to determine the effect of selected exercise during dialysis on some hematology indicators and dialysis quality in hemodialysis patients.
Design
controlled clinical trial with a parallel group design of 60 Subjects, Randomised
Settings and conduct
In this quasi-experimental study, referring to Hazrat Abolfazl Dialysis Center in Isfahan, 60 subjects are selected according to the inclusion criteria and are divided into control and intervention groups. Blood samples are taken from patients 48 hours before the start and after the implementation of the training protocol. Some indicators of hematology and quality of blood dialysis are measured. The intervention group will perform a training program during dialysis for 12 weeks and 3 sessions per week. The training program consists of three parts: warm-up, main part and cooling. The warm-up and cooling part include 5 minutes of simple stretching movements and the main part of the exercise includes both isotonic and isometric movements. The control group does not do any exercise program.
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least three months under dialysis treatment, Complete consent of patient to participate in this study.
Exclusion criteria: No history of stroke in the last three months.
Intervention groups
Intervention group: Selected exercises that were dividing into three parts: warm-up, main part and cooling. The warm-up and cooling part consisted of 5 minutes of simple stretching movements, and the main part of the exercise, consisting both isotonic and isometric movements.
Control group: without any intervention.
Main outcome variables
hemoglobin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170510033909N11
Registration date:2021-05-13, 1400/02/23
Registration timing:retrospective
Last update:2021-05-13, 1400/02/23
Update count:0
Registration date
2021-05-13, 1400/02/23
Registrant information
Name
فرزانه تقیان
Name of organization / entity
دانشگاه آزاد اسلامی.واحد اصفهان
Country
Iran (Islamic Republic of)
Phone
+98 913 308 0241
Email address
f.taghian@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-14, 1400/01/25
Expected recruitment end date
2021-04-30, 1400/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of selected exercise during dialysis on some hematology indicators and dialysis quality in hemodialysis patients.
Public title
Exercise and dialysis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least three months on dialysis treatment
Complete patient consent to participate in this study
Exclusion criteria:
No history of stroke in the last three months
Age
From 45 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
Randomization method: Simple randomization;
Randomization Tool: Filip the coin
Randomization Unit: Individual;
This method is used to create random sequences in two-group experiments.
This method is used to create a random sequence in two-group experiments in such a way that one of the study groups is considered a lion and the other group is considered a line, and based on the sample size, the coin is tossed to assign the two groups randomly.
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 on Research Islamic Azad University - Isfahan Branch (Khorasgan)
Street address
University Blvd, Arghavanie, East Gay Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2020-08-19, 1399/05/29
Ethics committee reference number
IR.IAU.KHUISF.REC.1399.146
Health conditions studied
1
Description of health condition studied
hemodialysis patients
ICD-10 code
Z49.31
ICD-10 code description
Encounter for adequacy testing for hemodialysis
Primary outcomes
1
Description
Hematological indicators
Timepoint
At the beginning and end of 12 weeks of study
Method of measurement
It is measured by using the venous blood sample of the subjects and the hematology cell counter analyzer of BC model Mindray company made in Iran.
Secondary outcomes
1
Description
The quality of dialysis
Timepoint
At the beginning and end of the study after 12 weeks
Method of measurement
Will be checked out by two laboratory indicators KT / V and URR. In the KT / V formula, the variable K means urea clearance (dialysis purification rate), T means dialysis time, and V indicates the volume of urea distribution, which is approximately equal to the total body water. The URR was calculated by the formula BUN1-BUN2 / BUN1, which is BUN1 urea before dialysis and BUN2 urea after dialysis.
Intervention groups
1
Description
Intervention group: Selected exercises that were dividing into three parts: warm-up, main part and cooling. The warm-up and cooling part consisted of 5 minutes of simple stretching movements, and the main part of the exercise, consisting both isotonic and isometric movements.
Category
Rehabilitation
2
Description
Control group: without intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Abolfazl Charity Clinic
Full name of responsible person
Mohammad Ali Tabibi
Street address
In front of Social Security Insurance, Imam Khomeini StJomhuri Eslami Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۵۸۵۳۹۳۳
Phone
+98 31 3334 5551
Email
M.tabibi@ut.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
Full name of responsible person
Majid Toghyani
Street address
Khorasgan University, Arghavanie St, Isfaha
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2352
Email
F_taghian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
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
Farzaneh taghian
Full name of responsible person
Islamic Azad University
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183895183
Phone
+98 31335002352
Email
F_taghian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183895153
Phone
+98 81 8389 5183
Email
F_taghian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Khorasgan branch
Full name of responsible person
Farzaneh taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University , Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2352
Fax
Email
F_taghian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD