The effect of exercise during dialysis on the blood levels of Parathyroid hormone, Calcium, Phosphorus, Albumin of patients undergoing hemodialysis
Design
A controlled clinical trial with a parallel group design of 60 patients
Settings and conduct
Study setting: hemodialysis ward of Alzahra Hospital belonging to Isfahan University of Medical Sciences. How to do the study: Patients will divided into two groups of intervention and control. The intervention group will exercise for 30 minutes.Blood samples are given and sent to the laboratory. The control group will receive simple exercise. This work will done for 8 weeks.
Participants/Inclusion and exclusion criteria
Incusion criteria: age between 18 and 65 years old; having full consciousness and being able to listen and speak to answer to questions; history of hemodialysis more than 3 month; having 3 dialysis sessions per week. Exclusion criteria: physical and mental disability; known ischemic heart disease, heart attacks and angina during the last three months; suffering from acute pulmonary disease and needing for oxygen during hemodialysis; history of stroke or ischemic attacks over the last 3 months; suffering from muscle disorders that prevent Intended exercise; history of parathyroidectomy.
Intervention groups
Intervention group: this 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.
Main outcome variables
The levels of Parathyroid hormone; Calcium; Phosphorus; Albumin of blood
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150116020675N4
Registration date:2020-09-01, 1399/06/11
Registration timing:prospective
Last update:2020-09-01, 1399/06/11
Update count:0
Registration date
2020-09-01, 1399/06/11
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
2020-09-22, 1399/07/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect exercise during hemodialysis on blood level of Parathyroid hormone, Calcium, Phosphate and Albumin patients undergoing hemodialysis
Public title
Effect exercise during hemodialysis on blood level of Parathyroid hormone, Calcium, Phosphate and Albumin patients undergoing hemodialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 and 65 years old
Having full consciousness and being able to listen and speak to answer to questions
History of hemodialysis at least 3 months
Not having cardiac ischemia, MI and Cardiac angina over last three months
Not having severe pulmonary disease
Not having history of CVA or ischemic attack over last three months
Not having any skeletal muscular disease that prevents patients from doing exercise
The patients are treated with hemodialysis three times a week (4 hours)
Not having history of parathyroidectomy surgery
Not having physical and mental disability
Exclusion criteria:
Not having tendency to continue participating in the study in any stage of the study
Suffering from cardiovascular, pulmonary diseases and any disorder that prevents the patient from doing exercise during the study.
Not doing exercise for two consecutive sessions or four non-consecutive sessions
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)
Randomized
Randomization description
The patients participating in the study are divided into groups (intervention and control) by simple random allocation method and using a package containing even and odd numbers.
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 School of Medicine - Isfahan University of Medical Sciences
Street address
Hezarjarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746734461
Approval date
2020-06-07, 1399/03/18
Ethics committee reference number
IR.MUI.MED.REC.1399.212
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
The level of parathyroid hormone in blood
Timepoint
At the beginning of the study and 8 weeks after the beginning of the intervention
Method of measurement
Blood Test
Secondary outcomes
1
Description
The levels of Calcium of blood
Timepoint
At the beginning of the study and 8 weeks after the beginning of the intervention
Method of measurement
Blood test
2
Description
The level of phosphorus of blood
Timepoint
At the beginning of the study and 8 weeks after the beginning of the intervention
Method of measurement
Blood test
3
Description
The level of Albumin of blood
Timepoint
At the beginning of the study and 8 weeks after the beginning of the intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: the 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 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: this group will participate in a exercise program include calisthenics exercises which lasts for 10 minute, 8 weeks and three times in the week.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Alireza Dashti dehkordi
Street address
Soffeh Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2268
Email
alireza_dashti@nm.mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo javanmard
Street address
Hezargarib Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3792 3060
Email
sh_haghjoo@med.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 Ave.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2268
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
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Hezargarib Ave.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3822 2268
Email
shahgholian@nm.mui.ac.ir
Web page address
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 Ave..
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 2268
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