Aim: To determine the effect of increasing blood flow rate on physical fatigue dimensions in hemodialysis patients.
Inclusion criteria of study included a being under hemodialysis for at least 6 months, three sessions of dialysis for four hours weekly, having arteriovenous fistula or graft. The exclusion criteria of study included lack of desire to continue the intervention, intolerance to more round number of device and patients who find hemodynamic disorder during the intervention. The study population consisted of patients hospitalized in 17 Shahrivar hospital and Shafa dialysis center. Among all patients, 80 patients were selected using convince sampling method. Two sessions before intervention, researcher referred to department and recorded the pomp round of device for each patient separately and then calculated the mean of two sessions. For experimental group subjects, blood flow rate of hemodialysis device is increases in the first two weeks by 25 rounds compared to mean number of device rounds in two sessions before the start of intervention and during the second two weeks by 50 rounds compared to mentioned mean. In the control group, the mean number of rounds of device is set on same mean round of two sessions before intervention. Dimensions of fatigue are measured using a standard questionnaire MFI before intervention, two weeks (sixth session) and four weeks (twelfth session) after the intervention in the experimental and control groups (before and after the dialysis session) will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042433617N1
Registration date:2017-05-24, 1396/03/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-24, 1396/03/03
Registrant information
Name
Hossein Kakhki Jaghargh
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1510
Email address
kakhkih931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences and Health Services.
Expected recruitment start date
2017-05-13, 1396/02/23
Expected recruitment end date
2017-11-14, 1396/08/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Increasing blood flow rate on Dimensions of fatigue in hemodialysis patients
Public title
The effect of Increasing blood flow rate on Dimensions of fatigue in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: desire to participate in the study؛ being under hemodialysis for at least 6 months؛ having a history in hemodialysis department of the study environment؛ three sessions of dialysis for four hours weekly؛ having arteriovenous fistula or graft؛ having a degree of fatigue based of fatigue measurement standard questionnaires MFI؛ absence of history of hemodialysis complications (hemodynamic, etc.) in the past month؛ absebce of intellectual disabilities or cognitive disorders؛ lack of chronic debilitating such as heart and respiratory class 4 diseases confirmed by department physician؛ mean pump round less than 300 (cc per minute) during two sessions before sampling؛
lack of mental diseases such as major depression and no history of psychiatric hospitalization؛ absence of active cancer؛ non-severe infection؛ and lack of crisis in the last 6 months.
The exclusion criteria of study included lack of desire to continue the intervention؛ intolerance to more round number of device and patients who find hemodynamic disorder during the intervention؛ and severe anemia (hematocrit less than 20%).
Age
From 18 years old to 68 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Mashhad University of Medical Sciences and Health Services.
Street address
street Crossroads School of Nursing and Midwifery
City
Mashhad
Postal code
Approval date
2017-03-11, 1395/12/21
Ethics committee reference number
IR.MUMS.REC.1395.612
Health conditions studied
1
Description of health condition studied
Fatigue Hemodialysis Patients
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Dimensions of fatigue in hemodialysis patients
Timepoint
before intervention, two weeks (sixth session) and four weeks (twelfth session) after the intervention
Method of measurement
Multidimensional Fatigue Inventory MFI
Secondary outcomes
1
Description
Increasing blood flow rate
Timepoint
In each session of hemodialysis
Method of measurement
With hemodialysis machine
Intervention groups
1
Description
For experimental group subjects, blood flow rate of hemodialysis device is increases in the first two weeks by 25 rounds compared to mean number of device rounds in two sessions before the start of intervention and during the second two weeks by 50 rounds compared to mentioned mean.
Category
Treatment - Other
2
Description
In the control group, the mean number of rounds of device is set on same mean round of two sessions before intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital Dialysis Center
Full name of responsible person
Hossein Kakhki
Street address
City
Mashhad
2
Recruitment center
Name of recruitment center
Shafa Dialysis Center
Full name of responsible person
Hossein Kakhki
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University Of Medical Sciences And Health Services.
Full name of responsible person
Dr Saeed Islami
Street address
Building Qureshi, Street Daneshgah
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University Of Medical Sciences And Health Services.
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
Mashhad University Of Medical Sciences
Full name of responsible person
Hossein Kakhki Gaghargh
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
unit 2, Plaque18, Corner Mohammedia 5/5, Elahiyeh
City
Mashhad
Postal code
Phone
+98 51 3524 4961
Fax
Email
kakhkih931@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Maryam Bagheri
Position
Masters
Other areas of specialty/work
Street address
pelak27, vilay6, haft tir23
City
Mashhad
Postal code
Phone
+98 51 3891 5597
Fax
Email
bagherim@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Hossein Kakhki Jaghargh
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
unit 2, Plaque18, Corner Mohammedia 5/5, Elahiyeh
City
Mashhad
Postal code
Phone
+98 51 3524 4961
Fax
Email
kakhkih931@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)