The Efficacy of Progressive Resistance Exercises Versus Aerobic Exercises on Cartilage Morphology and Physical Function in Patients With Degenerative Meniscus Tear: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Short echo T2*
研究概览
简要总结
This randomized controlled trial aims to evaluate the efficacy of progressive resistance exercises (PRE) versus aerobic exercises on cartilage morphology and physical function in patients with degenerative meniscus tears. 45 participants, aged 35-55, will be randomly assigned to one of three groups: PRE, aerobic exercise, or control (standard of care physical and medical therapy). The study will utilize MRI T2 mapping to assess changes in cartilage composition and patient-reported and performance-based measures to evaluate clinical outcomes. This pilot study will also determine the feasibility and issues related to recruitment and retention for a larger trial.
详细描述
Background: Degenerative meniscus tears are common in individuals over 35 and are associated with early stages of knee osteoarthritis (OA) (1,2). Metabolic and microstructural changes within the cartilage occur before surface breakdown, which can now be detected using advanced MRI techniques such as T2 mapping. Exercise therapy, specifically progressive resistance and aerobic exercises, has shown benefits for knee OA patients, but its effects on early cartilage degeneration are poorly understood.
Objective: The primary objective of this study is to determine the efficacy of PRE and aerobic exercises on the metabolic function and microstructure of cartilage in individuals with degenerative meniscus tears but without radiographic evidence of knee OA. Secondary objectives include evaluating the impact of these exercises on clinical outcomes, such as pain, disability, and physical function, and assessing the feasibility of recruitment and retention for a larger trial.
Methods: The study will enroll 54 participants, who will be randomized into three groups: PRE, aerobic exercise, and control. Each group will undergo a 3-month supervised exercise program. MRI scans will be used to measure changes in cartilage composition, while clinical outcomes will be assessed using patient-reported and performance-based measures.
Intervention Groups:
Group 1 (PRE): Participants will perform progressive resistance exercises focusing on strengthening the quadriceps. The exercises will be adjusted based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique.
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 (Investigator, Outcomes Assessor)
盲法说明
In this study, the outcomes assessor and the investigators will be blinded to the group allocation. The outcomes assessor will be unaware of the participants' group assignments to minimize the potential bias in evaluating outcomes. Similarly, the treatment assignment will only be displayed to the principal investigator once it has been determined that the subject meets all eligibility criteria, thus preserving concealed allocation of the randomization assignment from the study investigators and the individuals responsible for subject recruitment and follow-up. To minimize bias throughout the study, individuals responsible for collecting the outcome measures will remain blinded to group assignment for the duration of the study.
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are between 35 and 55 years of age.
- •Have a symptomatic degenerative medial meniscus tear as evidenced by:
- •Presence of medial knee pain.
- •Medial joint line tenderness.
- •Pain and limited motion when attempting to perform a full squat and
- •Increased intra-meniscal signal on at least 2 consecutive MRI slices and
- •Have clearance from their personal physician to participate in an exercise program.
排除标准
- •Radiographic evidence of OA (K-L grade 2 or above).
- •A repairable meniscus injury (longitudinal tear in the outer 1/3 of the meniscus).
- •A meniscus injury that requires meniscectomy (locked knee).
- •Prior or current ligament injury or surgery of the involved knee.
- •Prior or current injury or surgery to contra-lateral knee.
- •Pathological ligamentous laxity upon examination of the knee
- •An inflammatory arthritic condition or
- •Any injury or condition involving the lower extremities that affects their ability to walk.
- •Because participation in this study requires undergoing MRI, subjects will be excluded if they:
- •If female, pregnant at the time of enrollment.
- •Had prior surgery for an aneurysm; any medical illness that may interfere with the patient's general fitness or exercise capability.
- •Had any contraindication with MRI.
- •Had surgery within the past two months.
- •Have a cardiac pacemaker.
研究组 & 干预措施
Progressive Resistance Exercise (PRE)
Participants will perform progressive resistance exercises focusing on strengthening the quadriceps muscles. The exercises will be adjusted based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique.
干预措施: Progressive Resistance Exercise (PRE) (Other)
Aerobic Exercise
Participants will engage in aerobic exercise sessions using a stationary bike, aimed at improving cardiovascular fitness and knee joint mobility.
干预措施: Aerobic Exercise (Other)
Control
Participants will receive standard of care, including general strength and balance exercises as per current clinical guidelines.
干预措施: Control (Other)
结局指标
主要结局
Short echo T2*
时间窗: Baseline, 3-month, 12-month, and 5 years follow-ups.
Short echo time T2\* imaging is used to diagnose early cartilage degeneration. T2\* measures the rate at which the MRI signal decays, particularly focusing on short-T2 signals (less than 10 milliseconds) which decay rapidly (3-6).
Short echo T2*
时间窗: Baseline, 3-month, 24-month, and 5 years follow-ups.
Short echo time T2\* imaging is used to diagnose early cartilage degeneration. T2\* measures the rate at which the MRI signal decays, particularly focusing on short-T2 signals (less than 10 milliseconds) which decay rapidly (3-6).
次要结局
- Maximal voluntary isometric contraction test(Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.)
- Single leg hop test for a distance(Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.)
- The Single Leg Chair Rise (SLCR) test(Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.)
- The Modified Bruce Treadmill Testing Protocol(Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.)
- International Knee Documentation Committee Subjective Knee Form (IKDC)(Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.)
- Single Leg Squat Test(Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.)
- The Timed Stair Climbing Test (SCT)(Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.)
- The Knee injury and Osteoarthritis Outcomes Score (KOOS)(Baseline, immediately post-intervention, 3-month, 6-month, 12-month, and 5 years follow-ups.)
- Single leg hop test for a distance(Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.)
- Single Leg Squat Test(Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.)
- The Timed Stair Climbing Test (SCT)(Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.)
- The Single Leg Chair Rise (SLCR) test(Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.)
- Maximal voluntary isometric contraction test(Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.)
- The Modified Bruce Treadmill Testing Protocol(Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.)
- International Knee Documentation Committee Subjective Knee Form (IKDC)(Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.)
- The Knee injury and Osteoarthritis Outcomes Score (KOOS)(Baseline, 6-week, immediately post-intervention, 6-month, 9-month, and 5 years follow-ups.)