Protocol summary
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Study aim
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The effect of 12 weeks continuous moderate training and High intensity interval training on biomarkers of oxidative stress and DNA damage in women rescued from breast cancer
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Design
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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 45 postmenopausal women
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Settings and conduct
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This research is a quasi-experimental method that will be performed in two 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. Two groups of continuous exercise with moderate intensity and intermittent exercise with high intensity 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
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Participants/Inclusion and exclusion criteria
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Admission requirements: 1. Definitive diagnosis of the disease and the history of cancer based on the records. 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
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Intervention groups
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Continuous training group of 15 people and interval training group of 15 people and control group of 15 people
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Main outcome variables
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oxidative stress biomarkers:GPX,SOD,TAC,8-OHdG
General information
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Reason for update
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Change the title of the article and Adding interval training to the training protocol
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220418054577N1
Registration date:
2022-05-14, 1401/02/24
Registration timing:
prospective
Last update:
2022-08-17, 1401/05/26
Update count:
1
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Registration date
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2022-05-14, 1401/02/24
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-22, 1401/05/31
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Expected recruitment end date
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2022-09-20, 1401/06/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of 12 weeks of continuous training and Interval training on oxidative stress and DNA damage in breast cancer survivors
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Public title
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The effect of 12 weeks of continuous training and Interval training on oxidative stress and DNA damage in breast cancer survivors
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
Exclusion criteria:
Cardiovascular disease
Diabetes disease
Thyroid disease
Smoking
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Age
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From 54 years old to 60 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
45
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization Method: Simple Randomization, Randomization Unit: Individual, Randomization Tool: Random Number Table
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-12-19, 1400/09/28
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Ethics committee reference number
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IR.UT.SPORT.REC.1400.036
Health conditions studied
1
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Description of health condition studied
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breast cancer
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ICD-10 code
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C50
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ICD-10 code description
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Malignant neoplasm of breast
Primary outcomes
1
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Description
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Serum SOD levels
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Timepoint
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48 hours before and after the desired interventions
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Method of measurement
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Blood sampling using ELISA method
2
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Description
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Serum GPX levels
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Timepoint
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48 hours before and after the desired interventions
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Method of measurement
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Blood sampling using ELISA method
3
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Description
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Serum TAC levels
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Timepoint
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48 hours before and after the desired interventions
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Method of measurement
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Blood sampling using ELISA method
4
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Description
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Serum MDA levels
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Timepoint
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48 hours before and after the desired interventions
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Method of measurement
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Blood sampling using ELISA method
5
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Description
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Serum 8-OHdg levels
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Timepoint
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48 hours before and after the desired interventions
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Method of measurement
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Blood sampling using ELISA method
Intervention groups
1
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Description
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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 two interventions group and a control group. The statistical population of this study includes 45 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 three groups of 15 people with continuous training and interval training and the control group. The subjects of the continuous training 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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Lifestyle
3
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Description
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Intervention group: High intensity interval training:During the research, this group will perform three sessions of high-intensity interval training for 12 weeks.All aspects of this study are in accordance with the basic principles of the Declaration of Helsinki. The current research is applied and semi-experimental in two intervention groups and one control group. The statistical population of this research includes 45 menopausal women after at least six months of breast cancer treatment. After the initial evaluations, the subjects are randomly divided into three groups of 15 people: continuous exercise, intermittent exercise group, and control group.Each exercise session is done using an ergometer Monark 894E bicycle for 20-30 minutes under the full supervision of a trainer and doctor. In each training session, the subject's heart rate information is recorded regularly by means of Polar heart rate monitor made in Finland and the level of perception of training pressure (by Borg RPE scale 6 to 20) during the entire monitoring time. The main training in this group is in At first (the first week), there were four training stages (30 seconds of pedaling and 2 active rests) in a row. The number of steps increases every week until it reaches 7 steps in the fourth week (one step was added every week until the fourth week), from the fourth week to the 12th week, the number of steps is maintained at the same number (7 steps).
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Private
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Patients' personal information is confidential. But access to research methods and information obtained from research is not an obstacle
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When the data will become available and for how long
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Access period starts 6 months after the results are published "
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To whom data/document is available
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All students and enthusiasts
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Under which criteria data/document could be used
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To use the data to conduct research in this area
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From where data/document is obtainable
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Authors of this article: sahabeh_mahdiann@yahoo.com
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What processes are involved for a request to access data/document
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By sending an email to the author will cooperate with the applicant at the earliest opportunity
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Comments
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