The effect of high-intensity interval exercise and training on the mobilization of hematopoietic stem cells in autologous bone marrow transplant patients
The general aim of the present study was to investigate the effect of high-intensity interval exercise and training on the mobilization of hematopoietic stem cells in autologous bone marrow transplant patients.
Design
A clinical trial with a control group, with parallel groups, randomized, on 40 patients
Settings and conduct
Patients who were candidates for autologous bone marrow transplantation after inpatient in Taleghani Hospital, volunteered to participate in this study.
Participants/Inclusion and exclusion criteria
Entry requirements:
Lymphoma and multiple myeloma patients candidates for autologous bone marrow transplantation, BMI less than 30, no history of cardiovascular diseases, diabetes, autonomic disorder, kidney disease, hepatitis or lung disease, non-smokers, successful exercise test up to the fourth stage of the test, not having a movement disorder and no difficulty in exercising clinically
Non-entry conditions:
Inability to exercise according to the opinion of a specialist doctor
Intervention groups
The exercise group will exercise during the bone marrow transplant process.
The control group will receive only the usual care during the bone marrow transplant process without doing any exercise.
Main outcome variables
Increase of stem cells in peripheral blood following exercise
Improving platelet and leukocyte grafting
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230101057012N1
Registration date:2023-01-08, 1401/10/18
Registration timing:prospective
Last update:2023-01-08, 1401/10/18
Update count:0
Registration date
2023-01-08, 1401/10/18
Registrant information
Name
Tayebe Zarekar
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 0000
Email address
t_zarekar@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-10, 1401/10/20
Expected recruitment end date
2023-05-10, 1402/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high-intensity interval exercise and training on the mobilization of hematopoietic stem cells in autologous bone marrow transplant patients
Public title
The effect of exercise on the mobilization of hematopoietic stem cells
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Lymphoma and multiple myeloma patients candidates for autologous bone marrow transplantation
BMI less than 30
No history of cardiovascular disease, diabetes, autonomic disorder, kidney disease, hepatitis or lung disease
Non-smoker
Successful completion of exercise test up to the fourth stage
Not having a movement disorder and no difficulty in exercising clinically
Having a medical approval to exercise
Exclusion criteria:
Inability to do exercise based on the opinion of a specialist doctor
Age
From 18 years old to 60 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
Qualified subjects are selected for the research based on the file information and after obtaining informed consent. The website https://www.sealedenvelope.com is used for randomization and the generation of a random block sequence, and sealed opaque envelopes are used to hide the random allocation. Each of the generated random sequences is recorded on a card and the cards are placed in the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. The lid of the letter envelopes is glued and placed in a box. The participants open one of the letter envelopes and are placed in one of the groups based on it.
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 Shahid Beheshti University of Medical Sciences
Street address
Eerabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-10-10, 1400/07/18
Ethics committee reference number
IR.SBMU.REC.1400.017
Health conditions studied
1
Description of health condition studied
Lymphoma
ICD-10 code
C85.1
ICD-10 code description
Unspecified B-cell lymphoma
2
Description of health condition studied
Multiple myeloma
ICD-10 code
C90.0
ICD-10 code description
Multiple myeloma
Primary outcomes
1
Description
Mobilization of hematopoietic stem cells
Timepoint
Before and after exercise activity
Method of measurement
Counting hematopoietic stem cells with flow cytometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Performing interval exercise before apheresis
Category
Treatment - Other
2
Description
Control group: Without physical activity before apheresis
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hos[ital
Full name of responsible person
Tayebe Zarekar
Street address
Eerabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2560
Email
taleghani@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Eerabi Ave, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://msp.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
50
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
Shahid Beheshti University
Full name of responsible person
Tayebe Zarekar
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Postal code: 1983969411, Shahid Shahriari square, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 0000
Fax
Email
t_zarekar@sbu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Tayebe Zarekar
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Postal code: 1983969411, Shahid Shahriari square, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 0000
Fax
Email
t_zarekar@sbu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Tayebe Zarekar
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
Postal code: 1983969411, Shahid Shahriari square, Evin
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 0000
Fax
Email
t_zarekar@sbu.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
Data from this study and supplemental information will be available upon request after de-identifying participants' personal information.
When the data will become available and for how long
Data from the current study will be available immediately after publication.
To whom data/document is available
Data from this study and supplementary information will be available to both those working in academic and academic institutions, as well as those working in business, trade, and industry, whenever they request it.
Under which criteria data/document could be used
Data from this study and supplementary information will be publicly available. However, those who wish to use them must respect copyright, not manipulate them, and cite the original study articles that will be published.
From where data/document is obtainable
The raw data and supporting information for this study will be available without reservation upon request from the corresponding author. The author is Tayebe Zarekar from the Department of Biological Sciences in Sports, Faculty of Sports and Health Sciences, Shahid Beheshti University, Valenjak, Tehran, Iran. Email: t_zarekar@sbu.ac.ir. Postal code: 1983963113
What processes are involved for a request to access data/document
The raw data and supporting information of this study will be available up to three weeks after their request.