Efficacy of High Intensity Preoperative Training on Postoperative Outcomes in Greek Patients Undergoing Total Knee Arthroplasty: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 主要终点
- Change of Quadriceps strength
研究概览
简要总结
Purpose: The purpose of this study was to investigate the efficacy of a 6-week supervised high-intensity preoperative training program on muscle strength, functional performance and patient-reported outcomes in patients undergoing total knee arthroplasty (TKA).
Methods: Eighty-eight patients scheduled for unilateral TKA for severe osteoarthritis (OA) were randomly allocated to intervention group (N=44) completed a 6-week preoperative training program, 5 days per week prior to surgery and to control group (N=44) who lived as usual. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Physical Functioning Scale of the Short Form-36 questionnaire (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS), quadriceps strength, 20 meters walk test and 30 seconds chair stand test were assessed at 6 weeks before surgery (T0), after 6 weeks of preoperative training / preoperatively (T1), 4 weeks (T2) and finally 12 weeks (T3) after TKA.
详细描述
The purpose of this study was to investigate the efficacy of 6 weeks of preoperative and 4-week postoperative progressive resistance training (PRT) compared to 4 weeks of postoperative PRT only on functional performance, muscle strength, and patient-reported outcomes in patients undergoing TKA. We hypothesized that 6 weeks of preoperative PRT would be safe and feasible and would improve functional performance, knee extensor and flexor muscle strength, and patient-reported outcomes preoperatively and at 4 and 12 weeks postoperatively, when compared to controls.
Materials and methods
All patients over 60 years old who were diagnosed with advanced idiopathic knee OA (according to the radiological criteria of the American College of Rheumatology Guidelines) and scheduled for unilateral total knee arthroplasty in Orthopedic Clinic of University Hospital of Alexandroupolis, Greece from March 2014 until January 2016 were considered candidates for this study and were informed to participate. Exclusion criteria were medical conditions that exercise was contraindicated (i.e cardiopulmonary comorbidities that precluded modest exercise), diseases that affected their functional performance (suffering from neuromuscular or neurodegenerative conditions), mental diseases, previous hip or knee joint replacement surgery and if they had severe pain in the controlateral limp that would not allow them to follow any pre- or postoperative interventions.
Eligible participants signed an informed consent document approved by The Research Ethics Committee of the Faculty of Health Sciences, National and Kapodistrian University of Athens,(16955 : 03/12/2018) prior to participation in the study. This study took a clinical trial number (registration number 1819019724/23-01-2019) from National and Kapodistrian University of Athens, Greece.
Of the total 234 patients screened, 88 patients were finally included to our study and 136 were excluded. O those, 85 declined to participate and 51 did not meet the inclusion criteria. Patients (N=98) who accepted to participate and fulfilled inclusion criteria were randomly allocated to either the intervention or control group by chart number while their TKA was being scheduled in the orthopedic outpatient department (OPD). The researcher was blinded to the randomization in order to prevent the knowledge of the allocated interventions.
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 (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 60 years
- •Patients were diagnosed with advanced idiopathic knee OA (according to the radiological criteria of the American College of Rheumatology Guidelines)
- •Patients who were scheduled for unilateral total knee arthroplasty in Orthopedic Clinic of University Hospital of Alexandroupolis
排除标准
- •Medical conditions that exercise was contraindicated (i.e cardiopulmonary comorbidities that precluded modest exercise 2) Diseases that affected their functional performance (suffering from neuromuscular or neurodegenerative conditions) 3) Mental diseases 4) Previous hip or knee joint replacement surgery 5) Severe pain on the controlateral limp that would not allow them to follow any pre- or postoperative interventions
研究组 & 干预措施
Intervention Group
Patients who were randomly allocated to intervention group (N=44) completed a 6-week preoperative training program, 5 days per week prior to surgery
干预措施: Preoperative training program (Other)
Control Group
Patients who were randomly allocated to control group (N=44), they continued to live as usual, prior to surgery
结局指标
主要结局
Change of Quadriceps strength
时间窗: Baseline testing occurred 6 weeks before the participant's scheduled TKA. The participants again completed the questionnaires and physical testing at the end of the 6-week intervention, as well as at 4 and 12 weeks after their total knee arthroplasty
All patients performed 3 maximal isometric contractions of the knee extensors at a knee joint angle of 700 (00 = full knee extension) and of the knee flexors at a knee joint angle of 200 with 60 seconds rest in between (Knapik et al., 1983). For further analysis we selected the attempt with the highest peak torque (Nm). The patients performed 6 maximal concentric contractions in full possible range of motion (ROM); the attempt with the highest peak torque was selected for further analysis. Peak torque values were normalized to body weight and reported as Nm/kg
Knee pain
时间窗: Baseline testing occurred 6 weeks before the participant's scheduled TKA. The participants again completed the questionnaires and physical testing at the end of the 6-week intervention, as well as at 4 and 12 weeks after their total knee arthroplasty
the Western Ontario and MacMaster Universities Osteoarthritis Index (WOMAC) score was applied in the Greek-language version. All patients completed the questionnaire 6 weeks before the surgical procedure, 2-3 days before TKA and 4 and12 weeks postoperatively. The WOMAC is a disease-specific, self-administered questionnaire developed to study patients with hip or knee OA and requires about 10-12 minutes to complete. It has a multidimensional scale made up of 24 items grouped into three dimensions: pain (five items), stiffness (two items), and physical function (17 items). The test questions are scored on a scale of 0-4 and the scores for each subscale are summed up, with a possible score range of 0-20 for pain, 0-8 for stiffness, and 0-68 for physical function.
Daily living activities
时间窗: Baseline testing occurred 6 weeks before the participant's scheduled TKA. The participants again completed the questionnaires and physical testing at the end of the 6-week intervention, as well as at 4 and 12 weeks after their total knee arthroplasty
The SF-36 is a valid and reliable instrument for assessing the general health and function of undergoing TKA patients and is a core component of suggested outcome measures for this procedure. The scores of each subscale are normalized to a scale ranging from 0 to 100, with a higher score reflecting a better health status. We used the Greek version of SF-36 Health Survey and we evaluate physical functioning. Knee injury and Osteoarthritis Outcome Score (KOOS) is a useful scale in evaluating symptoms and functional status related to knee injury and knee OA. This tool has five subscales, namely pain, symptoms, daily living, sports and recreational activities, and quality of life related to the knee. KOOS has high test-retest reliability.
Knee joint function
时间窗: Baseline testing occurred 6 weeks before the participant's scheduled TKA. The participants again completed the questionnaires and physical testing at the end of the 6-week intervention, as well as at 4 and 12 weeks after their total knee arthroplasty
The 20-meter walk test is frequently used in clinical trials and cohort studies involving individuals with OA, as well as in physical therapy. We measured the 20-meter walk course with a measure wheel and we measured how many seconds each patients neede to complete this distance. The investigator stopped timing as soon as the participant's first heel completely crossed the strip of tape. Studies reported that the 20-meter walk test has a high test-re-test reliability among patients with end-stage OA awaiting knee replacements Additionally, we used the 30-second chair stand test that involves recording the number of stands a person can complete in 30 seconds. The participant is seated back straight in the middle of a chair without arms (seat height 45 cm).The participant is instructed to fully sit between each stand and encouraged to complete as many full stands as possible within 30 seconds.
次要结局
未报告次要终点
研究者
Dimitrios Vasileiadis
Principal Investigator Mr Dimitrios Vasileiadis
National and Kapodistrian University of Athens