心脏康复后运动维持的有效性和经济性 (ECOPCR)
男性和女性心脏康复后的生态优化运动维持:一项经济学有效性的随机对照试验
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ontario
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Ottawa、Ontario、加拿大、K1Y4W7
- University of Ottawa Heart Institute
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Toronto、Ontario、加拿大、M5G2C4
- York University and University Health Network
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 患者目前正在参加持续时间≥ 8 周的现场 CR 计划(以确保结果不会因接触基于家庭或基于电话的病例管理计划而混淆)
- 患者已从 CR 毕业(以确保该研究评估干预措施以帮助维持和改善运动行为的维持
- 患者有 CAD 诊断记录(以确保患者群体的同质性)
- 患者年满 18 岁或以上
- 患者能够并愿意提供知情同意
- 能够以每小时 2 英里的速度独立行走
排除标准:
- 患者患有纽约心脏协会 III 级或 IV 级心力衰竭(因为这可能会影响达到推荐运动水平的能力并确保患者群体的同质性)
- 患者在研究期间怀孕、哺乳或计划怀孕(因为这可能会影响达到推荐运动水平的能力)
- 患者无法阅读和理解英语或法语
- 计划在未来 12 个月内离开该省或地区
- 参与者的家庭成员已经参与研究
- 根据合格调查员的意见,参与者无法参加无人监督的锻炼。
学习计划
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 |
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实验性的:运动促进者干预
干预采用小组咨询电话会议 (5)、个人电话联系 (3) 和社区 Heart Wise Exercise 计划演示。
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为期 50 周的干预包括 5 次小组咨询电话会议、3 次个人电话和 Heart Wise Exercise 计划演示。
在电话会议和个人电话中,主持人讨论了锻炼的重要性。
参与者回顾他们的活动日记,找出迄今为止经历过的锻炼维护障碍,并集体讨论解决方案。
此外,主持人还在渥太华和多伦多的 Heart Wise Exercise 计划地点为感兴趣的参与者进行社区计划演示。
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无干预:日常护理
渥太华大学心脏研究所 Minto 预防与康复中心和大学健康网络心血管康复与预防中心为心脏康复毕业生提供的常规护理。
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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 |
|---|---|---|
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9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity
大体时间:Baseline to 52 weeks
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Physical activity will be measured directly by having participants wear the Actigraph GT3X accelerometer (Actigraph, Pensacola, Florida) over the right hip for a 9-day recording period, excluding periods when they are sleeping, swimming, or bathing.
The activity monitor provides measurements including activity counts, energy expenditure, and step counts, in addition to activity intensity levels.
Participants will be considered to be maintaining exercise at guideline recommended levels if they undertake ≥ 30 minutes of moderate and/or vigorous intensity physical activity on ≥ five days.
The results report the average minutes of exercise recorded across the full 9 days wearing the accelerometer.
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Baseline to 52 weeks
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9-day Accelerometer-measured Physical Activity of Moderate and Vigorous Intensity (>/= 10min Sessions)
大体时间:Baseline to 52 weeks
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Physical activity will be measured directly by having participants wear the Actigraph GT3X accelerometer (Actigraph, Pensacola, Florida) over the right hip for a 9-day recording period, excluding periods when they are sleeping, swimming, or bathing. The activity monitor provides measurements including activity counts, energy expenditure, and step counts, in addition to activity intensity levels. Participants will be considered to be maintaining exercise at guideline recommended levels if they undertake ≥ 30 minutes of moderate and/or vigorous intensity physical activity on ≥ five days. Outcome measure 2 reports the average number of minutes recorded over the full 9 days of wearing the accelerometer, but only when the exercise events last for at least 10 minutes. This differs from Primary Outcome 1 because Primary Outcome 1 is an average of all bouts of exercise regardless of sustained time. |
Baseline to 52 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Symptom Limited Graded Exercise Test With Electrocardiographic Monitoring Using a Ramp Protocol on a Treadmill
大体时间:Baseline and 52 weeks
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A random sub-sample of participants will complete a symptom limited graded exercise test with electrocardiographic monitoring using a ramp protocol on a treadmill at baseline and at 52 weeks.
Exercise tolerance will also be assessed using the Duke Activity Status Index (DASI), a self-administered questionnaire that measures a patient's functional capacity and is used as an estimate of an individual's peak oxygen uptake
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Baseline and 52 weeks
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Quality of Life Measured by the the EuroQoL 5D Visual Analogue Scale
大体时间:Baseline to 52 weeks
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The EQ-5D is the current gold standard measure of generic quality of life, has been used in numerous studies and has been validated in many languages.
The EQ-5D consists of 2 pages - the EQ-5D descriptive system and the EQ visual analogue scale.
The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
The Visual analogue scale ranges from 0-100 with 0 rated as the worst health, and 100 being the best health.
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Baseline to 52 weeks
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Cardiovascular Risk Factors Measured by Waist Circumference
大体时间:52 weeks
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Waist circumference is measured using a non-stretchable standard tape measure.
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52 weeks
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Cardiovascular Risk Factors Measured by Systolic Blood Pressure.
大体时间:52 weeks
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Systolic blood pressure is measured in a seated position after a five-minute rest period using an automated, non-invasive blood pressure monitor (BPTru) that automatically performs six measurements.
The results represent the average measurements of the six measurements taken.
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52 weeks
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Cardiovascular Risk Factors Measured by Body Mass Index
大体时间:52 weeks
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Height and weight is measured for the determination of body mass index (BMI).
