The ACT-ON: A Geriatric 5-Ms-Guided Physical Therapy Intervention for Knee Osteo-Arthritis in Older Adults: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 55 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Geriatric 5Ms framework (Other)
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
干预措施: Exercises PT (Other)
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.
干预措施: Exercises PT (Other)
研究者
Bashayer soliman alrasheedi
Doctor of physical therapy
King Saud University
