Prospective, Assessment of Vitamin D and Calcium Supplementation, Improvement of Nutritional Status and Preoperative Rehabilitation in Patients Before Knee Arthroplasty.
2020年2月28日 更新者：Bartlomiej Szpyra、Jagiellonian University
Prospective randomized study of 150 patients qualified for knee arthroplasty between 2015 and 2017. Patients were randomized into 3 groups receiving vitamin D and calcium supplementation, increased protein supply and preoperative rehabilitation, respectively.
Following factors were analyzed: changes in vitamin D3, calcium, total protein, albumin and CRP levels during preparation for surgery, nutritional status on the Subjective Global Assessment (SGA) scale, osteoporosis risk assessment according to the Osteoporosis Risk SCORE, level of pain felt on the scale VAS and the number of analgesics used, the result of the Duke Activity Status Index, the result of the following scales: Cardiac Risk Index for Orthopedic Surgery (Lee), Knee injury and Osteoarthritis Outcome Score (KOOS), Fear Avoidance Beliefs Questionnaire (FABQ) about Physical Activity, The Quality of Life Scale (QOLS). Additionally, the occurrence of perioperative complications was analyzed (e.g. venous thrombosis and pulmonary embolism, wound or joint infection, excessive bleeding, loosening of the implant, bone fracture or fracture, pain).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
150
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Malopolska
-
Kraków、Malopolska、波兰、31-559
- Bartlomiej Szpyra
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 85年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- with a disease lasting more than 5 years and without total limitation of physical fitness,
- reporting pain> 5 on the VAS scale (Visual Analogue Scale)
- general fitness according to the ASA (Amercican Society of Anestesiology) scale up to 3
Exclusion Criteria:
- patients with metabolic and systemic disorders with contraindications for calcium substitution, vitamin D3 and protein supply,
- intolerance of physical effort> 2, 5 MET (Metabolic Equivalent of Task)
- limitation of the degree overall efficiency> 3 in the ASA classification
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Intervention group 1
Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
|
Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
|
|
有源比较器：Intervention group 2
Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
|
Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
|
|
安慰剂比较：Control group 0
no protein supplementation , no Vitamin D and calcium supplementation , no exercise
|
no protein supplementation , no Vitamin D and calcium supplementation , no exercise
|
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 |
|---|---|---|
|
Pain control satisfaction assessed on the Visual Analogue Scale (VAS)
大体时间：18 months
|
Visual Analogue Scale (VAS) is a measure determining the intensity of pain by means of a visual analogue scale.
Subject is marking the examined point on a line of 10 cm long, where the value 0 is assigned the total absence of pain, and 10 the strongest pain that can be imagined.
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18 months
|
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Vitamin D concentration in blood, based on laboratory analysis.
大体时间：18 months
|
Concentration of vitamin D in blood is a laboratory parameter, measured in unit of ng/ml.
Levels below 20 ng/ml is a severe vitamin D deficiency condition that requires treatment.
The result in the range 20-30 ng/ml means that the vitamin level is not sufficient.
Values between 30-50 ng/ml are considered normal.
This is one of the basic laboratory parameters for assessing the body's bone mineral metabilism.
|
18 months
|
|
Efficiency of the knee joint assessed on The Knee Injury and Osteoarthritis Outcome Score (KOOS) scale.
大体时间：18 months
|
The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a questionnaire designed to assess short and long-term patient-relevant outcomes following knee injury.
The KOOS is self-administered and assesses five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life.
Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures.
Scores between 0 and 100 represent the percentage of total possible score achieved.
|
18 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Calcium ionized concentration in blood, based on laboratory analysis.
大体时间：18 months
|
Calcium ionized concentration in blood is a laboratory parameter, measured in unit of mmol/l.
The results below 1.16 mmol/l mean that the level is not sufficient, condition called hypocalcemia.
Values between 1.16-1.32
mmol/l are considered normal.
The results above 1.32 mmol/l mean hypercalcemia occurs.
This is one of the basic laboratory parameters for assessing the body's bone mineral metabilism.
|
18 months
|
|
Total protein concentration in blood, based on laboratory analysis.
大体时间：18 months
|
Total protein concentration in blood is a laboratory parameter, measured in unit of g/l.
The results below 60 g/l mean that the level is not sufficient, condition called hypoproteinemia.
Values between 60-80 g/l are considered normal.
The results above 80 g/l mean hyperproteinemia occurs.
This is one of the basic laboratory parameters for assessing the body's nutritional status.
|
18 months
|
|
Albumin concentration in blood, based on laboratory analysis
大体时间：18 months
|
Albumin concentration in blood is a laboratory parameter, measured in unit of mg/ml.
