1. Home
  2. Approved trials
  3. » فارسی

Effect of concurrent resistance and aerobic training on salivary levels of pro-inflammatory and hormonal factors, sleep quality and quality of life in postmenopausal women with breast cancer

Protocol summary

Study aim
Determining the effect of concurrent training on salivary levels of IL-12, TNF-a, IL-12/ TNF-α, testosterone, cortisol, testosterone/ cortisol, sleep quality, quality of life and fitness in postmenopausal women with breast cancer
Design
Clinical trials with community based and pragmatic control group, with parallel groups, one blind, randomized
Settings and conduct
Exercises will be do at the Sports gym of the Physical Education Faculty of Razi University of Kermanshah
Participants/Inclusion and exclusion criteria
Have 30 to 70 years old. Have breast cancer. Survival from surgery and chemotherapy. Be Postmenopausal. Be at I,II stage of the disease. Have no inflammatory the gum and mouth disease.
Intervention groups
Groups include exercises and controls. The exercise group will perform the resistance training 2-3 sets 10-18 repetitions, with 50-70% 1RM and aerobic training with 50-70% maxHR and 12-14 degrees Borg scale, for 20-40 minutes for 8 weeks. The control group will be the same as their previous lifestyle.
Main outcome variables
Changes in Interleukin 12, TNF-a, Cortisol, Testosterone, Sleep Quality and Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181024041445N1
Registration date: 2019-01-24, 1397/11/04
Registration timing: retrospective

Last update: 2019-01-24, 1397/11/04
Update count: 0
Registration date
2019-01-24, 1397/11/04
Registrant information
Name
kheirollah yari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6473
Email address
kyari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-31, 1397/08/09
Expected recruitment end date
2018-11-14, 1397/08/23
Actual recruitment start date
2018-10-31, 1397/08/09
Actual recruitment end date
2018-12-24, 1397/10/03
Trial completion date
2019-03-11, 1397/12/20
Scientific title
Effect of concurrent resistance and aerobic training on salivary levels of pro-inflammatory and hormonal factors, sleep quality and quality of life in postmenopausal women with breast cancer
Public title
Effect of concurrent training on breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30 to 70 years old Have breast cancer Survival from surgery and chemotherapy Be postmenopausal Be at I,II stage of the disease Have no inflammatory the gum and mouth disease
Exclusion criteria:
Have metastasized Have other underlying disease Do not have the ability to do sports
Age
From 30 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 42
Actual sample size reached: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery
Blinding (investigator's opinion)
Single blinded
Blinding description
Subjects in control and exercise group
Placebo
Not used
Assignment
Parallel
Other design features
Measuring salivary levels of pro-inflammatory and hormonal agents

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Parastar
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.KUMS.1397.708

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
N60.09
ICD-10 code description
Solitary cyst of unspecified breast

Primary outcomes

1

Description
The effect of 8 weeks concurrent resistance and aerobic training on salivary levels of interleukin 12, TNF-a, cortisol, testosterone and quality of sleep and quality of life in postmenopausal women with breast cancer
Timepoint
Before and after 8 weeks of exercise
Method of measurement
Using ELISA kit and questionnaire and body composition analyzer

Secondary outcomes

1

Description
Changes in waist circumference, weight, body mass index, waist-hip ratio
Timepoint
Before and after 8 weeks of exercise
Method of measurement
Body composition analyzer

Intervention groups

1

Description
Intervention is exercise training that will performed, resistance training 3-2 sets of 10-18 repeated, with 70-50% of 1RM and aerobic exercise with 50-70% maxHR and 12-14 degrees Borg scale, 20-40 minutes to 8 weeks.
Category
Lifestyle

2

Description
Control group:The control group will continue to lose its previous lifestyle without exercise training.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital oncology ward of Imam Reza
Full name of responsible person
Mehrdad Payandeh
Street address
Parastar
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3426 2252
Email
royamomenpur@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Amir Abbas Monazzami
Street address
Parastar
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 2987
Email
monazzami.amirabbas@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
1
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
Department of Physical Education Razi University
Full name of responsible person
Amirabbas Monazzami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Bagh Abrisham
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9266
Email
monazzami.amirabbas@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Department of Physical Education Razi University
Full name of responsible person
Amirabbas Monazzami
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Bagh Abrisham
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9266
Email
monazzami.amirabbas@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Department of Physical Education Razi University
Full name of responsible person
Roya Moumenpour
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Bagh Abrisham
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9266
Email
royamomenpur@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
Main outcomes and meanings and final charts
When the data will become available and for how long
2019-2
To whom data/document is available
It will be accessible to the public
Under which criteria data/document could be used
Inferential statistics
From where data/document is obtainable
E-mail to royamomenpur@gmail.com
What processes are involved for a request to access data/document
Send mail
Comments
Loading...