The effect of a long-term period interval and continuous exercise on some markers and inflammatory cytokines in breast cancer survivors
Design
45 women breast cancer survivors will be randomly divided into three groups (high intensity interval training, moderate intensity continuous training, and control). Each group will perform its own training protocol. Pre-test and post-test blood samples will be taken from the subjects to measure biochemical values.
Settings and conduct
The location of the research will be Tehran and the Laboratory of Sport Physiology.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1. A definitive diagnosis of cancer and a history of cancer based on medical records 2. Exposure to stage one, two or three diseases and completion of treatment courses (Breast Removal Surgery, Chemotherapy, Radiotherapy) at least in the last 6 months 3.Menopause 4.Body mass index more than 25 kg/m2 5.Body fat more than 30%. Exclusion criteria:1.Cardiovascular disease 2.Diabetes 3.Thyroid diseases 4.smoking
Intervention groups
Control, high intensity interval training, moderate intensity continuous training
Main outcome variables
Effect of high intensity interval training and moderate intensity continuous training on IL-8؛ Leptin؛ Adiponectin؛ IGF-1؛ IGFBP-3؛ TAC؛ MDA؛ OHdG-8
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190731044398N2
Registration date:2019-09-05, 1398/06/14
Registration timing:registered_while_recruiting
Last update:2019-09-05, 1398/06/14
Update count:0
Registration date
2019-09-05, 1398/06/14
Registrant information
Name
Babak Hooshmand Moghadam
Name of organization / entity
Ferdowsi University of Mashhad
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 0540
Email address
babak.hooshmand@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a long-term period interval and continuous exercise on some markers and inflammatory cytokines in breast cancer survivors
Public title
The effect of a long-term period interval and continuous exercise on some markers and inflammatory cytokines in breast cancer survivors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
A definitive diagnosis of cancer and a history of cancer based on medical records.
Exposure to stage one, two or three diseases and completion of treatment courses (Breast Removal Surgery, Chemotherapy, Radiotherapy) at least in the last 6 months
Menopause
Body mass index more than 25 kg/m2
Body fat more than 30%
Randomization method: Simple randomization, randomization unit: individual, randomization tool: random number table
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
Research Ethics Committee of Physical Education and Sport Sciences
Street address
impasse 5, district 7, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.SSRI.REC.1398.055
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Serum levels of IL-8
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method
2
Description
Serum levels of Leptin
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method
3
Description
Serum levels of Adiponectin
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method
4
Description
Serum levels of IGF-1
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method
5
Description
Serum levels of IGFBP-3
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method
6
Description
Serum levels of TAC
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method
7
Description
Serum levels of MDA
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method
8
Description
Serum levels of 8-OHdG
Timepoint
Before and after intervention
Method of measurement
Blood sampling and using ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
high intensity interval training group: During the study, this group will perform high intensity interval training for 12 weeks and 3 weeks each week.
Category
Rehabilitation
2
Description
moderate intensity continuous training group: During the study, this group will perform moderate intensity continuous training for 12 weeks and 3 weeks each week.
Category
Rehabilitation
3
Description
Control group: During the study, this group will not perform any exercise.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Private
Full name of responsible person
Babak Hooshmand Hoghadam
Street address
Faculty of Physical Education and Sport Science of Tehran University, Northern Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
b.hooshmand.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Private
Full name of responsible person
Babak Hooshmand Moghadam
Street address
Faculty of Physical Education and Sport Science of Tehran University, Northern Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
b.hooshmand.m@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Private
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Parisa Pournemati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, Tehran University , North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
p.pournemati@ut.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Parisa Pournemati
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, Tehran University , North Kargar Ave, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
p.pournemati@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Babak Hooshmand Moghadam
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, Northern Kargar Ave
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
b.hooshmand.m@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Personal information of patients is confidential. But access to the research method and the information obtained from the research is not a problem
When the data will become available and for how long
After printing in a journal
To whom data/document is available
All students and enthusiasts
Under which criteria data/document could be used
In order to use data to carry out research work in this area
From where data/document is obtainable
The authors of this article b.hooshmand.m@gmail.com
What processes are involved for a request to access data/document
By sending email the author will work with the applicant as soon as possible