This study is a one-group before-after clinical trial will be done to determined the effect of home-based cardiac rehabilitation on fatigue in patients with coronary heart disease.Samples consisted of 50 patients are according to inclusion criteria among patients with coronary heart disease who had referred to the Khorramabad cardiac rehabilitation center will be selected using purposive sampling method. Inclusion criteria included age 70-35 years, stable status of patients to participate in a rehabilitation program, passing 4-6 weeks after discharge, no patient with uncontrolled heart failure, arrhythmias, and unstable angina, non-treated patients with fatigue and sedative agents such as amantadine and the absence of local and systemic reactions in a patient after surgery. Exclusion criteria is non-compliance with recommended sports training and physical disorders and the incidence. Intervention, 4 one-hour sessions over 4 consecutive days face to face training and individual performance.
Data will be collected by demographic characteristics questionnaire,patient self-report form at home and Piper Fatigue Scale (PFS). Fatigue before and 8 weeks after the intervention will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014081618520N1
Registration date:2015-04-26, 1394/02/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-26, 1394/02/06
Registrant information
Name
Saeedeh Piri
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3342 2872
Email address
s_piri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Assistant, School of Nursing and Midwifery martyr Beheshtiresearcher
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-10-22, 1393/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of home-based cardiac rehabilitation on fatigue of patients with Coronary Heart Disease
Public title
Effects of cardiac rehabilitation in the management of fatigue in patients with Coronary Heart Disease
Purpose
Supportive
Inclusion/Exclusion criteria
(Inclusion criteria: Patients aged 35-70 years;
The patient's vital signs (pulse and respiration) are stable for the rehabilitation program;
6-4 weeks after the last patient is discharged; The patient does not have disease limited mobility;
Patients with uncontrolled heart failure, arrhythmia's and angina are not flaky;absence of Mental disorders and related drugs; Patients not treated with drugs that reduce fatigue and sedatives such as amantadine and .... ; The patient has the ability to understand speech in Farsi; The patient is literate; The patient's ability to conduct training sessions of rehabilitation .
Patients have access to a phone; Local and systemic complications after surgery is not present and Exclusion criteria: Failure to follow the recommended training and exercise; cancellation and unwillingness to continue the study; the incidence of mental disorders such as hypertension, hyperglycemia, etc.)
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Shahid Beheshti University of Medical Sciences
Street address
next to the Ayatollah Taleghani Hospital, Shahid Arabi Street, Yemen Street, Shahid Chamran Highway, Tehran
City
Tehran
Postal code
Approval date
2014-12-08, 1393/09/17
Ethics committee reference number
1393-1-86-13393
Health conditions studied
1
Description of health condition studied
CORONARY HEART DISEASE
ICD-10 code
I20-I25
ICD-10 code description
Chronic Ischaemic Heart Disease
Primary outcomes
1
Description
Fatigue
Timepoint
Before and 8 weeks after intervention
Method of measurement
Piper Fatigue Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The study included 4 one hour education sessions of face to face in 4 consecutive days with content of home-based cardiac rehabilitation and followed for 8 weeks after discharging at patient’s home. First session includes learning about diseases, (side effects/ complications) and treatment, and cardiac rehabilitation simply. The second session includes education and prevention of risk factors, including smoking (smoking cessation training set), high blood lipids, hypertension, weight gain and stress. The third session consisted of diet and drug regimen in these patients. The fourth session included instruction on simple physical activity with an emphasis on hiking, sports are allowed in this group of patients and how to control pulse during exercise.
At the end of the fourth session review and discuss the three sessions before and training manual of run training sessions are available to patients and Then the patient is asked for planned exercise three times per week for 8 weeks.
According to above and the need to measure learning in different time intervals, immediately after training the evaluation of patients' rehabilitation center will be performed. Also, after the completion of the rehabilitation program at the end of the fourth week once home visit by the researcher will be made to control the rehabilitation program, trainings presented, solve problems and answers to possible questions.
Then the patient will be asked to mark the adhere to teaching in the home care form that will be give to patients.Note that this form will also be available to researchers and During the 8-week intervention, the researcher will contact with patients once a week to emphasize on the concepts taught, ensure of doing the exercises and in the event of a problem, go back to their homes.Also the phone number of researcher will give to patients to contact in case of any problem or question. At the end of 8 weeks of intervention with visit the patients in their homes , they will be asked to fill questionnaire fatigue again
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiac Rehabilitation Centre ( Heart Healthy Clinic)
Full name of responsible person
Mehrdad Namdari Doctor
Street address
Khorramdabad, Heart Healthy Clinic
City
Khorramdabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masomeh simbar doctor
Street address
School of Nursing and Midwifery,to the Hospital of Shahid Rajai, intersection Niayesh, Valiasr street, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeedeh Piri
Position
Master degree
Other areas of specialty/work
Street address
School of Nursing and Midwifery,to the Hospital of Shahid Rajai, intersection Niayesh, Valiasr street, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
s_piri@sbmu.ac.ir ; saeedepiri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery Shahid Beheshti University of Medical Sciences
Full name of responsible person
saeedeh piri
Position
Master degree
Other areas of specialty/work
Street address
School of Nursing and Midwifery,to the Hospital of Shahid Rajai, intersection Niayesh, Valiasr street, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
s_piri@sbmu.ac.ir ; saeedepiri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty Nursing and Midwifery Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeedeh Piri
Position
Master degree
Other areas of specialty/work
Street address
School of Nursing and Midwifery,to the Hospital of Shahid Rajai, intersection Niayesh, Valiasr street, Tehran
City
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
s_piri@sbmu.ac.ir ; saeedepiri@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)