PARQVE Prior to Total Knee Replacement
研究概览
地位
条件
详细说明
Total knee arthroplasty (TKA) is generally advocated as an effective operation to alleviate symptoms in people suffering from knee osteoarthritis (OAJ). Such statements are often made from a medical and biomechanical perspective (in terms of low complication rates and prosthesis failure) instead of the patient's perspective (pain and functional outcome). Hawker et al. Demonstrated that almost half of the patients submitted to TKA had poor results regarding pain and function; these were mainly elderly patients with additional comorbidities.
Elderly patients, a majority of the population submitted to TKA, have a lower capacity for adaptation to hospitalization and surgical stress. Exercise before cardiac and abdominal elective surgery was shown to reduce the number of complications.
Pre- and postoperative physical therapy may increase the functional recovery of patients undergoing TKA. To date, a number of reviews have been available that demonstrate that preoperative exercise in subjects awaiting TKA has little value in postoperative outcomes. However, most of the included studies investigated the efficacy of preoperative exercise in generally healthy adults, while, in essence, eligible individuals with comorbidities and / or elderly were excluded. Therefore, to understand and appreciate the true potential of preoperative therapeutic exercise, the investigators needs to evaluate studies that included individuals at highest risk for disappointing outcomes after surgery. Two studies are available that investigated the merits of preoperative exercise in patients with increased risk of late functional recovery or increased length of hospital stay. Topp et al. investigated the efficacy of the therapeutic exercise in patients with low preoperative functional level pending TKA. This study demonstrated that, after 3 months, the functional performance level and strength of the preoperative exercise group was greater than the control group. Hansen et al. have demonstrated that, in the context of FAST TRACK, the preoperative therapeutic exercise in individuals with a higher risk of delayed recovery may further decrease hospital stay (one additional day) after TKA.
Even excluding patients with comorbidities Villadsen et al. demonstrated that patients undergoing an exercise program before TKA recovered faster after surgery.
In previous work performed by the authors, patients submitted to an education and physical activity program showed improvement in WOMAC, which can be reproduced in any basic health care unit.
Thus the investigators believe that the sum of an education program associated with preoperative exercises needs to be considered as a tool to help recovery after TKA, as it is an inexpensive, well tolerated and easily implemented intervention in UBS.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
São Paulo、巴西、05403-010
- Instituto de Ortopedia e Traumatologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women diagnosed with OAK with comorbidities (metabolic syndrome, i.e. OAK + at least two overweight / central obesity, diabetes, dyslipidemia, hypertension)
- Age between 60 and 75 years who are waiting Total knee arthroplasty
- Patients not submitted to previous arthroplasty in the lower limbs.
- Patients not submitted to infiltration in the knees up to 6 months before the study.
- Patients with no personal history of cognitive, psychiatric and / or neurological disorders, whose symptoms presented at the time of evaluation are related or significantly interfere with the functions of attention, memory, logical reasoning, comprehension, in order to impair the assimilation of the given guidelines.
- Patients with no personal history of inflammatory arthritis (rheumatoid arthritis, for example)
- Patients able to read, understand and respond to questionnaires and perform functional tests.
Exclusion Criteria:
- Missing in interventions and do not perform the tasks determined by the professionals.
- Patients submitted to infiltration in the knees during the study.
- Patients diagnosed with chronic inflammatory arthritis (rheumatoid arthritis, for example) during the study.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Experimental
Multiprofessional and educational Program prior to Total knee replacement TKA.
(PARQVE TKA).
|
Patients will participate in two days of about knee OA lectures two months apart, will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy followed by 7 sessions with the physical educators team. Following this program, patients will be operated (total knee arthroplasty). Answer Womac, VAS, Lequesne, BMI and body fat percentage - at inclusion, one week prior to surgery, 1 and 6 months postoperatively. Days of hospital stay will be measured by the number of nights the patients stay in the hospital postoperatively and also days in semi-intensive. Minutes and type of physical activity - Answer at inclusion and six months postoperatively. Perform STS30 and TUG at inclusion, one week prior to surgery, 1 and 6 months postoperatively Costs will be evaluated for cost-effectiveness and cost-utility analysis |
|
有源比较器:Control
Patients will be submitted to total knee replacement.
|
Patients will be submitted to total knee replacement, without Multiprofessional and educational Program Answer Womac, VAS, Lequesne, BMI and body fat percentage - at inclusion, one week prior to surgery, 1 and 6 months postoperatively. Days of hospital stay will be measured by the number of nights the patients stay in the hospital postoperatively and also days in semi-intensive. Minutes and type of physical activity - Answer at inclusion and six months postoperatively. Perform the STS30 and TUG at inclusion, one week prior to surgery, 1 and 6 months postoperatively |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change the functional results of patients in the sit to stand 30 seconds
大体时间:6 months
|
To evaluate whether the multiprofessional treatment program and exercises improves the functional results of patients in the sit to stand 30 seconds (STS30) in the 6th.
