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

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ClinicalTrials.gov Identifier: NCT03032146
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Menachem Nahir, HaEmek Medical Center, Israel

Tracking Information
First Submitted Date  ICMJE January 24, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date June 18, 2019
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • 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.
  • 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."
  • 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".
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of a Cardiac Rehabilitation Program on Active Participation in the Community and Exercise Habits
Official Title  ICMJE The Effect of a Cardiac Rehabilitation Program on Active Participation in the Community and Exercise Habits Six Months After a Coronary Event
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cardiac Event
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Cardiac Rehabilitation
  • No Intervention: control
    Patients who chose not to participate in the rehabilitation program, despite being offered the option.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 1, 2018
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032146
Other Study ID Numbers  ICMJE 0180-16-EMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Menachem Nahir, HaEmek Medical Center, Israel
Study Sponsor  ICMJE HaEmek Medical Center, Israel
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Menachem Nahir haemek medical center
PRS Account HaEmek Medical Center, Israel
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP