Protocol summary

Summary
The objective of this randomized controlled trial to investigate the impact walking program as a form of rehabilitation is very cheap and accessible to the class of heart failure in patients with heart failure have been designed.The study included all patients with heart failure who are aged above 60 years, with muscular and skeletal problems were, Ejection fraction equal to or greater than 40%, drive failure for 6 months, and for the treatment of the the heart of the city of Arak Amir Kabir hospital CCU or post hospitalization and treatment should be the doctor ordered drug will be discharged. Researchers from all eligible patients, after obtaining written informed consent request that the original questionnaire containing some questions about demographic data and disease characteristics of the patient through the examination and interview, fellow nurses and cardiologists completed, and the fertility complete. Group walking program, including 12 weeks in the company. In this study, exercise, walking at home every day for 5 days a week and once done.(HHRmax) improved (5 minutes each week to add to this increased activity when the activity increased to a maximum of 5% of the rate increase up to a week before). Seniors groups in the first two sessions of exercise program, supervised by researchers with the training, the implementation of sports programs and others with planning meetings for them, alone or with the help of family members will do. Common commands control the hospital received its agenda and will act on them. But at the time of the study, nurses collaborator at the end of every month with the patient and control groups will meet and examine and evaluate the offers. Both groups will be asked if they have any heart problems were due to ask the doctor or nurse collaborator. Finally, after the end of the quarter, the outcome of the case, including the classification of heart function, shortness of breath and test status of both groups will be 6 minutes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201105306634N1
Registration date: 2015-07-19, 1394/04/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-19, 1394/04/28
Registrant information
Name
Soleiman Zand
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3524
Email address
slmnzand@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Sciences Vice chancellor for research,ARAk University of Medical
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2011-12-22, 1390/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of walking on the classification of cardiac function in elderly patients with heart failure
Public title
The effect on elderly patients with heart failure
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Patients with heart failure who are older than 60 years; Patients who are interested in participating in the study; Have the ability to read;It is time, place and people are aware; Patients with muscular and skeletal problems are not physical situation so that the doctor can confirm the physical movements; Ejection fraction equal to or greater than 40% with a diagnosis of heart failure Class I, II and III - drive failure for at least 6 months. Has prevented the development of clinical symptoms. Exclusion criteria : Patients who have Neurologic deficits (stroke, Parkinson's disease and paralysis); Patients with arrhythmias (irregular heart polecat) are uncontrolled; Patients who have severe chest pain are ongoing; Those who are speech or hearing problems; Those who do not have the proper consciousness or mental retardation at all levels with it; Hypertension and diabetes have uncontrolled; History of anxiety disorders are diagnosed; Continuous or three sessions 5 sessions of exercise programs is not done; patients with renal insufficiency (serum creatinin levels over 2.5 mg per deciliter) are;Patientss with obstructive pulmonary disease, ischemia-induced ventricular tachycardia sports; patients with alcoholism;Patients during the study for any reason their failure intensity is increased so that the exercise of his fellow physician is not possible.
Age
From 60 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the Arak University of Medical Sciences
Street address
Ethics Committee, Sciences Vice chancellor for research, Arak University of Medical Sciences,Arak
City
Arak
Postal code
38481-7-6941
Approval date
2011-04-21, 1390/02/01
Ethics committee reference number
7440

Health conditions studied

1

Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Dlassified heart failure
Timepoint
Before the end of intervention intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Dyspnea and a 6-minute test
Timepoint
Before the intervention and (12 weeks) end of intervention
Method of measurement
With activities in 6 minutes and pedometer

Intervention groups

1

Description
Group intervention: After approval of physical condition and the ability to walk by specialist cardiovascular programs, including 12 weeks in a walking program that will Krd.b, exercise program in this study, walk in the house for 5 days a week and will be done once a day. Training in two weeks of a moderate level for 10 minutes with a maximum of 20% of the patient's heart rate will be 10 next week as progressive will increase to more than 60 minutes, and 60 percent of maximum heart rate reserve (HHRmax) will respectively. Seniors groups in the first two sessions of exercise program, supervised by researchers with the training, the implementation of sports programs and others with planning meetings for them, alone or with the help of family members will do. Researcher at the end of each week walking program, patient assessment and plan for the next week to specify and recommend possible they will be trained.
Category
Rehabilitation

2

Description
Group Control: no intervention was not for them. In fact, the control group of normal order the hospital to get his agenda and will act on them. However, during the nurse's initial assessment of the patient collaborator who was not involved in the patient met the end of each month.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Zand Soleiman, MSc,Instructor
Street address
Amir Kabir Hospital, nurse square, Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sciences Vice chancellor for research,Arak University of Medical
Full name of responsible person
Dr:Rafiei Mohamad
Street address
Arak University of Medical,Sciences Vice chancellor for research, University of Medical Sciences, Basij Square,Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sciences Vice chancellor for research,Arak University of Medical
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
Arak University of Medical Sciences
Full name of responsible person
Zand Soleiman
Position
MSc
Other areas of specialty/work
Street address
Department of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3524
Fax
+98 86 3417 3524
Email
slmnzand@arakmu.ac.ir
Web page address
www.arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zand Soleiman
Position
MSc
Other areas of specialty/work
Street address
Department of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3524
Fax
+98 93572572031
Email
slmnzand@arakmu.ac.ir
Web page address
www.arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zand Soleiman
Position
MSc
Other areas of specialty/work
Street address
Department of Nursing, Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Postal code
38481-7-6941
Phone
+98 86 3417 3524
Fax
+98 86 3417 3524
Email
slmnzand@araku.ac.ir
Web page address
www.arakmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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