The effect of 12 weeks of continuous moderate training on biomarkers of oxidative stress and DNA damage in women rescued from breast cancer
Design
The present study was an applied and quasi-experimental study that was performed in two intervention groups and one control group
Randomization Method: Simple Randomization, Randomization Unit: Individual, Randomization Tool: Random Number Table
was performed on 30 postmenopausal women
Settings and conduct
This study examined the effect of 12 weeks of moderate-intensity continuous exercise on stress biomarkers in women rescued from breast cancer.This research is a quasi-experimental method that will be performed in an intervention group and a control group.The statistical population of this study includes postmenopausal women after at least six months of terminaion of their treatment for breast cancer. The moderate-intensity continuous exercise group performed exercise for 12 weeks (36 sessions). Each training session is performed using an ergometer Monark 894E for 20-30 minutes and under the full supervision of the physician.The control group did not perform any exercise intervention.Address: (Nutrition Clinic) No.68, Gulfam Alley, Nelson Mandela Street,Tehran
Participants/Inclusion and exclusion criteria
Admission requirements: 1. Definitive diagnosis of the disease and the history of cancer based on the records in the medical record. Placement in stage one, two or three diseases and completion of treatment courses (breast resection surgery, chemotherapy, radiation therapy) for at least the last 6 months. Menopause 4. Body mass index more than 25 kg per square meter 5. Body fat more than 30%. Exclusion criteria: 1. Cardiovascular diseases 2. Diabetes 3. Thyroid diseases 4. smoking
Intervention groups
Continuous training group of 15 people and control group of 15 people
Main outcome variables
oxidative stress biomarkers:GPX,SOD,TAC,8-OHdG
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220418054577N1
Registration date:2022-05-14, 1401/02/24
Registration timing:registered_while_recruiting
Last update:2022-05-14, 1401/02/24
Update count:1
Registration date
2022-05-14, 1401/02/24
Registrant information
Name
Sahabeh Mahdian
Name of organization / entity
University of tehran(physical education and sport)
Country
Iran (Islamic Republic of)
Phone
+98 21 8860 9716
Email address
sahabeh_mahdiann@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-04, 1401/02/14
Expected recruitment end date
2022-06-04, 1401/03/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 12 weeks of continuous moderate training on oxidative stress and DNA damage in breast cancer survivors
Public title
The effect of continuous moderate training on oxidative stress and DNA damage in breast cancer survivors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
at least 6 months of complete discontinuation of breast cancer treatment
permission of the physician to participating in the research
women should be on the same levele in terms of health،life ، nutrition ،duration of illness
body mass index shoul be above 25kg/m2.weight of body fat more than 30%
ability to exercise with the approval of an oncologist and cardiologist
menopause
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
Sports Science Research Institute(the Institute of Physical Education and Sports Sciences)
Street address
Tehran - Ostad Motahhari St. - Mir Emad St. - Fifth Alley - No. 3
City
tehran
Province
Tehran
Postal code
1587958711
Approval date
2021-12-19, 1400/09/28
Ethics committee reference number
IR.UT.SPORT.REC.1400.036
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 SOD levels
Timepoint
48 hours before and after the desired interventions
Method of measurement
Blood sampling using ELISA method
2
Description
Serum GPX levels
Timepoint
48 hours before and after the desired interventions
Method of measurement
Blood sampling using ELISA method
3
Description
Serum TAC levels
Timepoint
48 hours before and after the desired interventions
Method of measurement
Blood sampling using ELISA method
4
Description
Serum MDA levels
Timepoint
48 hours before and after the desired interventions
Method of measurement
Blood sampling using ELISA method
5
Description
Serum 8-OHdg levels
Timepoint
48 hours before and after the desired interventions
Method of measurement
Blood sampling using ELISA method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Medium intensity continuous training: During the research, this group will perform three sessions of moderate intensity continuous training for 12 weeks and a week. All aspects of this study are in line with the basic principles of the Helsinki Declaration. The present study is an applied and quasi-experimental method that is performed in an intervention group and a control group. The statistical population of this study includes 30 postmenopausal women after at least six months of termination of their treatment for breast cancer. After the initial assessments, the subjects are randomly divided into two groups of 15 people with continuous training and the control group. The subjects of the training group are subjected to sports intervention for 12 weeks. Each training session is performed using the Ergometer Monark 894E bicycle for 20-30 minutes and under the full supervision of the instructor and physician. At each training session, subjects' heart rate information is monitored by a Finnish-made Polar heart rate monitor and the exercise pressure perception rate (Borg scale RPE scale 6 to 20) is monitored and recorded regularly throughout the time.
Category
Rehabilitation
2
Description
Control group:The control group consists of 15 postmenopausal women who are followed during this period and do not do any sports intervention and only continue their daily activities and routine medical care.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
clinic of nutrition
Full name of responsible person
sahabeh mahdian
Street address
Raden. Jordan St., Gulfam Alley, No. 68 (Doctors Building) Gulfam, Unit 7
City
tehran
Province
Tehran
Postal code
1915673499
Phone
+98 21 2621 6051
Email
sahabeh_mahdiann@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
by myself
Full name of responsible person
sahabeh mahdian
Street address
Unit 7, No.11, Baharan St., Shiraz-South St, Mollasadra St, Vanak Sq, Tehran
City
tehran
Province
Tehran
Postal code
1435814118
Phone
+98 21 8860 9716
Email
sahabeh_mahdiann@yahoo.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
Faculty of Physical Education and Sport Sciences - University of Tehran
Full name of responsible person
parisa pournemati
Position
lecture university
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, Tehran, North Kargar St., 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
Faculty of Physical Education and Sport Sciences, University of Tehran
Full name of responsible person
Parisa pournemati
Position
lecture university
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, Iran, Tehran, North Kargar St.tehran. iran
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
1417614418
Email
p.pournemati@ut.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Physical Education and Sport Sciences - University of Tehran
Full name of responsible person
Sahabeh Mahdian
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Faculty of Physical Education and Sport Sciences, University of Tehran, Iran, Tehran, North Kargar St.
City
Tehran
Province
Tehran
Postal code
1417614418
Phone
+98 21 8835 1730
Email
sahabeh_mahdiann@yahoo.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
Patients' personal information is confidential. But access to research methods and information obtained from research is not an obstacle
When the data will become available and for how long
Access period starts 6 months after the results are published "
To whom data/document is available
All students and enthusiasts
Under which criteria data/document could be used
To use the data to conduct research in this area
From where data/document is obtainable
Authors of this article: sahabeh_mahdiann@yahoo.com
What processes are involved for a request to access data/document
By sending an email to the author will cooperate with the applicant at the earliest opportunity