Purpose of the study: The effect of exercise during hemodialysis on self-efficacy and fatigue of patients: Single-blind randomized clinical trial.
The sample of the study involves HD patients undergoing hemodialysis referring to Shahid Madani hospital. The sample size is 46 patients with available sampling conducted, will be selected based on inclusion criteria and will be divided into two groups; Will be randomized layout blocks type.
First, fatigue and efficacy of all patients will be measured by demographic questionnaires, Sherer General Self-Efficacy Scale (SGSES) and Fatigue Severity Scale (FSS).
Then, the experimental group for 8 weeks and three days in every week will do the exercise with a stationary bike and control group will receive usual interventions.
Efficacy and fatigue will be measured and compared using a questionnaire after 8 weeks.
After collecting data from all subjects, the results will be analyzed using SPSS 20.
Inclusion criteria: Over 18; at least 6 months of hemodialysis history.
Exclusion criteria: physical limitations in self-care, orthopedic problems preventing exercise, a Plan for Sport since 6 months ago.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016063028715N1
Registration date:2016-09-08, 1395/06/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-08, 1395/06/18
Registrant information
Name
Tahereh Zarei
Name of organization / entity
Tabriz University Of Medical Siencise
Country
Iran (Islamic Republic of)
Phone
+98 41 3479 6770
Email address
zareit@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-08-31, 1395/06/10
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise during hemodialysis on self-efficacy and fatigue in pationts: Single-Blind Randomized Clinical Trial.
Public title
The effect of exercise during hemodialysis on self-efficacy and fatigue.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Over 18; at least 6 months of hemodialysis history; to be literate; Willingness to participate in a sports program by obtaining informed consent.
Exclusion criteria: physical limitations in self-care, orthopedic problems preventing exercise, a Plan for Sport since 6 months ago; having cardiovascular disease, asthma and severe heart failure according to the specialist and patient records preventing exercise.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Tabriz University of Medical Siences
Street address
Tabriz University of Medical Siences, Golgasht street, Azadi street, Tabriz.
City
Tabriz
Postal code
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.TBZMED.REC.1395.484
Health conditions studied
1
Description of health condition studied
Chronic Kidney Diseas
ICD-10 code
N18.5
ICD-10 code description
Chronic Kidney Disease, stage 5
Primary outcomes
1
Description
Self Efficacy
Timepoint
Before Sampling and after the 8-week exercise program
Method of measurement
Sherer General Self-Efficacy Scale questionnaire
2
Description
Fatigue
Timepoint
Before sampling and after the 8-week exercise program
Method of measurement
Fatigue Severity Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention patients group will do eight-week exercise program including a pedal bike during hemodialysis in a dialysis center, under the supervision of a physician and specialist in exercise physiology. Before starting a workout, vital signs (blood pressure, pulse and respiration) of all patients will be controlled. Exercise program includes a bicycle pedal. All of them are according to the recommendations in the context of the exercise of ESRD patients which involves three days a week and each session lasts about 30 to 60 minutes in the first two hours of dialysis.
Category
Other
2
Description
Patients in the control group do not participate in the exercise program and receive regular treatment.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Zarei Tahereh
Street address
Shahid Madani Hospital, Next to Tabriz University, Golbad street, Azadi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Doctor Mohammad Reza Rashidi
Street address
3rd floor, Central Building No. 2, Tabriz University of Medical Sciences, Golgasht Street.
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Siences
Full name of responsible person
Parvan Kobra
Position
Faculty member
Other areas of specialty/work
Street address
South Shariati Street, School of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41334796770
Fax
Email
parvank@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Siences
Full name of responsible person
Parvan Kobra
Position
Faculty member
Other areas of specialty/work
Street address
South Shariati Street, faculity of Nursing and Midwifery
City
Tabriz
Postal code
Phone
+98 41334796770
Fax
Email
parvank@tbzmed.ac.ir parvank@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Siences
Full name of responsible person
Zarei Tahereh
Position
MS Nursing Student
Other areas of specialty/work
Street address
South Shariati Streetو School of Nursing and Midwifery
City
Tabriz
Postal code
Phone
00
Fax
Email
nursezarei@yahoo.comzareit@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)