The results below 35 mg/l mean that the level is not sufficient, condition called hypoalbuminemia.
Values between 35-50 mg/ml are considered normal.
The results above 50mg/l mean hyperalbuminemia occurs.
This is one of the basic laboratory parameters for assessing the body's nutritional status.
|
18 months
|
|
C-reactive protein (CRP) concentration in blood, based on laboratory analysis
大体时间：18 months
|
C-reactive protein concentration in blood is a laboratory parameter, measured in unit of mg/l.
The results below 5 mg/l are considered normal.
The results above 5mg/l mean infection, trauma, stress or other aggravating factor.
This is the major laboratory parameter for assessing homeostatic balance.
|
18 months
|
|
Efficacy of protein supplementation assessed on the Subjective Global Assessment (SGA) scale.
大体时间：18 months
|
Subjective global assessment (SGA) is the gold standard for diagnosing malnutrition.
SGA is a simple bedside questionnaire method used to diagnose malnutrition and identify those who would benefit from nutrition care.
The assessment includes taking a history of recent intake, weight change, gastrointestinal symptoms and a clinical evaluation.
Results are on a scale from 1 to 7. Values 1 and 2 means high risk of malnutririon, from 3 do 5 medium risk, and from 6 do 7 mild risk.
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18 months
|
|
Efficacy of vitamin D and calcium supplementation assessed on the Simple Calculated Osteoporosis Risk Estimation (SCORE) scale.
大体时间：18 months
|
Simple Calculated Osteoporosis Risk Estimation (SCORE) scale is the questionnaire tool for diagnosing Osteoporosis risk.
It has been reported to appropriately identify person who should be referred for bone densitometry.
Results are on a scale from 0 to 50 points.
Points from 16 to 50 means high risk of osteoporosis , points from 7 to 15 moderate risk and from 0 do 6 low risk of osteoporosis.
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18 months
|
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Acceptability of physical activity based on Duke Activity Status Index (DASI) scale.
大体时间：18 months
|
The Duke Activity Status Index is a self-administered questionnaire that measures a patient's functional capacity.
It can be used to get a rough estimate of a patient's peak oxygen uptake.
Results are on a scale from 0 to 57,95 points.
The higher the score, the more intense the acceptable physical activity.
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18 months
|
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Incidence of cardiovascular hazard based on Cardiac Risk Index for Orthopedic Surgery (Lee) scale.
大体时间：18 months
|
Cardiac Risk Index for Orthopedic Surgery (Lee) is the questionnaire tool for diagnosing cardiovascular hazard in orthopedics patients.
Results are on a scale from 0 to 6 points.
Points from 3 to 6 means estimated risk of 4%, 2 points is 2,3% of risk, 1 point is 1,7% of risk and 0 points means less than 1 % of cardiovascular event.
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18 months
|
|
Unwillingness of phisical activity due to pain based on Fear Avoidance Beliefs Questionnaire (FABQ) scale.
大体时间：18 months
|
Fear Avoidance Beliefs Questionnaire (FABQ) scale is a questionnaire based on the Fear-Avoidance Model of Exaggerated Pain Perception, a model created in attempts to explain why some patients with acute painful conditions can recover while other patients develop chronic pain from such conditions.
The FABQ focuses specifically on how a patient's fear-avoidance beliefs about physical activity and work.
It consists of 16 questions scaled form 0 do 6, higher score indicates fear avoidance behaviors.
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18 months
|
|
The Quality of Life based on The Quality of Life (QOLS) scale.
大体时间：18 months
|
The Quality of Life (QOLS) scale is the most known scale measures factors like satisfaction, perceptions of control, involvement, commitment, and work-life balance, in terms of one's personal perception.
QOLS has 16 items, scaled form 1 do 7, higher score indicates superior appraisal of each aspect of life.
|
18 months
|
|
Incidence of Treatment-Emergent Adverse Events (AE) as assessed by frequency.
大体时间：18 months
|
Incidence of Adverse Events (AE) was summed up and analyzed in each group. They were divided into 7 groups.
|
18 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年1月1日
初级完成 (实际的)
2017年12月31日
研究完成 (实际的)
2017年12月31日
研究注册日期
首次提交
2020年2月27日
首先提交符合 QC 标准的
2020年2月28日
首次发布 (实际的)
2020年3月2日
研究记录更新
最后更新发布 (实际的)
2020年3月2日
上次提交的符合 QC 标准的更新
2020年2月28日
最后验证
2020年2月1日
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.