The ACT-ON: A Geriatric 5-Ms-Guided Physical Therapy Intervention for Knee Osteo-Arthritis in Older Adults.
Key facts
- Who runs it
- King Saud University
- Where
- Saudi Arabia1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Not yet recruiting
- People taking part
- 40 people, planned
- Starts
- 15 Nov 2026
- Expected to end
- 15 Oct 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Geriatric 5Ms framework
- Exercises PT
- Record updated
- 31 August 2026
Who can take part
- Age
- 55 years to 90 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- knee surgery within the past 6 months
- a recent intra-articular corticosteroid injection (<3 months)
- surgery within the past 6 months
- severe cognitive impairment
- 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)
- active cancer treatment within the past 6 months
- non-elective hospitalization for a major illness
- diagnosis of rheumatoid arthritis
- severe joint instability or deformity
- unmanaged severe osteoporosis
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 55 and 90 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- 5Ms-guided physical therapyTreatment being tested
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
Treatment: Geriatric 5Ms framework and Exercises PT
- Standard impairment-based physical therapyExisting treatment, for comparison
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.
Treatment: Exercises PT
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The ACT-ON: A Geriatric 5-Ms-Guided Physical Therapy Intervention for Knee Osteo-Arthritis in Older Adults: A Randomised Control Trial
- Fit questions
- Built from NCT07640529, who can take part
- Record updated
- 31 August 2026