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52 weeks
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合作者和调查者
调查人员
- 学习椅:Andrew Pipe, MD、Ottawa Heart Institute Research Corporation
- 首席研究员:Robert Reid, MBA, PhD、Ottawa Heart Institute Research Corporation
- 首席研究员:Sherry Grace, PhD、Peter Munk Cardiac Centre
- 学习椅:Caroline Chessex, MD, MSc、Peter Munk Cardiac Centre
- 学习椅:Murray Krahn, MD, MSc、University of Toronto, Toronto Health Economics and Technology Assessment Collaborative
- 学习椅:Doug Manuel, MD、Institute for Clinical Evaluative Sciences
- 学习椅:Kori Kingsbury, MSN, MPA、Cardiac Care Network of Ontario
- 学习椅:Jennifer Harris, BSc, PT、Ottawa Heart Institute Research Corporation
- 学习椅:Kerri-Anne Mullen, MSc、Institute for Clinical Evaluative Sciences
- 学习椅:Amy Mark, PhD、Ottawa Heart Institute Research Corporation
- 学习椅:Chris Blanchard, PhD、Dalhousie University
出版物和有用的链接
一般刊物
- Godin G, Shephard RJ. A simple method to assess exercise behavior in the community. Can J Appl Sport Sci. 1985 Sep;10(3):141-6.
- Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
- Blanchard CM, Courneya KS, Rodgers WM, Fraser SN, Murray TC, Daub B, Black B. Is the theory of planned behavior a useful framework for understanding exercise adherence during phase II cardiac rehabilitation? J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):29-39. doi: 10.1097/00008483-200301000-00007.
- Izawa KP, Watanabe S, Omiya K, Hirano Y, Oka K, Osada N, Iijima S. Effect of the self-monitoring approach on exercise maintenance during cardiac rehabilitation: a randomized, controlled trial. Am J Phys Med Rehabil. 2005 May;84(5):313-21. doi: 10.1097/01.phm.0000156901.95289.09.
- Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005 Mar;43(3):203-20. doi: 10.1097/00005650-200503000-00003.
- Grace SL, Chessex C, Arthur H, Chan S, Cyr C, Dafoe W, Juneau M, Oh P, Suskin N. Systematizing Inpatient Referral to Cardiac Rehabilitation 2010: Canadian association of cardiac rehabilitation and Canadian cardiovascular society joint position paper. J Cardiopulm Rehabil Prev. 2011 May-Jun;31(3):E1-8. doi: 10.1097/HCR.0b013e318219721f.
- Blanchard CM, Reid RD, Morrin LI, McDonnell L, McGannon K, Rhodes RE, Spence JC, Edwards N. Demographic and clinical determinants of moderate to vigorous physical activity during home-based cardiac rehabilitation: the home-based determinants of exercise (HOME) study. J Cardiopulm Rehabil Prev. 2010 Jul-Aug;30(4):240-5. doi: 10.1097/HCR.0b013e3181d0c4ae.
- Reid RD, Dafoe WA, Morrin L, Mayhew A, Papadakis S, Beaton L, Oldridge NB, Coyle D, Wells GA. Impact of program duration and contact frequency on efficacy and cost of cardiac rehabilitation: results of a randomized trial. Am Heart J. 2005 May;149(5):862-8. doi: 10.1016/j.ahj.2004.09.029.
- Bock BC, Carmona-Barros RE, Esler JL, Tilkemeier PL. Program participation and physical activity maintenance after cardiac rehabilitation. Behav Modif. 2003 Jan;27(1):37-53. doi: 10.1177/0145445502238692.
- Izawa KP, Yamada S, Oka K, Watanabe S, Omiya K, Iijima S, Hirano Y, Kobayashi T, Kasahara Y, Samejima H, Osada N. Long-term exercise maintenance, physical activity, and health-related quality of life after cardiac rehabilitation. Am J Phys Med Rehabil. 2004 Dec;83(12):884-92. doi: 10.1097/01.phm.0000143404.59050.11.
- Sallis JF, Kerr J, Carlson JA, Norman GJ, Saelens BE, Durant N, Ainsworth BE. Evaluating a brief self-report measure of neighborhood environments for physical activity research and surveillance: Physical Activity Neighborhood Environment Scale (PANES). J Phys Act Health. 2010 Jul;7(4):533-40. doi: 10.1123/jpah.7.4.533.
- Hodges JM. Reflections: Occupational therapy. Am J Occup Ther. 1976 Aug;30(7):409-10. No abstract available.
- Johnson NA, Lim LL, Bowe SJ. Multicenter randomized controlled trial of a home walking intervention after outpatient cardiac rehabilitation on health-related quality of life in women. Eur J Cardiovasc Prev Rehabil. 2009 Oct;16(5):633-7. doi: 10.1097/HJR.0b013e32832e8eba.
- Reid RD, Morrin LI, Pipe AL, Dafoe WA, Higginson LA, Wielgosz AT, LeHaye SA, McDonald PW, Plotnikoff RC, Courneya KS, Oldridge NB, Beaton LJ, Papadakis S, Slovinec D'Angelo ME, Tulloch HE, Blanchard CM. Determinants of physical activity after hospitalization for coronary artery disease: the Tracking Exercise After Cardiac Hospitalization (TEACH) Study. Eur J Cardiovasc Prev Rehabil. 2006 Aug;13(4):529-37. doi: 10.1097/01.hjr.0000201513.13343.97.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计的)
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
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