Determination and comparison of intradialysis exercise on quality of life and recovery time of hemodialysis patients
Design
A non blinded, parallel group , randomized with random number, controlled clinical trial with a parallel group design of 58 patients between November 2019 and February 2020
Settings and conduct
58 hemodialysis patients in Alzahra & Khorshid hospitals work with Minibike in second hour of dialysis for 30 minutes after training. Before study and after 3 months of study, quality of life questioner and recovery time is filled. Iron storage values, lipid profile and albumin are measured in beginning and after completion of study. in control group, questionnaire and laboratory values are filled.
Participants/Inclusion and exclusion criteria
At least 3 months hemodialysis patients that agree to participate to cooperation with absence of chest pain, systemic blood pressure less than 180/110 mmHg . absence of vascular complications, absence of distal vascular access arrived in study. If they have dyspnea or fever more than 38 degree or chest pain during hemodialysis are excluded.
Intervention groups
Study group: exercise during second hours of dialysis with minibike for 30 minute
Control group: without exercise
Main outcome variables
quality of life score؛ recovery time؛ Iron storage changes؛ lipid profile changes؛ albumin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090905002417N22
Registration date:2019-11-25, 1398/09/04
Registration timing:prospective
Last update:2019-11-25, 1398/09/04
Update count:0
Registration date
2019-11-25, 1398/09/04
Registrant information
Name
Firouzeh Moeinzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1625 5555
Email address
moinzade@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of intradialysis exercise in quality of life and time of recovery in patients on hemodialysis
Public title
the effect of intradialysis exercise on hemodialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hemodialysis at least 3 months
Interesting to study cooperation
Has not amputation in lower limb
Has not musculoskletal problems like rheumatologic disorders, limb trauma
Exclusion criteria:
Systemic blood pressure more than 180/110
Presence of chest pain
Dyspnea during hemodialysis
Fever more than 38 degree during hemodialysis
Lower limb vascular access
Age
From 18 years old to 90 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization, individual with random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research, Isfahan University of Medical Sciences
Street address
Hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
IR.MUI.MED.REC.1398.368
Health conditions studied
1
Description of health condition studied
Effect of intradialysis exercise on quality of life and recovery time
ICD-10 code
N18.6
ICD-10 code description
End stage renal disease
Primary outcomes
1
Description
Quality of life score
Timepoint
Before exercise and 3 months after
Method of measurement
SF-KDQOL questioner
2
Description
Recovery time
Timepoint
Before exercise and 3 months later
Method of measurement
Question
Secondary outcomes
1
Description
Serum iron level
Timepoint
Before exercise and 3 months later
Method of measurement
Laboratory kit ELISA
2
Description
Ferritin
Timepoint
Before and 3 months later
Method of measurement
Laboratory kit ELISA
3
Description
Total iron binding capacity
Timepoint
Before exercise and 3 months later
Method of measurement
Laboratory kit ELISA
4
Description
Triglyceride
Timepoint
Before exercise and 3 months later
Method of measurement
Laboratory kit ELISA
5
Description
Total cholesterol
Timepoint
Before exercise and 3 months later
Method of measurement
Laboratory kit ELISA
6
Description
Albumin
Timepoint
Before exercise and 3 months later
Method of measurement
Laboratory kit ELISA
Intervention groups
1
Description
Intervention group: intradialysis exercise in second hour of dialysis for half of hour via Minibike manufactured by Taiwan
Category
Treatment - Devices
2
Description
Control group: hemodialysis patients without exercise
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Safoura Shahzeidi
Street address
Sofe street
City
Isfahan
Province
Isfehan
Postal code
81764675731
Phone
+98 31 3822 2268
Email
saf3270@yahoo.com
2
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Safoura Shahzeidi
Street address
Ostandari street
City
Isfahan
Province
Isfehan
Postal code
8135673381
Phone
+98 31 3222 2127
Email
saf3270@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjooy Javanmard
Street address
Hezar Jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@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
Dr Firouzeh Moeinzadeh
Position
Assistant Professor of Nephrology
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Alzahra Hospital, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 1668 5555
Fax
Email
f_moinzade@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Sofe street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 6713
Email
f_moinzade@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Firouzeh Moeinzadeh
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nephrology
Street address
Sofe street
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3822 6713
Email
f_moinzade@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Results of study would be available
When the data will become available and for how long
After October 2020
To whom data/document is available
Only academic institutes permit for results
Under which criteria data/document could be used
Medical Students permit
From where data/document is obtainable
via f_moinzade@med.mui.ac.ir
What processes are involved for a request to access data/document
It will response during 1 month after receiving email