Modified Sternal Precautions Versus Conventional Sternal Precautions in Physical Function After Sternotomy
2022年5月31日 更新者:Riphah International University
Effectiveness of Modified Sternal Precautions Versus Conventional Sternal Precautions in Improving Physical Function After Sternotomy
This research study Effectiveness of modified sternal precautions versus conventional sternal precautions in improving physical function after sternotomy .After recruitment of the subjects, the intervention group will receive modified sternal precaution while the control group will receive conventional sternal precautions and they will be assess for their physical activity, kinesiophobia, quality of life and post sternotomy pain.
研究概览
详细说明
This study will address the scarcity of research and the variations in recommendations regarding sternal precautions and restrictions of upper limb movement in cardiac patients and will help to evaluate the effect of modified sternal precautions on patients' pain and functional activity.
As physical therapists are the ones who have maximum exposure to practice and teaching of sternal precautions, therefore this study will help to formulate the guidelines regarding the use of upper limb during cardiac rehabilitation exercises and making standards for sternal precautions and its management following cardiac surgery.
研究类型
介入性
注册 (实际的)
40
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
-
-
KPK
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Peshawar、KPK、巴基斯坦、25000
- Rehman Medical Institute
-
-
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
40年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Open heart surgery patients (CABG and Valve surgeries)
Exclusion Criteria:
- Unstable vitals
- Patient needing maximum assistance
- Decline consent
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: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:Modified sternal precautions
Interventional group (Modified sternal precautions)
|
Use pain and discomfort to guide the safe use of the arms Avoid pushing or pulling with one arm Use both arms close to the body during lifting Use of arms is possible, but keep them close to the body Avoid stretching one or both arms backwards at the same time Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging 'posture) when coughing. When transferring, roll onto the side, ease the legs over the edge of the bed and carefully use the arms to sit up from a lying position |
|
有源比较器:Conventional sternal precautions
Control group (Conventional sternal precautions)
|
Avoid pushing or pulling through the arms Avoid one-arm (unilateral) activity Limit the elevation of the arms to 90 degrees Avoid lifting objects heavier than 2 kg Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging' posture) when coughing Limit the use of the arms when transferring from sitting to standing and getting out of bed Avoid placing the arms behind the back
|
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 |
|---|---|---|
|
Short physical performance battery
大体时间:4 Week
|
SPBB is a commonly used tool in clinical setting for measuring the physical performance of patients.
It is known for its feasibility and shorter time to conduct.
It has been used in different studies for reporting outcome measure post cardiac surgery.
This outcome measure is also selected due to its high validity and reliability.
The reliability of the test is 0.87.
It is divided into three subtests: balance, a short walk at normal pace and lastly standing up from a chair five times repeatedly.
These subsets exemplify core tasks being important for independent living.
|
4 Week
|
|
Functional difficulties questionnaire
大体时间:4 week
|
Functional difficulties questionnaire is a functional outcome measures that specially focuses on the thoracic region and upper limb movements in people following cardiac surgery.
The validity of the questionnaire is 0.971 while its reliability is 0.918.
The questionnaire is divided into 13 questions which consists of functional tasks, causing difficulty following cardiac surgery.
Participants are required to mark on an unmarked 10cm VAS the level of difficulty they experienced when completing each of the included tasks, based on the previous time they experience.
|
4 week
|
|
Tampa scale of Kinesiophobia (TSK-II)
大体时间:4 week
|
It is a broadly used tool to measure pain related fear beliefs regarding movement and re-injury.
The validly of the questionnaire range between 0.74 to 0.87 and its reliability is 0.747.
It is a self-reported questionnaire.
It includes 11 questions scale on likert scale ranging from 1 to 4 where 1 means strongly disagree while 4 means strongly agree.
The total score ranges between 11 to 44.
Higher score indicate high level of kinesiopobhia.
A reduction of points equal or more than 3 points accounting for about 10% is considered as relevant change.
|
4 week
|
|
Mcgill pain questionnaire - short form version 2 (SF-MPQ-2)
大体时间:4 Week
|
It is one of the most widely used questionnaire for the measurement of pain.
Its benefit is that it provides valuable information on the sensory, affective and evaluative dimensions of pain experience by an individual.
It has a capability of discriminating among different types of pain problems.
It has become one of the most commonly used tests for the measurement of pain following cardiac surgery via sternotomy.
The reliability of the questionnaire ranges from 0.75 to 0.83.
|
4 Week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Health survey (SF-36)
大体时间:4 week
|
This questionnaire provides overall measure of quality of recovery of patient according to the patient's perspective.
It is a reliable and valid tool used mainly in clinical practices to measure health related quality of life following cardiac surgery.
The reliability of scale is 0.65 to 0.96.
This tool consists of eight domains comprising of physical functioning, role physical functioning, role emotional functioning, mental health, vitality, social functioning, bodily pain and general health.
Responses are recorded on a five-point Likert scale and then transformed onto a 100-point scale.
Score higher than 50 shows better health state and less pain experienced
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4 week
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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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.
- Price KJ, Gordon BA, Bird SR, Benson AC. A review of guidelines for cardiac rehabilitation exercise programmes: Is there an international consensus? Eur J Prev Cardiol. 2016 Nov;23(16):1715-1733. doi: 10.1177/2047487316657669. Epub 2016 Jun 27.
- Epstein AJ, Polsky D, Yang F, Yang L, Groeneveld PW. Coronary revascularization trends in the United States, 2001-2008. JAMA. 2011 May 4;305(17):1769-76. doi: 10.1001/jama.2011.551.
- Deb S, Wijeysundera HC, Ko DT, Tsubota H, Hill S, Fremes SE. Coronary artery bypass graft surgery vs percutaneous interventions in coronary revascularization: a systematic review. JAMA. 2013 Nov 20;310(19):2086-95. doi: 10.1001/jama.2013.281718.
- Hodge T. Fast Facts for the Cardiac Surgery Nurse: Caring for Cardiac Surgery Patients in a Nutshell: Springer Publishing Company; 2015.
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)
2020年9月19日
初级完成 (实际的)
2021年3月28日
研究完成 (实际的)
2021年3月31日
研究注册日期
首次提交
2021年2月2日
首先提交符合 QC 标准的
2021年2月4日
首次发布 (实际的)
2021年2月5日
研究记录更新
最后更新发布 (实际的)
2022年6月1日
上次提交的符合 QC 标准的更新
2022年5月31日
最后验证
2022年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- REC00707 Huma Balqias
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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