About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 45 or older
Diagnosed with symptomatic knee osteoarthritis by a physician
Normal hearing and able to communicate effectively
Disqualifiers
Severe inflammatory arthritis
Pending or previous unilateral or bilateral total knee replacement
Contraindications to exercise therapy
Received physical therapy or knee injections in the past month
Trial design
Parallel
Treatments tested in this trial
Strength Training
Other interventionA 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.
Treatment groups
Trial outcomes
Primary outcomes
Emotional well-being measured by the HADS
The HADS consists of anxiety and depression subscales, each with seven items and a maximum score of 21; higher scores indicate greater symptom severity.
Sleep quality measured by the PSQ
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.
Quality of life measured by the EQ-5D-3L
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.
OA symptoms measured by the WOMAC
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.
Sponsors and contacts
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