The ACT-ON: A Geriatric 5-Ms-Guided Physical Therapy Intervention for Knee Osteo-Arthritis in Older Adults.
NCT07640529 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-06-10
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
Interventions
- 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
-
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.
Sponsors & Collaborators
-
Qassim University
collaborator OTHER -
King Saud University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-05-15
- Primary Completion
- 2026-09-15
- Completion
- 2026-10-15
Countries
- Saudi Arabia
Study Locations
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