Protocol summary

Study aim
The Impact of concurrent (aerobic-resistance) training on serum levels of IGF-BP3, IGF-1-, PTEN and SHBG in men with prostate cancer
Design
This research is clinical trial that subjects were compared to experimental and control groups and randomly divided into two groups of 10 control groups and experimental without Blinding.
Settings and conduct
In Baqiyatallah University of Medical Sciences twenty men with prostate cancer randomly will be divided as control and training groups. Training group will perform eight weeks concurrent training . At the beginning and the end of the period, blood samples will be taken in dose of 5 ml to measure serum levels of IGF-I and IGFBP-3.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Subjects are putted at the stage T1 and T2 of the disease . The entering criteria for the study include: Physical health based on a medical history questionnaire. no participation in any training's program at least 2 month 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 long in the plan and get informed consent form in this research by the subjects. Exclusion criteria include:having heart disease or pulmonary disease, high blood pressure, diabetes, renal disease and smoking .
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 repetition maximal and aerobic exercise at 60-75% maximum heart rate will be done .
Main outcome variables
PTEN, IGF-1, IGFBP-3, SHBG

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180624040222N1
Registration date: 2018-11-11, 1397/08/20
Registration timing: retrospective

Last update: 2018-11-11, 1397/08/20
Update count: 0
Registration date
2018-11-11, 1397/08/20
Registrant information
Name
Abbas Jafari
Name of organization / entity
Payame Noor University
Country
Iran (Islamic Republic of)
Phone
+98 31 3261 5399
Email address
abbast_jafari@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-09, 1397/01/20
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of concurrent (aerobic-resistance) training on serum levels of IGF-I and IGFBP-3 in men with prostate cancer
Public title
The Impact of concurrent (aerobic-resistance) training on prostate cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects are putted at the stage T1 and T2 of the disease . Physical health based on a medical history questionnaire that has no history of disease. No participation in any exercise program atlast 2 month 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:
Having of heart or lung disease. Having high blood pressure. Having diabetes Having renal disease smoking
Age
From 50 years old to 75 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
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. based on sortition, odd and even numbers were selected for experimental and control groups,respectively.
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 Baqiyatallah University of Medical Sciences
Street address
Baqiyatallah EI- Azam Subspeciality Hospital, Sheikh Bahai Av, Mulla Sadra St, Vanak Sq.
City
Tehran
Province
Tehran
Postal code
1435915371
Approval date
2016-08-01, 1395/05/11
Ethics committee reference number
IR.BMSU.REC.1395.17

Health conditions studied

1

Description of health condition studied
Prostate cancer
ICD-10 code
DO7.5
ICD-10 code description
Carcinoma in situ of prostate

Primary outcomes

1

Description
Phosphatase and tensin homolog (PTEN)
Timepoint
Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training).
Method of measurement
Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.

2

Description
Insulin-like growth factor 1 (IGF-1)
Timepoint
Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training).
Method of measurement
Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.

3

Description
Insulin-like growth factor-binding protein 3
Timepoint
Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training).
Method of measurement
Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.

4

Description
Sex hormone-binding globulin (SHBG)
Timepoint
Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training).
Method of measurement
Blood samples will be collected 24 hours before the training starts and 48 hours after the last exercise session.

5

Description
Aerobic capacity
Timepoint
Before the intervention (Before the 8 week concurrent (aerobic-resistance) training) and the end intervention(after the 8 week concurrent (aerobic-resistance) training).
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: Intervention group with practice protocol contain a concurrent training course ( aerobic-resistance ) that designed by the researcher( according to the American College of Sports Medicine ) 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 minute then resistance training program included four movements of upper and lower large muscle groups that will be executed 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 repetitions that increases bye five percent every two weeks. Aerobic training with 15 minutes of activity with 60% heart rate maximum, starting at three session per week, which is performed with resistance training in one session.[ based on the maximum heart rate will be added every two weeks 5% to this a amount and five minute to period. at the end of each exercise session , 10 minute 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 carry out regular daily activities and there was no intervention in them.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah EI- Azam Subspeciality Hospital
Full name of responsible person
Kambiz Hesrak.
Street address
Baqiyatallah EI- Azam Subspeciality Hospital, Sheikh Bahai Av, Mulla Sadra St, Vanak Sq,Tehran.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
P_Ghdian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholam Hossein Alishiri
Street address
Baqiyatallah EI- Azam Subspeciality Hospital, Sheikh Bahai Av, Mulla Sadra St, Vanak Sq,Tehran.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
P_Ghdian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah University of Medical Sciences
Proportion provided by this source
100
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Alireza Ghadian
Position
associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Baqiyatallah EI- Azam Subspeciality Hospital, Sheikh Bahai Av, Mulla Sadra St, Vanak Sq,Tehran.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 8805 0435
Email
P_Ghdian@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Hamid arazi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
University of Guilan, Postal Code 4199613776, Khalij Fars highway (5th km of Ghazvin road).
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13336902557
Email
Hamidarazi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Guilan
Full name of responsible person
Abbas jafari
Position
PhD Student of Exercise Physiology
Latest degree
Master
Other areas of specialty/work
Exercise Physiology
Street address
University of Guilan, Postal Code 4199613776, Khalij Fars highway (5th km of Ghazvin road).
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13336902557
Email
abbast_jafari@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...