Effect of Different Modes of Isotonic Exercises on Clinical Outcomes and Cartilage Biomarkers in Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in function score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index
研究概览
简要总结
This is a randomized controlled trial examining and compare the effects of open and closed kinetic chain exercises on pain, function, and cartilage synthesis and degradation biomarkers after an eight-week rehabilitation program for knee osteoarthritis (OA) patients.
详细描述
Design and Subjects: A prospective, active control, three-parallel-group, assessor-blinded, randomized controlled trial. A sample of 120 subjects will be recruited and randomly assigned to one of three study groups at a 1:1:1 allocation ratio (40 participants per group): a) Standard care only, b) Closed kinetic chain exercises plus standard care, and c) Open kinetic chain plus standard care.
Intervention: participants will receive 24 treatment sessions (3 sessions/week) over 8 weeks. Participants will be allocated to the experimental groups will receive the standard care protocol in addition to either closed or open-chain exercises.
Outcome measures: The primary outcomes are physical function and pain assessed using the Western Ontario and McMaster Universities (WOMAC) scores. Secondary outcomes include the Numeric Pain Rating Scale, quadriceps and hamstring strength, joint range of motion (ROM), joint proprioception error, and serum and urine OA biomarkers including the Serum cartilage oligomeric matrix protein (COMP), Serum propeptide Type-II N-terminal (PIIANP), Serum C- reactive protein (CRP), and Urine type -II Collagen telopeptide (CTX-II).
Data Analysis: Data will be analyzed using the intension-to-treat (ITT) analysis with multiple imputations. The primary analysis of the primary outcomes at a two-month follow-up time point (after completing the intervention protocol for 8 weeks) will be carried out using a mixed-model analysis of variance (ANOVA) test with adjustment for a set of pre-specified baseline factors. Secondary analysis using the ANOVA test for the primary outcomes at a six-month follow-up time point, and secondary outcomes at all follow-up time points will also be carried out.
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
- Single (Outcomes Assessor)
盲法说明
Both the outcome assessors and the study statistician will be blinded to group allocation.
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥40 years of age;
- •having knee pain;
- •having at least three of the following additional symptoms: a-morning stiffness ≤ 30 minutes, b-crepitation, c-bone margin tenderness, d-bony enlargement or e-no palpable warmth;
- •willing to provide informed consent
排除标准
- •Knee joints showing Kellgren and Lawrence (K-L) grades 1 or 4;
- •rheumatoid arthritis;
- •serious pathological conditions (inflammatory arthritis and malignancy); total or partial arthroplasty of the affected knee joint, or on a waiting list for joint replacement surgery;
- •recent surgical procedure of the lower extremities in the previous 6 months;
- •uncontrolled hypertension and unstable cardiovascular problems that could subject the participant to increased risk with exercise and physical exertion;
- •physical incapability to safely perform exercises, walking or stationary cycling, as in debilitating visual defects, neurological problems, exaggerated low back pain, advanced osteoporosis, and inability to walk 10 meters without an assistive device;
- •use of prescribed analgesics, corticosteroid or analgesic injection intervention for knee pain within the previous 30 days;
- •lack of clear comprehension of study procedures or inability to comply with instructions;
- •stated inability to attend or complete the proposed course of intervention and follow-up schedule.
结局指标
主要结局
Change in function score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index
时间窗: Baseline, 2, and 6 months follow-up
A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.
Change in pain score using the Arabic version of the Western Ontario and McMaster Universities (WOMAC) index
时间窗: Baseline, 2, and 6 months follow-up
A 5-point Likert scale comprised of 24 questions across 3 subscales. Standardized answers are assigned a score from 0 (no symptoms) to 4 (extreme symptoms) with higher scores indicating worst pain, stiffness, and function.
次要结局
- Change in knee joint range of motion (ROM)(Baseline, 2, and 6 months follow-up)
- Change in isometric muscle strength(Baseline, 2, and 6 months follow-up)
- Change in knee joint proprioception(Baseline, 2, and 6 months follow-up)
- Change in knee pain using the Arabic version of the Numeric Pain Rating Scale (ANPRS)(Baseline, 2, and 6 months follow-up)
- Change in knee OA biomarkers(Baseline, 2, and 6 months follow-up)
研究者
Ahmed Farrag
Assisstant professor
Prince Sultan Military College of Health Sciences