The Effect of a Cardiac Rehabilitation Program on Active Participation in the Community and Exercise Habits

NCT ID: NCT03032146

Last Updated: 2019-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-11-01

Brief Summary

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.

Detailed Description

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).

Conditions

Cardiac Event

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

participation in cardiac rehabilitation

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

Group Type: EXPERIMENTAL

Cardiac Rehabilitation

Intervention Type: PROCEDURE

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.

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cardiac Rehabilitation

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Menachem Nahir

Cardiologist, MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Menachem Nahir

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

Ran Vainer

Afula, , Israel

Countries

Israel

Other Identifiers

0180-16-EMC

Identifier Type: -

Identifier Source: org_study_id