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临床试验/NCT05432921
NCT05432921进行中(未招募)不适用

Evaluation of Outpatient Cardiac Rehabilitation in Austrian Outpatient Facilities.

Prof. Josef Niebauer M.D., Ph.D., MBA1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2022年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,500
试验地点
1
主要终点
Change from baseline in physical work capacity (PWC) in phase III rehabilitation

研究概览

简要总结

Cardiac rehabilitation (CR) is a key component of the treatment of cardiac diseases. The Austrian outpatient CR model is unique, as it provides patients with an extended professionally supervised, multidisciplinary program of 4-6 weeks of phase II (OUT-II) and 12 months of phase III (OUT-III) CR CR including a "refresher". The aim of this retrospective analysis is to pool data from preferably all Austrian outpatient rehabilitation facilities and to analyze the efficacy of the Austrian cardiac rehabilitation model with a special focus on phase III. Data of patients who completed OUT-III between 1.1.2019 and 01.07.2022 will be analyzed. All patients undergo assessment of anthropometry, resting blood pressure, lipid profile, fasting blood glucose, exercise capacity, quality of life, anxiety and depression at the beginning (T1), in the middle (T2) and end of CR (T3).

详细描述

Cardiac rehabilitation (CR) is a multidisciplinary therapeutic intervention aimed at regaining and maintaining long-term professional and social integration. Specialist societies classify cardiac rehabilitation with the highest recommendation level (Class I). The focal points of therapy in cardiac rehabilitation include health education, optimization of risk factors through psycho-social counseling and structured physical training.

The four-tier Austrian model of cardiac rehabilitation consists of phase I, which takes place in the acute care hospital directly after a cardiac event or intervention/surgery. Phase II ideally follows immediately and lasts 3-4 weeks as an inpatient or alternatively 6 weeks as an outpatient CR. In the subsequent phase III patients ideally transfer knowledge and skills gained during rehabilitation into their daily lives. Supervised outpatient training is carried out once or twice a week for 6 months and takes part in psycho-social and physical health training courses. This is followed by a 3-6 months lasting "home phase" in which patients to follow the agreed-on lifestyle changes on their own, while documenting successes and problems. After this home phase, the Austrian model provides a "refresher" consisting of two guided outpatient training sessions as well as psychological consultation and a medical examination including a stress test. The refresher must be completed within a maximum of four weeks and is a unique feature of the Austrian model, aiming to achieve sustainable lifestyle modification. The patient-financed and life-long phase IV begins no later than 18 months after the start of phase II. Its aim is to achieve an improvement in the prognosis through lifelong, autonomous and self-responsible behavior and long-term prevention.

The aim of this retrospective analysis is to pool data from preferably all Austrian outpatient rehabilitation facilities and to analyze the efficacy of the Austrian cardiac rehabilitation model with a special focus on phase III.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient who meets inclusion criteria for outpatient cardiac rehabilitation in Austria

排除标准

  • Patients are excluded, if they don't meet the inclusion criteria.

结局指标

主要结局

Change from baseline in physical work capacity (PWC) in phase III rehabilitation

时间窗: 12months

PWC is measured during a graded exercise test on a cycle ergometer at begin and end of outpatient cardiac rehabilitation

Change from baseline in physical work capacity (PWC) within the first 6month of Phase III

时间窗: 3-6months

PWC is measured during a graded exercise test on a cycle ergometer at begin and midtime of outpatient cardiac rehabilitation

次要结局

  • Change from baseline in LDL-Cholesterol in Phase III rehabilitation(12months)
  • Change from baseline in Triglycerides in Phase III rehabilitation(12months)
  • Change from baseline in Glucose in Phase III rehabilitation(12months)

研究者

发起方
Prof. Josef Niebauer M.D., Ph.D., MBA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Josef Niebauer M.D., Ph.D., MBA

Head of Institute

Paracelsus Medical University

研究点 (1)

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