First Affilated Hospital of Jinzhou Medical University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Knee KOOS4
研究概览
简要总结
The aim is to determine the outcomes of calorie-restricted diet and exercise intervention; libitum diet and waiting list control; early arthroscopic partial meniscectomy(APM) or delayed APM effect on MetS patients with Degenerate menisucus lesions.
详细描述
The investigators recruited 180 patients with Metabolic Syndrome and knee symptoms with degenerate meniscus lesions by MRI from orthopaedics department from June 2017 to March 2020 at First Affiliated Hospital of Jinzhou Medical University. Participants were diagnosed with MetS and degenerate meniscus tear with a mild or no osteoarthritis KL<2 verified by X ray. Participants were randomly dividied into calorie-restricted diet and exercise intervention group; libitum diet and waiting list control group; early APM (syndrome within 3-6 months) group or a delayed APM(syndrome more than 6 months) group as a computer sequenced number. The primary outcome was the change in metabolic syndrome components and knee function score of WOMAC, KOOS,WOMET,IKDC were determined by two fixed orthopadic surgeons who were blinded to the intervention.
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 (Care Provider, Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be age between 35 and 70 years old;
- •Clinical diagnosis of metabolic syndrome;
- •Clinical diagnosis of 3 grade degneration meniscus leisons;
排除标准
- •Must be able to have no acute knee injury such as car crash or acute sports injury;
- •Must be able to have no knee surgeries history;
- •Must be able to have no rheumatoid arthritis or serious knee osteoarthritis with deformity;
- •Must be able to have no contraindications to MRI;
- •Must be able to have no severe cardiopulmonary disease;
- •Must be able to have no musculoskeletal or neuromuscular impairments ;
- •Must be able to have good visual, hearing, or cognitive;
结局指标
主要结局
Knee KOOS4
时间窗: up to 12 months
the Knee injury and Osteoarthritis Outcome Score (KOOS) holds five subscales: (1) Pain (9 items); (2) other Symptoms (7 items); (3) Activities of Daily Living (ADL, 17 items); (4) Sport and Recreation function (Sport/Rec, 5 items); and (5) knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems) life (KOOs 4 ) were assessed.One of the most frequently-used knee-specific PROMs is the Knee injury and Osteoarthritis Outcome Score (KOOS) which was developed for adults who have knee OA or knee injuries.KOOS holds five subscales: (1) Pain (9 items); (2) other Symptoms (7 items); (3) Activities of Daily Living (ADL, 17 items); (4) Sport and Recreation function (Sport/Rec, 5 items); and (5) knee-related Quality of Life (QoL, 4 items). Each subscale is scored separately from zero (extreme knee problems) to 100 (no knee problems)
weight
时间窗: up to 12 months
weight in kilograms
height
时间窗: up to 12 months
height in meters
triglyceride
时间窗: up to 12 months
triglyceride in mmol/L
LDL-C
时间窗: up to 12 months
low-density lipoprotein cholesterol in mmol/L
β-2 microglobulin
时间窗: up to 12 months
β-2 microglobulin in mg/L
the scale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: up to 12 months
the WOMAC score is a disease-specific self-report multidimensional questionnare assesing pain, siffness, and physical functional disability.WOMAC scores range from 0 to 100, with higher scores indicating worse physical function.
BMI
时间窗: up to 12 months
BMI, calculated as weight in kilograms divided by height in meters squaredBMI in kg/m\^2
cardio vascular disease history
时间窗: up to 12 months
cardio vascular disease history
Kellgren-Lawrence grade
时间窗: up to 12 months
A Kellgren-Lawrence grade of 0 indicates no osteoarthritis, a grade of 1 with questionable osteophyte indicates possible osteoarthritis; a grade of 2 with definite osteophyte and no joint-space narrowing indicates mild osteoarthritis, a grade of 3 with ≤50% joint-space narrowing or a grade of 4 with\>50% joint-space narrowing indicates severe osteoarthritis were excluded.
HDL-C
时间窗: up to 12 months
high-density lipoprotein cholesterol in mmol/L
Lysholm knee score
时间窗: up to 12 months
The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.
The International Knee Documentation Committee Subjective Knee Evaluation Form (IKDC).
时间窗: up to 12 months
The IKDC is a questionnaire that has high reliability and validity for patients with a meniscal tear. The questionnaire contains 18 items scored in 1 of 3 ways: 11-point Likert scale, 5-point Likert scale, or dichotomous yes or no. After the participant completes the questionnaire, the scores are summed, and the total score is transformed to a value on a scale of 0 to 100, with 100 representing the highest knee function.
The WOMET score
时间窗: up to 12 months
The WOMET is a meniscus-specific health-related quality-of-life instrument, validated especially for patients with a degenerative meniscal tear.The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items ad-dressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possi- ble score, and 0 is the worst possible score.
waist circumstance
时间窗: up to 12 months
waist circumstance in centimeter
diastolic blood pressure
时间窗: up to 12 months
diastolic blood pressure in mm Hg
fast blood glucose
时间窗: up to 12 months
fast blood glucose in mmol/L
total Cholesterol
时间窗: up to 12 months
total Cholesterol in mmol/L
diabetes history
时间窗: up to 12 months
diabetes history
hypertension history
时间窗: up to 12 months
hypertension history
systolic blood pressure
时间窗: up to 12 months
systolic blood pressure in mm Hg
次要结局
未报告次要终点
研究者
Hongyu Wang
chief residents
The First People's Hospital of Jingzhou