A two-phase double-blinded randomised controlled trial on structured home-based exercise program (HEP) and concentric versus eccentric-based stair training program (CSTP versus ESTP) for pain and function in knee osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- pain (NPRS), pressure pain threshold (Algometer), and functional ability (WOMAC)
研究概览
简要总结
This two-phase, double-blindedrandomized controlled trial will evaluate the effectiveness of a structured home-basedexercise program (HEP) and concentric versus eccentric-based stair trainingprogram (CSTP versus ESTP) for individuals with knee osteoarthritis (OA). Thiswill be conducted for 16 weeks with a 24-week follow-up, the study aims toassess pain, functional improvement, and long-term benefits. Primary outcomesinclude pain severity, pressure pain threshold, and functional ability, whilesecondary measures focus on muscle strength, range of motion, aerobic capacity,and quality of life. Findings will provide evidence for accessible andsustainable rehabilitation strategies for knee OA, contributing to improvedpatient outcomes and non-pharmacological self-management options.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 45.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •For Phase I.
- •Individuals will be included in this trial if (1) ages 45 – 70 for both men and women; (2) the presence of knee OA for at least six months following American College of Rheumatology criteria; (3) able to walk without the use of any aids and able to flex the knee beyond 90 degrees; (4) anterior-posterior bilateral standing radiograph presents Kellgren and Lawrence Grade II/III knee OA; (5) having smartphone for watching video tutorial. For Phase II.
- •Individuals will be included if (1) complete Phase I home-based exercise program (HBEP); (2) pain subsides during walking and staring.
排除标准
- •For Phase I.
- •Individuals will be excluded if (1) knee surgery has been performed in the previous twelve months; (2) lumbar radiculopathy, vascular claudication, severe anterior-sided knee pain resulting from patella-femoral syndrome or chondromalacia, as well as further neurological, muscular, or joint conditions that could impair the function of the lower limbs; (3) visible malformation of the knee, either varus or valgus; (4) Received hyaluronic acid or corticosteroid injections within three months of study enrollment; (5) pregnancy (6) BMI over
- •For Phase II.
- •Individuals will be excluded if – (1) present signs of knee OA following American College of Rheumatology criteria;16 (2) the presence of unusual cardiac response during the six-minute walk test and staring.
结局指标
主要结局
pain (NPRS), pressure pain threshold (Algometer), and functional ability (WOMAC)
时间窗: At baseline, week-8, week-16 and week-24 follow-up
次要结局
- muscle strength (sphygmomanometer), range of motion(goniometer), aerobic capacity (6MWT), and quality of life(SF-36(At baseline, week-8, week-16 and week-24 follow-up)