month of the study (Project PARQVE prior to TKA).
|
6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Improves results of Sit to Stand 30 Seconds Test
大体时间:1 month
|
Perform Sit to Stand 30 Seconds Test - Involves recording the number of stands a person can complete in 30 seconds, more fast better.
|
1 month
|
|
Improves results of Time Up and Go Test
大体时间:1 month and 6 months
|
Perform Time Up and Go Test - The time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down, faster perform better.
|
1 month and 6 months
|
|
Improves results of Womac Questionnaire
大体时间:1 month and 6 months
|
Answer Womac Questionnaire - Ranges: minimum 0 (Better, no pain and limitation) / maximum 96 (Worst pain and limitation)
|
1 month and 6 months
|
|
Improves results of Lequesne Questionnaire
大体时间:1 month and 6 months
|
Answer Lequesne Questionnaire - Ranges: minimum 0 (Better, no limitation) / maximum 24 (Worst limitation)
|
1 month and 6 months
|
|
Improves results of Visual Analogue Scale
大体时间:1 month and 6 months
|
Answer Visual Analogue Scale - Ranges: minimum 0 (Better, no pain) / maximum 100 (Worst pain)
|
1 month and 6 months
|
|
Improves results of EuroQol Scale
大体时间:1 month and 6 months
|
Answer EuroQol Scale - Ranges: minimum 0 (Better) / maximum 2 (Worst)
|
1 month and 6 months
|
|
Increases lean mass percentage
大体时间:1 month and 6 months
|
Calculate lean mass
|
1 month and 6 months
|
|
Decreases fat percentage
大体时间:1 month and 6 months
|
Calculate fat percentage
|
1 month and 6 months
|
|
Increases minutes per week of physical activity
大体时间:6 months
|
Answer questionnaire
|
6 months
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Decreases length of hospital stay
大体时间:6 months
|
Make an economic evaluation of the program regarding cost-effectiveness and cost-utility.
|
6 months
|
合作者和调查者
调查人员
- 首席研究员:Guilherme P Ocampos, MD、University of Sao Paulo General Hospital
出版物和有用的链接
一般刊物
- Wright AA, Cook CE, Baxter GD, Dockerty JD, Abbott JH. A comparison of 3 methodological approaches to defining major clinically important improvement of 4 performance measures in patients with hip osteoarthritis. J Orthop Sports Phys Ther. 2011 May;41(5):319-27. doi: 10.2519/jospt.2011.3515. Epub 2011 Feb 18.
- Hoogeboom TJ, Oosting E, Vriezekolk JE, Veenhof C, Siemonsma PC, de Bie RA, van den Ende CH, van Meeteren NL. Therapeutic validity and effectiveness of preoperative exercise on functional recovery after joint replacement: a systematic review and meta-analysis. PLoS One. 2012;7(5):e38031. doi: 10.1371/journal.pone.0038031. Epub 2012 May 31.
- Hawker GA, Badley EM, Borkhoff CM, Croxford R, Davis AM, Dunn S, Gignac MA, Jaglal SB, Kreder HJ, Sale JE. Which patients are most likely to benefit from total joint arthroplasty? Arthritis Rheum. 2013 May;65(5):1243-52. doi: 10.1002/art.37901.
- Hoogeboom TJ, Dronkers JJ, Hulzebos EH, van Meeteren NL. Merits of exercise therapy before and after major surgery. Curr Opin Anaesthesiol. 2014 Apr;27(2):161-6. doi: 10.1097/ACO.0000000000000062.
- Mak JC, Fransen M, Jennings M, March L, Mittal R, Harris IA; National Health and Medical Research Council (NHMRC) of Australia. Evidence-based review for patients undergoing elective hip and knee replacement. ANZ J Surg. 2014 Jan-Feb;84(1-2):17-24. doi: 10.1111/ans.12109. Epub 2013 Mar 15.
- Topp R, Swank AM, Quesada PM, Nyland J, Malkani A. The effect of prehabilitation exercise on strength and functioning after total knee arthroplasty. PM R. 2009 Aug;1(8):729-35. doi: 10.1016/j.pmrj.2009.06.003.
- Hansen TB, Bredtoft HK, Larsen K. Preoperative physical optimization in fast-track hip and knee arthroplasty. Dan Med J. 2012 Feb;59(2):A4381.
- Villadsen A, Overgaard S, Holsgaard-Larsen A, Christensen R, Roos EM. Postoperative effects of neuromuscular exercise prior to hip or knee arthroplasty: a randomised controlled trial. Ann Rheum Dis. 2014 Jun;73(6):1130-7. doi: 10.1136/annrheumdis-2012-203135. Epub 2013 May 9.
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.