Fooyin University
Kaohsiung City, Taiwan (r.o.c.), 831301, Taiwan
NCT Number: NCT07804212
This study aims to investigate the effectiveness of an intervention combining strength training and self-management education in improving symptoms, sleep quality, emotional well-being, and quality of life in patients with knee osteoarthritis. This study employs a quasi-experimental design. Participants diagnosed with knee osteoarthritis were recruited from the outpatient orthopedics and rehabilitation departments of a public regional teaching hospital in southern Taiwan. They were randomly assigned to either an experimental group (n = 50) or a control group (n = 50). Due to the nature of the intervention, blinding was not feasible, and participants were aware of their group assignment.
The experimental group also participated in a home-based strength training program, while the control group received conventional osteoarthritis routine care. Data were collected at baseline, one month, and three months post-intervention during follow-up appointments.
Trial opening soon.
Get Notified45 year and older
All sexes
Interventional
Not applicable
Kaohsiung City, Taiwan (r.o.c.), 831301, Taiwan
Introduction Osteoarthritis is a chronic, progressive degenerative joint disease that predominantly affects the knee. Common clinical manifestations include joint pain, stiffness, and impaired physical function, which often lead to diminished sleep quality and psychological well-being, ultimately compromising the patient's overall quality of life. Osteoarthritis is a common degenerative disease that predominantly affects patients with Knee Osteoarthritis (KOA). Symptoms include swelling, pain, stiffness, and functional impairment of the lower limb joints. Severe cases can result in muscle atrophy and long-term disability, making it a major global health burden. WHO data indicates that while 365 million people had OA by 2019, the number surged to 528 million by late 2023, marking a 113% increase since 1990. The disease is particularly prevalent in the aging population, affecting 73% of men and 60% of women over the age of 55. Knee OA is the most common subtype, followed by hip OA. In Taiwan, the prevalence rate grew significantly from 7.9% in 1994 to 15% in 2015. Despite the rate remaining steady at 15% through 2024, the absolute number of people suffering from OA pain exceeds 3.5 million and continues to grow, severely impacting their daily quality of life. As the primary weight-bearing joint of the human body, the knee is highly susceptible to osteoarthritis (OA) due to constant mechanical stress and activity. Clinical manifestations typically include joint pain, stiffness, swelling, and impaired physical function. The development of OA is significantly associated with age and gender, particularly among individuals aged 45-50 and older. Given the global trends of population aging and increasing obesity, the impact of OA on physical function and quality of life has become more pronounced, subsequently escalating the socioeconomic burden. Consequently, investigating the symptoms and determinants of knee OA, alongside the current implementation of strength training and self-management interventions, has become a critical area of concern.
Pain symptoms associated with KOA lead to prolonged impairments across physical, psychological, and social domains, which subsequently compromise mental health, sleep quality, and general well-being. NICE (2020) identifies aging, female gender, and obesity as the primary risk factors for joint degeneration. The resulting pain and mobility limitations have enduring effects; persistent joint stiffness and discomfort often lead to a decline in sleep hygiene and psychological health, eventually evolving into chronic conditions that diminish quality of life in later years. Pain in KOA is a complex, subjective experience, and empirical evidence suggests a reciprocal relationship where deteriorating sleep quality is linked to the progressive worsening of arthritic pain. As a form of chronic musculoskeletal pain, it frequently disrupts nocturnal sleep, causing significant disturbances. Specifically, pain prolongs Stage 1 of non-rapid eye movement (NREM) sleep and interrupts the deeper Stages 3-4 (slow-wave sleep), leading to sleep patterns that are characteristically shallow, abbreviated, and fragmented, especially among the elderly population. In addition to pharmacological and surgical interventions, therapies such as acupuncture, Tai Chi, and yoga have been empirically validated for managing the progression and symptom severity of Knee Osteoarthritis (KOA). Significant early evidence indicates that strengthening the knee joint and its surrounding musculature can delay the radiographic progression of degeneration. Consequently, implementing structured and effective exercise regimens for symptom management and rehabilitation is crucial before surgical intervention becomes necessary. Such programs not only alleviate arthritic symptoms but also facilitate the maintenance of optimal sleep quality, mental health, and overall well-being. Defined as a planned, structured, and repetitive form of physical activity designed to enhance or maintain physical fitness, exercise therapy is widely utilized due to its feasibility and cost-effectiveness. Current international clinical guidelines advocate for exercise as a first-line treatment for KOA. The prescription of these exercise programs should be tailored to the specific joint location, pain phenotype, disease severity, comorbidities, and the patient's baseline physical condition. Given the high prevalence of KOA, there is a critical need for accessible and cost-effective strategies; therefore, home-based exercise programs should be prioritized.
