The Illumination of The Effect of Eight-Week Concurrent Training on Expression of P53 and P21 Tumor Suppressor Genes in Men with Prostate Cancer.
Design
this research is a clinical trial that the subjects were compared to experimental and control groups and randomly divided into two groups of 10 control and experimental groups without Blinding.
Settings and conduct
This research can be done by referring to the pathology department of Baqiyatallah El - Azam Subspeciality Hospital and reviewing the medical records of men with prostate cancer.
Participants/Inclusion and exclusion criteria
The entering criteria for the study include: Physical health based on a medical history questionnaire, no smoking and no participation in any training's program at least 2 months before take part In the training's program of this research and subjects after the cardiovascular's examination, blood pressure measurements and electrocardiogram recording by a specialist, getting to permit a log in the plan and get informed consent form in this research by the subjects.
Exclusion criteria include: Not attending more than 3 sessions, having heart disease or pulmonary disease, and change in the health status that prevents physical activity.
Intervention groups
The control group will continue to carry out regular daily activities.
Experimental group subjects included the exercise protocol: concurrent training course (aerobic-resistance) that designed by the researcher, for three days a week for 8 weeks. Resistance training at 60-75% intensity of one repeatation maximal and aerobic exercise at 60-75% maximum heart rate will be done.
Main outcome variables
aerobic capacity؛ p53؛ p21
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171128037667N1
Registration date:2018-04-28, 1397/02/08
Registration timing:registered_while_recruiting
Last update:2018-04-28, 1397/02/08
Update count:0
Registration date
2018-04-28, 1397/02/08
Registrant information
Name
Mohammad Asghari rekabdarkolaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4321 7126
Email address
asghari.moh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eight-Week Concurrent Training on Expression of P53 and P21 Tumor Suppressor Genes in Men with Prostate Cancer
Public title
The Effect of Eight-Week Concurrent Training on Expression of Tumor Suppressor Genes in Men with Prostate Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects are putted at the stage T1 and T2 of the disease and are treated under the same way.
The entering criteria for the study include: Physical health based on a medical history questionnaire that has no history of cardiovascular disease, high blood pressure, diabetes, renal disease, no smoking or participation in any exercise program at least 2 months before take part in Exercise Training program
Subjects get allowed to enter the project after a cardiovascular examination, blood pressure measurement and ECG monitoring by a specialist.
Take The Physical activities readiness questionnaire (PAR-Q) and The informed consent form for participation in this research by subjects.
Exclusion criteria:
Not attending more than 3 sessions
having of heart or lung disease
Change in health that prevent physical activity
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
due to the health status and acceptance of the patients to the testing stages, use the selection method the maximum sample in the Morgan table, 20 men aged 51-75 years old and BMI of 23-29 kg / m2 randomly divided in to two groups of 10 Control unit and experimental.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Before the intervention and the end of the intervention
Method of measurement
Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.
2
Description
P21 tumor suppressor protein
Timepoint
Before the intervention and the end of the intervention
Method of measurement
Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.
3
Description
Aerobic capacity
Timepoint
Before the intervention and the end of the intervention
Method of measurement
To estimate the maximum oxygen consumption, the Modified Bruce test on the treadmill [based on the maximum oxygen consumption equation: 8.545 + (test run time×2.282)]
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Experimental group with practice protocol contain a concurrent training course (aerobic-resistance) that designed by the researcher (according to the American College of Medicine-Sports) for three days a week for 8 weeks. The Concurrent training program combines endurance training and resistance training that runs in two equal time steps which includes 55 minutes of training in the first and second weeks to 70 minutes in the seventh and eighth weeks. Warm up for 10 minutes Then Resistance training program included four movements of upper and lower large muscle groups that will be excuted three session per week with a severity of 60 to 75%, one repetition maximum, and for two time with 10 repetitions and three-minute break between turns. The beginning of the course with 60% of maximal repetition that increases by five percent every two weeks. Aerobic exercise with 15 minutes of activity with 60% heart rate maximum, starting at three sessions per week, which is performed with resistance training in one session. [based on the maximum heart rate equation: [(220-years)±10]. Starting The course with 60% maximum heart rate will be added every two weeks 5% to this amount and Five minutes to period. At the end of each exercise session, 10 minutes recovery to original state and cool down (slow running, walking and tensile movements for recovery) will be done.
Category
Rehabilitation
2
Description
Control group: The control group will continue to perform its daily activities and was requested to no participate in exercise training during this period.