Objective: To determine the effect of a combination of sixteen weeks of training on the risk factors associated with coronary-kidney syndromes in patients undergoing hemodialysis. Design: The study group composed of 45 dialysis patients, which will be divided randomly into intervention and control groups. Setting and conduct: The basic amounts of fibroblast growth factor 23 (FGF23), Fetuin A and reactive protein C (CRP) will be measured in all subjects. For the intervention group during dialysis concurrent training for four months is offered. Then, to measure changes in blood factors second blood samples will be taken. Participants: inclusion criteria included adults with renal failure who are on dialysis for at least six months and exclusion criteria of the study included patients who smoke or cannot do exercises. Intervention: Combined activities including aerobic and resistance exercises, three times a week for sixteen weeks. The main outcome variables: the amount of FGF23, Fetuin A and CRP in both groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201106092858N5
Registration date:2015-08-22, 1394/05/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-22, 1394/05/31
Registrant information
Name
Hamid Taieby Khosroshahy
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 3966
Email address
khosroshahyh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University Of Medical Sciences
Expected recruitment start date
2015-02-01, 1393/11/12
Expected recruitment end date
2015-05-23, 1394/03/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of 16 week combined training on cardio-renal syndrome risk factors in hemodialysis patients
Public title
exercise effects on cardio-renal syndrome risk factors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: kidney patients; dialysis; the ability to exercise
exclusion criteria: inability to exercise; smoking
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The classification to the exercise and control groups was assigned by the sealed envelope
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Daneshgah Ave. Tabriz, East Azarbaijan Province
City
Tabriz
Postal code
Approval date
2015-03-02, 1393/12/11
Ethics committee reference number
5/4/12126
Health conditions studied
1
Description of health condition studied
kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
FGF23
Timepoint
befor and after 16 week of exercise
Method of measurement
ELISA kit
2
Description
Fetuin A
Timepoint
befor and after 16 week of exercise
Method of measurement
ELISA kit
3
Description
Crp
Timepoint
befor and after 16 week of exercise
Method of measurement
ELISA kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Performing 16 weeks of combined training exercise including aerobic and resistance training, which includes cycling and four leg movements while weights added to the leg. Cycling for 20 minutes or more and three sets of resistance training.
Category
N/A
2
Description
control group: any exercise is given- no exercise
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital
Full name of responsible person
Roughayeh Fakhrpour
Street address
Shahid Madani Hospital, Daneshgah St.,Tabriz
City
Tabriz
2
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Roughayeh Fakhrpour
Street address
Sina Hospital, Azadi St.,Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Third floar,Second building of Tabriz University of Medical Sciences,Gholgasht ave. Tabriz, East Azarbaijan Provice
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz University of Medical Sciences
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
Azarbaijan Shahid Madani University
Full name of responsible person
Roughayeh Fakhrpour
Position
Faculty member, Phd student
Other areas of specialty/work
Street address
35 th kilometer of Tabriz- Maragheh Road, Tabriz
City
Tabriz
Postal code
Phone
+98 41343275002409
Fax
Email
r.fakhrpour@yahoo.com r.fakhrpour@azaruniv.edu
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hamid Tayebi Khosroshahy
Position
Phd
Other areas of specialty/work
Street address
Emam Reza Hospital,Daneshgah ave. Tabriz
City
Tabriz
Postal code
Phone
+98 41 3554 6904
Fax
Email
khosroshahyh@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Azarbaijan Shahid Madani University
Full name of responsible person
Yousef Yavari
Position
Faculty member, Phd
Other areas of specialty/work
Street address
35 th kilometers of Tabriz - Maragheh Road, Tabriz
City
Tabriz
Postal code
Phone
+98 41343275002404
Fax
Email
yavarif@yahoo.com yavarif@azaruniv.edu
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)