In a systematic review and meta-analysis by Guo et al. (2022), 15 clinical trials identified from databases such as PubMed, EBSCO, SportDiscus, Medline, and Web of Science (2000-2022) were analyzed. The findings revealed that structured exercise programs significantly improved pain, stiffness, and physical function in patients with KOA. Similarly, a Cochrane review of 55 studies across five major databases (MEDLINE, EMBASE, CENTRAL, CINAHL, and PEDro) concluded that exercise interventions yield moderate to significant benefits in pain reduction and functional improvement. Resistance training, in particular, has been shown to effectively alleviate pain. However, experts caution that ineffective or improperly supervised exercise regimens may exacerbate symptoms, resulting in poor clinical outcomes and diminished patient adherence; thus, the modality and frequency of exercise must be meticulously designed and managed (Peeler & Ripat, 2018). Despite these global findings, local research in Taiwan concerning the interplay between KOA symptoms, sleep quality, emotional well-being, and the efficacy of strength training and self-management remains sparse.
Study purpose This study aims to evaluate the effectiveness of a combined strength training and self-management intervention in enhancing the symptomatic, psychological, and functional outcomes of patients with knee osteoarthritis.
Study design A quasi-experimental design will be employed in this study to evaluate the effectiveness of the intervention. Data will be gathered through structured questionnaires administered both before and after the strength training program. The assessment will focus on several key variables: osteoarthritis symptoms, sleep quality, emotional well-being, and quality of life. These pre- and post-intervention measures will then be analyzed to determine the impact of the strength training program on the participants. The target population for this study will consist of patients with knee osteoarthritis (KOA). Consecutive sampling will be utilized to recruit participants from the orthopedic and rehabilitation outpatient departments of a public regional teaching hospital in southern Taiwan. Participants will be required to complete basic demographic forms and structured questionnaires both before and after the intervention.
Study Setting, Participants, Sample Size Estimation Inclusion criteria will be as follows: patients aged 45 or older diagnosed with symptomatic KOA by a physician, who are conscious, have normal hearing, and are capable of effective communication. Conversely, the exclusion criteria will include patients with severe inflammatory arthritis; those awaiting or having undergone unilateral or bilateral total knee arthroplasty; individuals with contraindications to exercise therapy; those who have received physical therapist-led exercise therapy or knee injections within the past month; and individuals diagnosed with psychiatric or cognitive impairments. Sample size estimation will be performed using G*Power 3.1.9.4 software, employing the "Means: Difference between two independent means (two groups)" test mode. With the effect size set at a medium level of 0.6, a significance level (alpha) of 0.05, and a power of 0.80 (Cohen, 1988), the analysis indicates a minimum required sample size of 90 participants. Accounting for an estimated attrition rate of 10%, the total sample size will be increased to 100 participants, with 50 individuals assigned to the experimental group and 50 to the control group.
