The effect of exercise during dialysis on health promotion behaviors in patients undergoing hemodialysis
Design
A controlled clinical trial with a parallel group design of 60 patients
Settings and conduct
study setting: hemodialysis centers belonging to Isfahan University of Medical Sciences including dialysis department of AL-zahra hospital and dialysis center of Nour and aliasghar. How to do the study: Patients will divided into two groups of intervention and control. The intervention group will exercise for 30 minutes. Health promotion behaviors questionnaire will completed by them. The control group will receive simple exercise and will complete the questionnaire of Health promotion behaviors. This work will done for 8 weeks.
Participants/Inclusion and exclusion criteria
Incusion criteria: age between 18 and 65 years, Having full consciousness and being able to listen and speak to answer to questions, Having history of hemodialysis more than 3 month, Having 3 dialysis sessions per week.
Exclusion criteria: having physical and mental disabilities, having known ischemic heart disease, heart attacks and angina during the last three months, suffering from acute pulmonary disease and needing for oxygen during dialysis, having a history of stroke or ischemic attacks over the last 3 months, suffering from muscle disorders that prevent Intended exercise
Intervention groups
Intervention group: the intervention group will participate in a exercise program.In this program, they will exercise in 2 courses (30 minute) and between these courses, the patient will rest for 30 minutes. This exercise is done for 8 weeks , three times a week.
Control group: The patients will receive simple exercise (10 minutes), 3 times a week for 8 weeks.
Main outcome variables
The health promotion behaviors
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150116020675N3
Registration date:2019-01-18, 1397/10/28
Registration timing:retrospective
Last update:2019-01-18, 1397/10/28
Update count:0
Registration date
2019-01-18, 1397/10/28
Registrant information
Name
Alireza Dashti
Name of organization / entity
Alzahra Hospital
Country
Iran (Islamic Republic of)
Phone
+98 31 3620 1322
Email address
alireza_dashti@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-02, 1397/04/11
Expected recruitment end date
2018-09-02, 1397/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of exercise during hemodialysis on health promoting behaviors of hemodialysis patients
Public title
The effect of exercise during hemodialysis on health promoting behaviors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
being age between 18 and 65 year
Having full consciousness and being able to listen and speak to answer to questions
Having history of hemodialysis more than 3 months
Having 3 dialysis sessions per week
Exclusion criteria:
having physical and mental disabilities
having known ischemic heart disease, heart attacks and angina during the last three months
suffering from acute pulmonary disease and needing for oxygen during dialysis
having a history of stroke or ischemic attacks over the last 3 months
suffering from skeletal muscle disorders that prevent Intended exercise
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
•Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746734461
Approval date
2018-07-01, 1397/04/10
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.014
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
health promoting behaviors
Timepoint
At the beginning of the study, 8 weeks after the beginning of the intervention
Method of measurement
health promoting behaviors questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the intervention group will participate in a exercise program.In this program, they will exercise in 2 courses (30 minute) and between these courses, the patient will rest for 3o minute. This exercise is done by fixed bike. The intensity of the exercise will depend on the machine rotation round and is selected by patient.This exercise is done for 8 weeks , three times a week.
Category
Other
2
Description
Control group: The patients will receive a simple exercise (10 minute), 3 times a week for 8 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Alireza Dashti Dehkordi
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1322
Email
alireza_dashti@nm.mui.ac.ir
Web page address
http://alzahra.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nahid Shahgholian
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7565
Email
shahgholian@nm.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Dashti Dehkordi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1322
Email
alireza_dashti@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nahid Shahgholian
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7565
Email
shahgholian@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Dashti Dehkordi
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1322
Email
alireza_dashti@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available