in this study include both performance-based and patient-reported tools, each assessing a specific domain relevant to older adults with knee osteoarthritis. The Stay Independent Brochure is used as an educational and fall-risk awareness tool to identify fall-related concerns. The Iconographical Falls Efficacy Scale (Icon-FES) assesses concern about falling during daily activities. Functional mobility and physical performance are evaluated using the Timed Up and Go (TUG), 2-Minute Walk Test (2MWT), and Five-Times Sit-to-Stand Test (5xSTS), which measure balance, walking endurance, and lower-limb strength, respectively. The Arthritis Self-Efficacy Scale-8 (ASES-8) measures confidence in managing arthritis-related symptoms. The Patient-Specific Functional Scale (PSFS) captures patient-identified functional limitations and goals, while the MedRisk questionnaire assesses patient satisfaction with physical therapy services.

These measures assess distinct, non-overlapping constructs aligned with the Geriatric 5Ms framework and cannot be adequately captured by one or two tools alone. All instruments are brief, validated for older adults, and feasible to administer within a one-hour assessment session with rest breaks.

Data related to the Mind domain will be obtained through brief cognitive screening using the Mini-Cog and observation of participant performance during dual-task activities. Mobility data will be collected using standardized gait, balance, and fall-prevention exercises and functional performance tests administered by the physical therapist, including the Five-Times Sit-to-Stand Test (5xSTS), 2-Minute Walk Test (2MWT), and KOS-ADLS. Information regarding Medications will be obtained through participant self-report and review of current medication use, with attention to potential mobility-related side effects; any concerns will be referred to the treating physician when appropriate. Multi-complexity data will be gathered through review of medical history and observation of participant response to exercise, allowing the intervention to be adapted to comorbid conditions. Matters Most data will be obtained through structured patient interviews and goal-setting using participant-identified functional priorities (PSFS), with the Arthritis Self-Efficacy Scale-8 (ASES-8) used to assess confidence in managing arthritis-related goals.

The intervention of 5MS during the session was explain in the procedure section of the form. About utilization of the 5 domains in study from side of physical therapy (Mind 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 intervention. A combined model integrating high-intensity resistance training with neuromuscular exercises is recommended to synergistically target muscle capacity and dynamic joint control. High-intensity training is a viable and effective option for a specific patient subset: those with mild-to-moderate disease (Kellgren-Lawrence grade ≤ III), a BMI < 30, and no severe cardiovascular comorbidities. Such progressive regimens must be initiated under supervision before transitioning to home training.

Medications will be considered through participant self-report of current medication use and any perceived mobility-related side effects, solely to inform exercise monitoring and safety; no medication advice will be provided, and concerns will be referred to the treating physician.: Physical therapists must systematically monitor medication-related effects through weekly check-ins, specifically asking: "Have there been any changes to your medications? How is the pain medication working for you?" This includes conducting a structured interview to document all prescription medications, over-the-counter drugs (especially NSAIDs), and supplements. Particular attention should be paid to analgesics (type, dosage, frequency, and effectiveness), polypharmacy (flagging patients taking ≥5 medications), and high-risk medications (screening for long-term/high-dose NSAID use in patients with comorbidities). Poor pain control or adverse effects should be reported to the referring physician.

Multi-complexity will be addressed by adapting exercises based on comorbidities, pain, fatigue, and functional tolerance. Physical therapists must systematically account for multi-complexity by documenting all comorbidities using a tailored Comorbidity Checklist and conducting brief nutritional screening. This documentation serves not for exclusion but for customizing exercise prescriptions, with continual monitoring of vital signs and specific inquiries about condition management (e.g., "How is your blood sugar control?"). Clinical reasoning focuses on how each condition modifies exercise priorities and risks, such as emphasizing balance training for diabetic neuropathy or adjusting intensity for cardiovascular limitations

Matters Most will guide shared goal setting, with therapy tailored to participant-identified functional priorities. The exercise program must be directly related to the patient's most valued life activities. This is established through a semi-structured interview using the Patient-Specific Functional Scale (PSFS), where the clinician asks: "What three activities are most important to you but are difficult or impossible to do because of your knee problem?", creating patient-centered goals for the entire intervention. These goals should be reviewed at the start of each session to track progress toward what matters most to the patient.

The research team acknowledges the concern regarding the number of outcome measures and the estimated completion time. All selected questionnaires and performance-based tests are brief, validated instruments commonly used in older adult and knee osteoarthritis research. The total assessment time has been carefully piloted and remains within the proposed one-hour session, with scheduled rest breaks and flexibility to pause or reschedule testing if fatigue occurs. Questionnaires will be administered in an assisted, interviewer-led format to reduce participant burden and improve completion efficiency. In addition, outcome measures are administered only at two time points (baseline and post-intervention). To further ensure feasibility, primary outcome measures will be prioritized, and secondary measures will be omitted if participant tolerance is exceeded, without compromising participant safety or study integrity.

