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

NCT07640529 | Not Yet Recruiting DMC

• 1 other identifier: E-25-10322
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rehabilitation; Excercise; Geriatric; Physical Therapy; Rehabilitation Exercise; Rehabilitation Outcome; Knee Osteoarthristis; Knee Osteoarthritis

Keywords

5Ms; PT; KOA; OA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Mini-Cog

  From enrollment till 8weeks

• Stay independent brochure

  At the baseline and will be in 4th and 8th week of intervention

• Timed up and go (TUG)

  Enrollment till 8week

• 2-Minute walk test

  Enrollment till8 weeks

• 5 Time set to stand test

  Enrollment till 8weeks

Study Arms (2)

5Ms-guided physical therapy

EXPERIMENTAL

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; Other: Exercises PT

Standard impairment-based physical therapy

ACTIVE COMPARATOR

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

Interventions

Geriatric 5Ms framework OTHER

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.

Also known as: 5Ms guided Exercise

5Ms-guided physical therapy

Exercises PT OTHER

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.

Also known as: Exercises

5Ms-guided physical therapy; Standard impairment-based physical therapy

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead
• Qassim University: collaborator

Study Sites (1)

King Saud university

Riyadh, Riyadh Region, Saudi Arabia

Location

Related Publications (17)

• 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.

  PMID: 37410384 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 39723744 BACKGROUND

• 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.

  PMID: 36113362 BACKGROUND

• 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.

  PMID: 27449399 BACKGROUND

• 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.

  PMID: 33836697 BACKGROUND

• 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.

  PMID: 30201221 BACKGROUND

• 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.

  PMID: 29763420 BACKGROUND

• 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.

  PMID: 35410675 BACKGROUND

• 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.

  PMID: 25819581 BACKGROUND

• 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.

  PMID: 23973124 BACKGROUND

• 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.

  PMID: 26872913 BACKGROUND

• 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.

  PMID: 24553908 BACKGROUND

• 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.

  PMID: 25865392 BACKGROUND

• 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.

  PMID: 28586122 BACKGROUND

• 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.

  BACKGROUND

• Tinetti, M., How focusing on what matters simplifies complex care for older adults. Institute for Healthcare Improvement Blog. January, 2019. 23.

  BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Bashayer Soliman Alrasheedi, DPT

CONTACT

0559566449; Beshobb42@gmail.com

Maha Mohammad Almarwani, Assistant professor,

CONTACT

0118058400; malmarwani@ksu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of physical therapy

Model Details: The process of screening, recruitment, and randomization (group allocation) of participants will be performed by a therapist who was not involved in the intervention or outcome assessment. Eligible participants (n = 40) are all randomized in a 1:1 allocation ratio to one of the two intervention groups (experimental or control) using a computer-generated randomization table. All participants have to sign an informed consent form after receiving verbal and written information on the study protocol.

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 10, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)