The aim of this study is to evaluate the effects of home walking exercise on self-efficacy and functional ability of hemodialysis patients. The sample of the study includes 60 HD patients undergoing hemodialysis in Fatemeh Zahra and Emam Khomeini hospital in Mazandaran, Iran. This study is a randomized clinical trial in which hemodialysis patients randomly allocated to 2 groups of exercise and control group.Inclusion criteria: age 18 to 65 years, at least six months hemodialysis history, the ability to walk independently, no history of unstable angina and heart attack in the past month, shortness of breath and severe heart failure which prevents the exercise program, physician allow to walk at home . Exclusion criteria included not participating in sports programs as much as four times in total and The patient withdrew the study.
First, functional ability and self-efficacy of all patients will be measured by, Six minute walk test, Exercise Self-Efficacy Scale (ESES) and chronic disease self-efficacy scale (CDSES) and demographic questionnaires. The experimental group for 2 weeks will do the core stability exercise then after two weeks they will do the home walking exercise for 6 weeks (three days in every week and 30 minutes each day). Patient in control group will receive usual care. Self-Efficacy and functional ability will be measured and compared after 2 and 8 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016111824342N4
Registration date:2017-01-02, 1395/10/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-02, 1395/10/13
Registrant information
Name
Vida Shafipour
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7342
Email address
v.shafipour@mazuma.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Research and Technology, Mazandaran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise training on self-efficacy and functional ability of hemodialysis patients
Public title
The effect of exercise training on self-efficacy and functional ability
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 65 years, at least six months hemodialysis history, the ability to walk independently, no history of unstable angina and heart attack in the past month, shortness of breath and severe heart failure which prevents the exercise program, physician allow to walk at home, tend inclusion, no history of hospitalization within the past 6 months, not participate in a regular exercise program in 6 months ago, lack of orthopedic problems in the lower extremities such as hips, knees and ankles that prevents walking.
Exclusion criteria included not participating in sports programs as much as four times in total and The patient withdrew the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
All patients randomly allocated to 2 groups with the aid of computer software by professor of statistics .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Mazandaran University of Medical Sciences
Street address
Moalem Square.
City
sari
Postal code
Approval date
2010-10-25, 1389/08/03
Ethics committee reference number
IR.MAZUMS.AC.IR.95.2428
Health conditions studied
1
Description of health condition studied
hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
hemodialysis
Primary outcomes
1
Description
functional ability
Timepoint
Before the intervention, 2weeks after started the intervention and 2 months after started the intervention
Method of measurement
6MWt (six minute walk test)
2
Description
exercise self efficacy
Timepoint
Before the intervention, 2weeks afterstarted the intervention and 2 months after started the intervention
Method of measurement
exercise self efficacy questionnaire(ESES)
3
Description
Chronic diseases self efficacy
Timepoint
Before the intervention, 2weeks afterstarted the intervention and 2 months after started the intervention
intervention1 (intervention group)
First,before the study, functional ability will be measured by Six minute walk test and self-efficacy of patients measured by Exercise Self-Efficacy Scale (ESES) and chronic disease self-efficacy scale (CDSES) and demographic questionnaires. The experimental group for 2 weeks will do the core stability exercise then after two weeks functional ability and self efficacy in patients will measured again. after that, they will do the home walking exercise for 6 weeks (three days in every week and 30 minutes each day). after six weeks Self-Efficacy and functional ability will be measured again.
Category
Behavior
2
Description
intervention2 (control group)
The control group received routine medical care. before started the study and after 2weeks and after 8 weeks, functional ability will be measured by Six minute walk test and self-efficacy of patients will be measured by Exercise Self-Efficacy Scale (ESES) and chronic disease self-efficacy scale (CDSES) and demographic questionnaires.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemeh Zahra Hospital
Full name of responsible person
Maryam Alizadeh
Street address
Artesh Boulevard,shahrdari square
City
sari
2
Recruitment center
Name of recruitment center
EmamKhomeiny Hospital
Full name of responsible person
habibollah deilamy
Street address
EmamKhomeiny street-Namaz Boulevard
City
fereydoonkenar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of Research and Technology, Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Esmaeili
Street address
Moalem Square
City
sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of Research and Technology, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Marzieh Hatef
Position
Master Critical Care Nursing Student
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street , Amir Mazandarani Boulevard
City
Sari
Postal code
4989726391
Phone
+98 11 3566 8684
Fax
Email
m.hatef90@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Vida SHafipour
Position
Phd.Educational Nursing-faculty member
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street , Amir Mazandarani Boulevard
City
sari
Postal code
Phone
+98 11 3336 7342
Fax
Email
v.shafipour@mazuma.ac.ir; vidashafipour@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Marzieh hatef
Position
Master Critical Care Nursing Student
Other areas of specialty/work
Street address
Nasibeh School of Nursing and Midwifery, Vesal Shirazi Street , Amir Mazandarani Boulevard
City
Sari
Postal code
4989726391
Phone
+98 11 3566 8684
Fax
Email
m.hatef90@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)