A fully scripted session-by-session intervention manual will not be used. Instead, both groups will receive standardized, guideline-based intervention protocols with clearly defined core components, progression principles, safety parameters, and allowable individualization. This approach reflects real-world physical therapy practice while ensuring consistency and treatment fidelity across participants.

Control group (Standard impairment-based physical therapy):

Participants will receive a structured impairment-based physical therapy program aligned with current clinical practice guidelines for knee osteoarthritis. Core components will include lower-limb strengthening (quadriceps, hamstrings, hip abductors), aerobic conditioning (e.g., walking or stationary cycling), flexibility, balance, range of motion, gait training, and standardized biomedical education addressing osteoarthritis self-management (weight management, joint protection, knee anatomy and biomechanics, and tissue healing timelines). Exercise intensity and progression will follow established principles of progressive overload and American College of Sports Medicine (ACSM) guidelines, progressing from low to moderate intensity based on participant tolerance and safety.

Experimental group (5Ms-guided physical therapy):

Participants in the experimental group will receive all components of the standard physical therapy program. In addition, treatment will be systematically guided by the Geriatric 5Ms framework (What Matters Most, Medications, Mind, Mobility, and Multi-complexity).

What Matters Most: Shared goal setting using the Patient-Specific Functional Scale to align exercises with patient-prioritized activities.

Mobility: Emphasis on individualized gait, balance, strengthening, functional training, and fall-prevention strategies, with progressive exercise prescription.

Mind: Baseline cognitive screening and ongoing monitoring during therapy activities to ensure safety and appropriate task demands.

Medications: Weekly monitoring of self-reported medication use and side effects solely to inform exercise safety, with referral to physicians when concerns arise.

Multi-complexity: Adaptation of exercise prescription based on comorbidities, fatigue, pain, and functional tolerance, with ongoing clinical monitoring.

Intervention delivery and fidelity:

All interventions will be delivered by licensed physical therapists following predefined treatment domains, progression criteria, and safety rules. Individualization will be permitted within these boundaries to account for patient tolerance and clinical presentation, without altering the core structure of the intervention. This approach ensures feasibility, safety, and consistency across the 16 sessions for both groups.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bashayer Soliman Alrasheedi, DPT; Phone Number: 0559566449; Email: Beshobb42@gmail.com
• Study Contact Backup: Name: Maha Mohammad Almarwani, Assistant professor,; Phone Number: 0118058400; Email: malmarwani@ksu.edu.sa

Study Locations

• Saudi Arabia
  • Riyadh Region
    • Riyadh, Riyadh Region, Saudi Arabia
      • King Saud university
      • Contact: Maha Mohammed Almarwani, Assistant professor; Phone Number: 0118058400; Email: malmarwani@ksu.edu.sa
      • Contact: walid M Alkeridy, Assistant professor; Phone Number: 0556933339; Email: walkeridy@ksu.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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
• self-report the ability to tolerate a one-hour assessment session.

Exclusion Criteria:

