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

June 16, 2019 updated by: Menachem Nahir, HaEmek Medical Center, Israel

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Ran Vainer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Procedure: 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.
No Intervention: control
Patients who chose not to participate in the rehabilitation program, despite being offered the option.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ACS- Activity Card Sort
Time Frame: 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.
10 min.
International Physical Activity Questionnaire-IPAQ
Time Frame: 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.
5 min.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MoCA - Montreal Cognitive Assessment Tool
Time Frame: 10 min.
Examines various cognitive domains: Attention and concentration, memory, language, and conceptual thinking, calculations, and spatial orientation.
10 min.
TUG - Timed up and go test
Time Frame: 5 min.
Evaluates: Mobility, stability, ability to walk and risk of falling in adults. Participants are required to perform a task: "You need to get up from a chair, walk 3 meters quickly and confidently, step over a symbol marked on the floor, turn around, go back and sit down on the chair."
5 min.
Timed Up and Go dual task - with cognitive task
Time Frame: 5 min.
A dynamic Test, for the evaluation of performance and the risk of falling, during the dual task. The test simulates the conditions of the natural environment in which a person is required to perform multiple tasks Participants are required to perform a task: "You need to get up from a chair, walk 3 meters quickly and confidently, step over a symbol marked on the floor, turn around, go back and sit down on the chair. While performing the task you need to subtract the number 3 from a random number between 20 and 100".
5 min.
Grip Strength test
Time Frame: 5 min.
Testing for an objective and quantitative measure of isometric muscle strength of the hand and forearm muscles. Grip strength that is lower than expected for age has been associated with premature mortality, evolving disability and lengthy rehabilitation after surgery or hospitalization
5 min.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HaEmek Medical Center, Israel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Menachem Nahir, Haemek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0180-16-EMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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