Objectives: To assess the effect of physical exercise versus no exercise on blood parameters in hemodialysis patients
Design: A randomized clinical trial.
Setting and conduct: The eligible hemodialysis patients who will refer to Besat Hospital during the study period will be enrolled into the trial.
Inclusion criteria: (a) age of 18 to 65 years; (b) history of hemodialysis for at least 3 months; (C) serum ferritin level between 200 to 400 ng/dl.
Exclusion criteria: (a) not participating in the program for 2 consecutive sessions or three sequential sessions; (b) need to kidney transplantation; (c) hiving cardiovascular diseases or musculoskeletal disorders; (d) history of cerebral ischemia during the last 3 months; (e) contraindication for physical activity.
Intervention group: Routine hemodialysis plus physical activity 3 sessions a week for 4 weeks.
Control group: Routine hemodialysis alone without physical activity.
Primary outcome: (a) assessing the RBC before and one month after beginning of intervention through laboratory techniques; (b) assessing the WBC before and one month after beginning of intervention through laboratory techniques; (c) assessing the hemoglobin before and one month after beginning of intervention through laboratory techniques; (d) assessing the hematocrit before and one month after beginning of intervention through laboratory techniques; (e) assessing the platelet before and one month after beginning of intervention through laboratory techniques; (f) assessing the BUN before and one month after beginning of intervention through laboratory techniques; (g) assessing the creatinine before and one month after beginning of intervention through laboratory techniques.
Secondary outcome: Nothing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506139014N69
Registration date:2015-06-18, 1394/03/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-18, 1394/03/28
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-06-21, 1394/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of physical exercise versus no exercise on blood parameters in hemodialysis patients: a randomized clinical trial
Public title
Effect of physical exercise versus no exercise on blood parameters in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) age of 18 to 65 years; (b) history of hemodialysis for at least 3 months; (C) serum ferritin level between 200 to 400 ng/dl.
Exclusion criteria: (a) not participating in the program for 2 consecutive sessions or three sequential sessions; (b) need to kidney transplantation; (c) hiving cardiovascular diseases or musculoskeletal disorders; (d) history of cerebral ischemia during the last 3 months; (e) contraindication for physical activity.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups through drawing lot.
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-05-23, 1394/03/02
Ethics committee reference number
IR.UMSHA.REC.1394.48
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.1
ICD-10 code description
Extracorporeal dialysis
Primary outcomes
1
Description
assessing the RBC
Timepoint
before and one month after beginning of intervention
Method of measurement
through laboratory techniques
2
Description
assessing the WBC
Timepoint
before and one month after beginning of intervention
Method of measurement
through laboratory techniques
3
Description
assessing the hemoglobin
Timepoint
before and one month after beginning of intervention
Method of measurement
through laboratory techniques
4
Description
assessing the hematocrit
Timepoint
before and one month after beginning of intervention
Method of measurement
through laboratory techniques
5
Description
assessing the platelet
Timepoint
before and one month after beginning of intervention
Method of measurement
through laboratory techniques
6
Description
assessing the BUN
Timepoint
before and one month after beginning of intervention
Method of measurement
through laboratory techniques
7
Description
assessing the creatinine
Timepoint
before and one month after beginning of intervention
Method of measurement
through laboratory techniques
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Routine hemodialysis plus physical activity 3 sessions a week for 4 weeks
Category
Other
2
Description
Routine hemodialysis alone without physical activity
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Ali Nezamloo
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
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 the Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Ali Nezamloo
Position
Intensive Care Student
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3264 0020
Fax
Email
nezamlo.ali@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Dr Khodayar Oshvandi
Position
Nursing PhD
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3264 0020
Fax
Email
oshvandi2005@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)