Efficacy of Pre-operative Quadriceps Strength Training on Knee-extension Strength Before and Shortly Following Total Knee Arthroplasty: A Randomized Dose-response Trial (The QUADX-1 Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass
研究概览
简要总结
The trial investigates the efficacy of knee-extension exercise prior to total knee replacement. The participants are randomly allocated to one of three exercise dosages. There is no control group.
详细描述
Patients with end-stage knee osteoarthritis (OA) have decreased knee-extension strength and suffer from knee pain. Strengthening of the knee-extensor muscle is a key element in conservative treatment for patients with knee OA. However, the most effective exercise dosage for knee-extension strength exercise is unknown.
In this trial the investigators investigate the efficacy of three different dosages of knee-extension strength exercise. Patients eligible for total knee replacement are offered home-based pre-operative knee-extension exercise and are randomly allocated to one of three exercise dosage groups. There is no control group. The knee-extension exercise is performed with an elastic exercise band mounted with sensor (BandCizer) which registers when the patients exercise, how much they exercise and how they exercise.
The intervention time is 12 weeks and the primary time point of interest is after exercise/just before surgery. Secondary time points of interest are shortly after surgery and three months after surgery.
The patients are given detailed exercise instruction at trial entry and hereafter they exercise unsupervised at home for 12 weeks. At week 4 and 8 they receive follow-up instruction.
Both the patients who choose not to have TKA and those who do after the exercise period will be followed with annual outcome assessments as part of a follow-up cohort.
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)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is a possible candidate for a primary TKA due to knee osteoarthritis
- •Patient is eligible for home-based quadriceps exercise
- •Patient has an age ≥ 50 years
- •Patient is a possible candidate for primary unilateral TKA, based on all the below terms:
- •Knee pain >3 (Numeric Rating Scale) in the last week
- •Kellgren-Lawrence classification grade ≥2
- •Oxford Knee Score <30
- •Patient is resident in one of the three municipalities (København, Hvidovre or Brøndby) involved in the trial
- •Patient is able to speak and understand Danish
排除标准
- •Exercise is contra-indicated for the patient
- •Patient has a neurological disorder
- •Patient has a diagnosed systemic disease (ASA score ≥ 3)
- •Patients with terminal illness
- •Patient has severe bone deformity demanding use of nonstandard implants
- •Weekly alcohol consumption above national recommendations (>7 units women, >14 units men)
结局指标
主要结局
Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass
时间窗: Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery
The measurement will be assessed using a computerized strength chair (Good Strength Chair, Metitur Oy, Jyvaskyla, Finland).
次要结局
- 6 min walk test for distance (6MWT)(Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery)
- Oxford Knee Score (OKS)(Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery)
- Stair climb test (SCT)(Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery)
- Knee pain(Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery)
- Isometric knee-extension strength at 60 degrees knee flexion measured as Nm/kg body mass(Change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery)
- Knee Osteoarthritis Outcome Score (KOOS)(Change from 1) baseline to 2) after 12 weeks of exercise/just before surgery, and change from 1) baseline to 3) at hospital discharge (3-8 days after surgery), and change from 1) baseline to 4) three months after surgery)
- Exercise adherence(Assessment at 2) after 12 weeks of exercise/just before surgery)
- Surgical status(Assessment at 2) after 12 weeks of exercise/just before surgery)
研究者
Rasmus Skov Husted
PhD, MSc., PT.
Hvidovre University Hospital