• 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).
• severe joint instability or deformity.
• unmanaged severe osteoporosis.
• a recent intra-articular corticosteroid injection (<3 months).
• active cancer treatment within the past 6 months.
• non-elective hospitalization for a major illness.
• surgery within the past 6 months.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5Ms-guided physical therapy; Participants in the experimental group will receive all components of the standard physical therapy program. In addition, treatment will be systematically guided by the Geriatric 5Ms framework (What Matters Most, Medications, Mind, Mobility, and Multi-complexity). What Matters Most: Shared goal setting using the Patient-Specific Functional Scale to align exercises with patient-prioritized activities. Mobility: Emphasis on individualized gait, balance, strengthening, functional training, and fall-prevention strategies, with progressive exercise prescription. Mind: Baseline cognitive screening and ongoing monitoring during therapy activities to ensure safety and appropriate task demands. Medications: Weekly monitoring of self-reported medication use and side effects solely to inform exercise safety, with referral to physicians when concerns arise. Multi-complexity: Adaptation of exercise prescription based on comorbidities, fatigue, pain, and functional tolerance, with ongoing clinicalM	Other: Geriatric 5Ms framework; Mind 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.; Other Names: 5Ms guided Exercise; Other: Exercises PT; This 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.; Other Names: Exercises
Active Comparator: Standard impairment-based physical therapy; Participants will receive a structured impairment-based physical therapy program aligned with current clinical practice guidelines for knee osteoarthritis. Core components will include lower-limb strengthening (quadriceps, hamstrings, hip abductors), aerobic conditioning (e.g., walking or stationary cycling), flexibility, balance, range of motion, gait training, and standardized biomedical education addressing osteoarthritis self-management (weight management, joint protection, knee anatomy and biomechanics, and tissue healing timelines). Exercise intensity and progression will follow established principles of progressive overload and American College of Sports Medicine (ACSM) guidelines, progressing from low to moderate intensity based on participant tolerance and safety.	Other: Exercises PT; This 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.; Other Names: Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Showed high responsiveness to clinical change, with a large effect size (1.12) and a minimum clinically important difference (MCID) of 14 points and the minimal detectable change (MDC) is 7.43 points over a 4-week period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment till 8weeks
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	At the baseline and will be in 4th and 8th week of intervention
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	Enrollment till 8week
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.	Enrollment till8 weeks
5 Time set to stand test	Participants will begin in a standardized seated position with armless chair (seat height 43 cm). The starting posture with the back upright against the chair, hips at 90° of flexion, arms crossed over the chest, and feet positioned with heels 10 cm posterior to the knees. Participants will instruct to complete five full standing and sitting cycles as quickly as possible while maintaining safety. The time, in seconds, was recorded from the verbal cue "go" until the participant's back rest on the backrest upon completion of the fifth repetition. The mean time of three trials was calculated [49, 50]. The 30-second and 5-time sit-to-stand (STS) tests exhibited excellent intra-rater (ICC = 0.990-1.000), inter-rater (ICC = 0.996-0.999), and test-retest (ICC = 0.841-0.853) reliability. Despite high reliability, A minimal detectable change (MDC) of 3.54 in 30-second STS and 7.48 in 5-time STS.	Enrollment till 8weeks
Patient-specific functional scale (PSFS)	The patients will be asked to record up to five important functional activities that they have difficulties with because of their condition. Then, each of the activity limitations will be rate recorded on an 11-point scale, where 0 represents unable to perform the activity and 10 represents able to perform an activity at the same level as before the condition. To calculate the total score, the sum of the activity scores was divided by the number of activities recorded. A higher score indicates higher functional ability (appendix J) [56]. The Arabic PSFS had very good test-retest reliability (ICC = 0.86) with no floor or ceiling issues. The standard error of measurement and the minimal detectable change of the Arabic PSFS were 0.64 and 1.49 points respectively indicating acceptable measurement error. The majority of the predefined construct validity hypotheses (75%) were supported by the results justifying the construct validity of the Arabic PSFS with Patients with lower extremity M	Enrollment till 8weeks
Patient satisfaction level with physical therapy service Med-Risk	Patient satisfaction will be measured using the Arabic version of the med risk Instrument for Measuring Patient Satisfaction (MRPS-AR). This validated tool assesses satisfaction with physical therapy services through e has a 2-factor structure: 10 specific items ''internal,'' relating to the patient-therapist interaction (items 4-10), and ''external,'' (items 1-3). 2 global Items 11 and 12 are global measures of satisfaction describing non-therapist issues such as admissions and clinic environment. Instrument Respondents rate their agreement with each statement on a 5-point Likert scale, from "completely disagree" to "completely agree". The total score of the questionnaire ranges from 20 to 100. A higher score indicates more satisfaction and vice versa (appendix L)[61].The instrument has demonstrated acceptable to high internal consistency (Cronbach's α = 0.819-0.936) and excellent test-retest reliability (ICC = 0.965-0.983). Convergent validity was demonstrated by global rating.	In enrollment and after 8weeks
Iconographical falls efficacy scale (icon-FES)	The (Icon-FES) will be used to assess fear of falling. This 10-item, interview-based tool utilizes pictorial representations of daily activities to evaluate an individual's confidence in performing them without falling. Participants rate their concern for each activity on a 4-point scale (1 = not at all concerned to 4 = very concerned). Total scores range from 10 to 40, with higher scores (19-40) indicating greater concern (appendix H) [42]. The Arabic version used in this study has demonstrated excellent psychometric properties, including high internal consistency (α=0.95), test-retest reliability (ICC=0.97), and strong convergent validity with the Arabic FIS-I (rₛ=0.73, p<0.001) [43]	Enrollment and after 8weeks

