Clinical trial NCT03032146: The Effect of a Cardiac Rehabilitation Program on Active Participation in the Community and Exercise Habits
Official title: The Effect of a Cardiac Rehabilitation Program on Active Participation in the Community and Exercise Habits Six Months After a Coronary Event
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Event
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with at least a month of cardiac rehabilitation at The Emek Medical Center, Afula. Rehabilitation includes a multidisciplinary program based on physical exercise.
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: ACS- Activity Card Sort
timeFrame: 10 min.
measure: International Physical Activity Questionnaire-IPAQ
timeFrame: 5 min.
Secondary outcomes:
measure: MoCA - Montreal Cognitive Assessment Tool
timeFrame: 10 min.
measure: TUG - Timed up and go test
timeFrame: 5 min.
measure: Timed Up and Go dual task - with cognitive task
timeFrame: 5 min.
measure: Grip Strength test
timeFrame: 5 min.
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Ran Vainer
Study officials:
affiliation: haemek medical center
name: Menachem Nahir
role: PRINCIPAL_INVESTIGATOR
References: