Effect of a course of aerobic training versus control group on blood factors and psychological symptoms in patients undergoing hemodialysis: a randomized clinical trial
To assess the effect of a course of aerobic training versus control group on blood factors and psychological symptoms in patients undergoing hemodialysis
Design
This is a randomized clinical trial with a control group with parallel groups without blinding, in which 40 eligible patients will be randomly assigned to the intervention and control groups using drawing of lots.
Settings and conduct
This study will be conducted at the Beheshti Hospital in Hamadan city, involving 40 eligible patients undergoing hemodialysis. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. Blinding is not feasible in this trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Patients undergoing hemodialysis,
Exclusion criteria:
Movement disorders
Intervention groups
Intervention group:
Treatment and routine care for hemodialysis patients, along with aerobic exercises including pedaling on a stationary mini electric bike for 30 minutes, and resistance exercises including leg raises (two sets of 10 repetitions), heel raises (three sets of 15 repetitions), and knee flexion and extension (two sets of 10 repetitions), performed three days per week for three months.
Control group:
Treatment and routine care for hemodialysis patients
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
recruiting
Funding source
Expected recruitment start date
2026-05-31, 1405/03/10
Expected recruitment end date
2026-09-01, 1405/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a course of aerobic training versus control group on blood factors and psychological symptoms in patients undergoing hemodialysis: a randomized clinical trial
Public title
Effect of a course of aerobic training versus control group on blood factors and psychological symptoms in patients undergoing hemodialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years,
Patients undergoing hemodialysis,
Exclusion criteria:
Movement disorders
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to intervention and control groups by lottery. For this purpose, we prepare two sheets, write "intervention" on one and "control" on the other. Then, with each patient's visit, one of the sheets is randomly taken and the patient is assigned to the intervention or control group.
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 of Islamic Azad University – Boroujerd Branch
Street address
Islamic Azad University, Borujerd Branch, Navab Square
City
Boroujerd
Province
Lorestan
Postal code
6915136111
Approval date
2026-04-22, 1405/02/02
Ethics committee reference number
IR.IAU.B.REC.1405.018
Health conditions studied
1
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.31
ICD-10 code description
Encounter for adequacy testing for hemodialysis
Primary outcomes
1
Description
Blood calcium level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
2
Description
Blood phosphorus level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
3
Description
Blood sodium level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
4
Description
Blood potassium level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
5
Description
Blood hemoglobin level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
6
Description
Blood hematocrit level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
7
Description
Blood platelet level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
8
Description
Blood creatinine level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
9
Description
Blood urea level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
10
Description
Blood albumin level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
11
Description
Blood triglyceride level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
12
Description
Blood cholesterol level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
13
Description
Blood alkaline phosphatase level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
14
Description
Blood SGOT level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
15
Description
Blood SGPT level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
16
Description
Blood parathyroid hormone level
Timepoint
Before the intervention and three months later
Method of measurement
By taking and testing a blood sample
17
Description
Psychological symptoms
Timepoint
Before the intervention and three months later
Method of measurement
Using the Garnefski standard questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment and routine care for hemodialysis patients, along with aerobic exercises including pedaling on a stationary mini electric bike for 30 minutes, and resistance exercises including leg raises (two sets of 10 repetitions), heel raises (three sets of 15 repetitions), and knee flexion and extension (two sets of 10 repetitions), performed three days per week for three months.
Category
Other
2
Description
Control group: Treatment and routine care for hemodialysis patients
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital in Hamadan city
Full name of responsible person
Fahimeh Ghodrati
Street address
Beheshti Hospital, Eram Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0283
Email
fahimeghoratii@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Ali Aryapoor
Street address
Islamic Azad University, Borujerd Branch, Navab Square
City
Boroujerd
Province
Lorestan
Postal code
6915136111
Phone
+98 66 4251 8000
Email
info.research@IAU.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Fahimeh Ghodrati
Position
Student of Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Islamic Azad University, Borujerd Branch, Navab Square,
City
Boroujerd
Province
Lorestan
Postal code
6915136111
Phone
+98 66 4251 8000
Email
fahimeghoratii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Mehdi Roozbahani
Position
Specialist in Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Islamic Azad University, Borujerd Branch, Navab Square,
City
Boroujerd
Province
Lorestan
Postal code
6915136111
Phone
+98 66 4251 8000
Email
mehdi.roozbahani@iau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available