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临床试验/NCT03032146
NCT03032146已完成不适用

The Effect of a Cardiac Rehabilitation Program on Active Participation in the Community and Exercise Habits Six Months After a Coronary Event

HaEmek Medical Center, Israel1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
International Physical Activity Questionnaire-IPAQ

研究概览

简要总结

The aim of this study is to examine the contribution of a cardiac rehabilitation program on the active participation in daily life six months after an acute coronary event.

100 patients will be recruited for the study, 3-10 months after a myocardial infarction and hospitalization in the Emek Medical Center in Afula, Israel.

50 patients recruited for the study who had participated in cardiac rehabilitation will be the experimental group. 50 patients who have not participated in rehabilitation- will be the control group. The groups will be matched for diagnosis, sex and age. Sociodemographic data on patients will be taken from the medical records of the cardiology department and the Cardiac Rehabilitation Institute of the Emek Medical Center..

Course of study: Participants will sign an informed consent form and fill out questionnaires that evaluate active participation in the community. In addition, the physical function and muscle strength of the participants will be evaluated with designated tests. The duration of each meeting will be 60 minutes.

HYPOTHESES

  1. Patients who participate in a cardiac rehabilitation program will exhibit higher indices of participation in the community than patients who do not participate.
  2. Patients who participate in a cardiac rehabilitation program will display higher levels of physical activity when compared with patients who do not participate.

详细描述

Cardiac rehabilitation is a multidisciplinary framework which focuses on improving the functioning of heart disease patients to facilitate and optimize the return to a regular routine as early as possible. The rehabilitation program provides the tools for the maintenance of a healthy lifestyle, encouraging participants to take part in recreational activities and includes extending their daily functioning. (IADL- Instrumental Activities of Daily Living). A sedentary lifestyle is a major risk factor for heart disease. Increased levels of physical activity and an active lifestyle have a beneficial effect on most of the risk factors for the heart and blood vessels, including lipid profile, blood pressure and body composition.

In addition to the purely physical component, active participation in managing the household, returning to work and leisure activities in the community, have a positive impact on the mental state and contribute to the quality of life of cardiac patients.

Few studies address the return to a normal social life, most focus on the return to work. Since most cardiac rehabilitation program participants are pensioners, it is important to examine other aspects of their participation in society and everyday life in order to measure the effectiveness of a cardiac rehabilitation program.

The setting up of an initial interview and approval in principle to take part in the study will be arranged with a telephone call to the potential participant and a date will be determined for the meeting..

The interview will be conducted in the subject's home. The interviewer will make sure that the participant understands and agrees to the terms of the research. The participant then will fill in and sign a consent form giving the hospital authorization to use his personal details and medical data (gender, age, religion, place of residence).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • A diagnosis of coronary heart disease in the patient's medical file, age of 18 years or more, hospitalization after an acute coronary event, reading and comprehension in the Hebrew language, fulfillment of all requirements to take part in the cardiac rehabilitation program.

排除标准

  • An orthopedic, neurological, psychological or cognitive background that prevents participation in a rehabilitation program or physical activity. Patient's request not to participate.

研究组 & 干预措施

participation in cardiac rehabilitation

Experimental

Patients with at least a month of cardiac rehabilitation at The Emek Medical Center, Afula. Rehabilitation includes a multidisciplinary program based on physical exercise.

干预措施: Cardiac Rehabilitation (Procedure)

control

No Intervention

Patients who chose not to participate in the rehabilitation program, despite being offered the option.

结局指标

主要结局

International Physical Activity Questionnaire-IPAQ

时间窗: 5 min.

A self-reporting questionnaire measuring physical activity in 27 sections. The questionnaire examines the duration (in minutes) and frequency (in days) of physical activity during the previous 7 days. Activity is measured in the following areas: work, mobility, home maintenance, sports recreation, and while sitting.

ACS- Activity Card Sort

时间窗: 10 min.

A questionnaire describing participation in social, instrumental and recreational activities. A questionnaire consisting of 89 sections describing implementation activities sonotosimor activity and participation. 20 clauses describe instrumental activity. 35 clauses describe recreational activity that require minimal physical effort and 17 that require a higher level of effort. 17 additional clauses describe leisure activities.

次要结局

  • MoCA - Montreal Cognitive Assessment Tool(10 min.)
  • TUG - Timed up and go test(5 min.)
  • Timed Up and Go dual task - with cognitive task(5 min.)
  • Grip Strength test(5 min.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Menachem Nahir

Cardiologist, MD.

HaEmek Medical Center, Israel

研究点 (1)

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