Collaborators and Investigators

• Sponsor: King Saud University
• Collaborators: Qassim University

Publications and helpful links

General Publications

• Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, Bridgett L, Williams S, Guillemin F, Hill CL, Laslett LL, Jones G, Cicuttini F, Osborne R, Vos T, Buchbinder R, Woolf A, March L. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014 Jul;73(7):1323-30. doi: 10.1136/annrheumdis-2013-204763. Epub 2014 Feb 19.
• Kohn MD, Sassoon AA, Fernando ND. Classifications in Brief: Kellgren-Lawrence Classification of Osteoarthritis. Clin Orthop Relat Res. 2016 Aug;474(8):1886-93. doi: 10.1007/s11999-016-4732-4. Epub 2016 Feb 12. No abstract available.
• Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013 Sep;21(9):1145-53. doi: 10.1016/j.joca.2013.03.018.
• Kraus VB, Blanco FJ, Englund M, Karsdal MA, Lohmander LS. Call for standardized definitions of osteoarthritis and risk stratification for clinical trials and clinical use. Osteoarthritis Cartilage. 2015 Aug;23(8):1233-41. doi: 10.1016/j.joca.2015.03.036. Epub 2015 Apr 9.
• Liu Q, Niu J, Huang J, Ke Y, Tang X, Wu X, Li R, Li H, Zhi X, Wang K, Zhang Y, Lin J. Knee osteoarthritis and all-cause mortality: the Wuchuan Osteoarthritis Study. Osteoarthritis Cartilage. 2015 Jul;23(7):1154-7. doi: 10.1016/j.joca.2015.03.021. Epub 2015 Mar 25.
• Lusardi MM, Hartley GW, Leach SJ, Gras LZ, Larkin M, Miller KL, Quiben M. The Case for Developing a Movement System Framework for Older Adults. Phys Ther. 2023 Oct 3;103(10):pzad079. doi: 10.1093/ptj/pzad079.
• Hartley, G., et al., Integrating The Geriatric 5Ms Into Movement Analysis And Collaborative Geriatric Physical Therapy. Innovation in Aging, 2024. 8(Suppl 1): p. 881.
• Blood KM, Mierzwicki JT, Billek-Sawhney B, Heitzman J, Dehner LR, Dawson N, Hartley GW. Development of the Revised Entry-Level Essential Competencies in the Care of Older Adults: Linking Domains of Competence, Commission on Accreditation in Physical Therapy Education Standards, and the Geriatric 5Ms. J Geriatr Phys Ther. 2025 Oct-Dec 01;48(4):202-209. doi: 10.1519/JPT.0000000000000436. Epub 2025 Oct 17.
• Hutting N, Caneiro JP, Ong'wen OM, Miciak M, Roberts L. Person-centered care for musculoskeletal pain: Putting principles into practice. Musculoskelet Sci Pract. 2022 Dec;62:102663. doi: 10.1016/j.msksp.2022.102663. Epub 2022 Sep 6.
• Kebede S. Ask patients "What matters to you?" rather than "What's the matter?". BMJ. 2016 Jul 22;354:i4045. doi: 10.1136/bmj.i4045. No abstract available.
• Fairley JL, Seneviwickrama M, Yeh S, Anthony S, Chou L, Cicuttini FM, Sullivan K, Briggs AM, Wluka AE. Person-centred care in osteoarthritis and inflammatory arthritis: a scoping review of people's needs outside of healthcare. BMC Musculoskelet Disord. 2021 Apr 9;22(1):341. doi: 10.1186/s12891-021-04190-z.
• Hakansson Eklund J, Holmstrom IK, Kumlin T, Kaminsky E, Skoglund K, Hoglander J, Sundler AJ, Conden E, Summer Meranius M. "Same same or different?" A review of reviews of person-centered and patient-centered care. Patient Educ Couns. 2019 Jan;102(1):3-11. doi: 10.1016/j.pec.2018.08.029. Epub 2018 Aug 26.
• Bindawas SM, Vennu V, Alfhadel S, Al-Otaibi AD, Binnasser AS. Knee pain and health-related quality of life among older patients with different knee osteoarthritis severity in Saudi Arabia. PLoS One. 2018 May 15;13(5):e0196150. doi: 10.1371/journal.pone.0196150. eCollection 2018.
• Hawker GA, King LK. The Burden of Osteoarthritis in Older Adults. Clin Geriatr Med. 2022 May;38(2):181-192. doi: 10.1016/j.cger.2021.11.005.
• Tinetti M, Huang A, Molnar F. The Geriatrics 5M's: A New Way of Communicating What We Do. J Am Geriatr Soc. 2017 Sep;65(9):2115. doi: 10.1111/jgs.14979. Epub 2017 Jun 6. No abstract available.
• Foundation, J.A.H., Age-Friendly Health Systems: Guide to Using the 4Ms in the Care of Older Adults. Institute for Healthcare Improvement Blog. July, 2022.
• Tinetti, M., How focusing on what matters simplifies complex care for older adults. Institute for Healthcare Improvement Blog. January, 2019. 23.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: June 6, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 6, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: KOA; OA; PT; 5Ms
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: E-25-10322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Participant responses collected through Google Forms will be kept confidential. All forms will be linked to coded participant IDs, with no direct personal identifiers included in the form itself. Access to the Google Form and its responses will be restricted to authorized research team members only, protected by secure login credentials. Data will be exported and stored on password-protected institutional computers. Hard copies, if any, will be stored in locked cabinets within restricted-access areas. All results will be reported in aggregate form to prevent individual identification. Participants are informed of these measures in the consent form.

Drug and device information, study documents

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