Study Recruitment Process During recruitment at the orthopedic or rehabilitation outpatient departments, the study's objectives and the group assignment process will be explained to potential participants. After obtaining signed informed consent, participants will be randomly assigned to either the experimental or control group using computer-generated randomization. Participants will be aware of their group assignment. Both groups will receive health education through a "Knee Osteoarthritis Self-Management Course" (with an online instructional URL provided for home viewing). The experimental group will additionally receive a "Home-Based Strength Training" intervention, while the control group will maintain conventional routine care. Prior to the intervention, baseline data will be collected from both groups. The demographic data will encompass age, gender, education level, marital status, religious beliefs, occupation, level of social support, smoking and alcohol history, history of knee osteoarthritis and pain, medication history, and comorbidities. The assessment scales will include the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), PSQI, HADS, and the EQ-5D-3L.
Quadriceps Stretch: While standing and holding a stable surface for balance, participants will pull one ankle toward the glutes until tension is felt in the anterior thigh. (Held for 30 seconds, 10 reps per set, 3 times per day).
After the initial demonstration, participants will demonstrate the exercises back to the researcher. The researcher will provide corrections until the movements are performed correctly. Participants will be instructed to record their completion in an exercise log. Follow-up assessments will occur during the second clinic visit (1 month post-intervention) and the third clinic visit (2 months post-intervention), utilizing the WOMAC, PSQI, HADS, and EQ-5D-3L scales. Additionally, the researcher will conduct two telephone follow-ups and home visits as needed during the study period to monitor adherence.
Ethical Considerations
Data Processing and Statistical Analysis The demographic data and questionnaire responses collected in this study will be coded and entered into a computer database. Data management and statistical analysis will be performed using IBM SPSS Statistics version 26.0. The significance level for all statistical analyses is set at alpha = 0.05. In addition to descriptive statistics, the choice between parametric or non-parametric methods for correlational and inferential analyses will be determined after assessing the data distribution. A normality test (e.g., Shapiro-Wilk or Kolmogorov-Smirnov test) will be conducted to confirm whether the collected data follow a normal distribution.
Expected Contributions This study will employ a quasi-experimental design to evaluate the effectiveness of a strength training intervention in alleviating symptoms and improving sleep quality, emotional health, and overall quality of life among patients with knee osteoarthritis. The findings are expected to demonstrate the clinical significance of a feasible, home-based strength training program in reducing symptom severity and enhancing the well-being of KOA patients in Taiwan. Furthermore, the results will be prepared for publication in international peer-reviewed journals to facilitate knowledge dissemination within the global academic community and the general public. Beyond its academic contributions, this study will provide evidence-based insights to help healthcare authorities optimize treatment, care, and management protocols for KOA, ultimately contributing to reduced national healthcare expenditures. Finally, this program empowers patients to proactively self-manage their symptoms and promote long-term functional independence.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A structured home-based strength training program consisting of knee endurance exercises, sit-to-stand transitions, walking, and range-of-motion (ROM) exercises. The intervention is performed three times per week for 8 weeks. To ensure exercise fidelity and safety, the 'teach-back' method is utilized during initial instruction, and participants maintain a daily exercise log to monitor compliance.
Time frame: Baseline, 1 month, and 2 months
The HADS consists of anxiety and depression subscales, each with seven items and a maximum score of 21; higher scores indicate greater symptom severity.
Time frame: Baseline, 1 month, and 2 months
The PSQI comprises seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline, 1 month, and 2 months
EQ-5D-3L comprises two components: (1) the EQ-5D health index. A maximum total score of 15; lower scores indicate better health-related quality of life. (2) EQ-VAS uses a visual analog scale with a maximum score of 100.
Time frame: Baseline, 1 month, and 2 months
WOMAC: The Mandarin Chinese version uses a 100-mm visual analog scale, with ends representing opposite symptoms like "no pain" to "very painful," "no stiffness" to "very stiff," and "no difficulty" to "very difficult." Scores range from 0 to 100 per question, with pain up to 500, stiffness up to 200, and activity up to 1700 points.
Contact information is provided by the study sponsor or research team.
Pingtung Veterans General Hospital
Other Gov
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