The effect of combined yoga and pilates training on sexual hormones, leptin, cortisol, glucose homeostasis and tumor markers on breast cancer survivors
The effects of a combined yoga and pilates training in serums sex hormones, leptin, cortisol, glucose homeostasis and biomarkers in breast cancer survivors
Design
In this study, 30 breast cancer survivors will be voluntarily attended. Which are randomly divided into two groups of experimental group (n=15) and control group (n=15).
Settings and conduct
The present study is a randomized controlled trial on breast cancer survivors in Rasht city. Subjects will attend a combined yoga and pilates training program for 12 weeks. Measurement of some physiological factors and blood level of tumor markers and hormones before and after 12 weeks of circular training will be performed.
Participants/Inclusion and exclusion criteria
inclusion criteria: Ability to perform exercise training with oncologist approval, underwent partial mastectomy, termination of chemotherapy
exclusion criteria: More than three consecutive sessions or four intermittent sessions absence from the training injury during training
Intervention groups
Intervention group: 12 weeks of combined yoga and pilates training, three sessions per week, 75 minutes each session. Exercise training program consists of 10 minutes warming up, 30 minutes pilates training, 30 minutes yoga training and 5 minutes cooling down
Control group: 12 weeks. routine daily activities
Main outcome variables
sex hormones, leptin, cortisol, glucose homeostasis and biomarkers
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150531022498N34
Registration date:2020-06-27, 1399/04/07
Registration timing:prospective
Last update:2020-06-27, 1399/04/07
Update count:0
Registration date
2020-06-27, 1399/04/07
Registrant information
Name
Ramin Shabani
Name of organization / entity
Islamic Azad University
Country
Iran (Islamic Republic of)
Phone
+98 13 3375 2715
Email address
shabani@iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-29, 1399/04/09
Expected recruitment end date
2020-09-30, 1399/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of combined yoga and pilates training on sexual hormones, leptin, cortisol, glucose homeostasis and tumor markers on breast cancer survivors
Public title
Effect of combined training on breast cancer survivors
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to perform exercise training with oncologist approval
underwent partial mastectomy
termination of chemotherapy
age between 35-50
Exclusion criteria:
More than three consecutive sessions or four intermittent sessions absence from the training
injury during training
Age
From 35 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a randomized controlled trial that thirty breast cancer survivors were selected as participants in the research process. After the necessary investigations and based on the information of the completed questionnaires, the subjects were divided into two groups of 15 people using a lottery by simple random method.
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 Azad University, Lahijan Branch
Street address
Shaghayegh Street, East Kashef Street, Lahijan City
City
Lahijan
Province
Guilan
Postal code
4416939515
Approval date
2020-06-09, 1399/03/20
Ethics committee reference number
IR.IAU.LIAU.REC.1399.008
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis (MS)
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Fasting Blood Sugar
Timepoint
before and after the end of intervention
Method of measurement
Serum levels using Enzymatic method
2
Description
CA 15-3 tumor marker
Timepoint
before and after the end of intervention
Method of measurement
Serum levels using Eliza method
3
Description
CA 125 tumor marker
Timepoint
before and after the end of intervention
Method of measurement
Serum levels using Eliza method
4
Description
CEA tumor marker
Timepoint
before and after the end of intervention
Method of measurement
Serum levels using Eliza method
5
Description
Cortisol hormone
Timepoint
before and after the end of intervention
Method of measurement
Serum levels using Eliza method
6
Description
Estrogen Hormone
Timepoint
before and after the end of intervention
Method of measurement
Serum levels using Eliza method
7
Description
Testosterone Hormone
Timepoint
before and after the end of intervention
Method of measurement
Serum levels using Eliza method
8
Description
SHBG
Timepoint
before and after the end of intervention
Method of measurement
Serum levels using Eliza method
Secondary outcomes
1
Description
HbA1C
Timepoint
Before and after the end of interventions
Method of measurement
Serum levels using Enzymatic method
2
Description
Insulin hormone
Timepoint
Before and after the end of interventions
Method of measurement
Serum levels using Eliza method
3
Description
Leptin hormon
Timepoint
Before and after the end of interventions
Method of measurement
Serum levels using Eliza method
Intervention groups
1
Description
Intervention group: 12 weeks of combined yoga and pilates training, three sessions per week, 75 minutes each session. Exercise training program consists of 10 minutes warming up, 30 minutes pilates training, 30 minutes yoga training and 5 minutes cooling down
Category
Other
2
Description
Control group: 12 weeks. routine daily activities
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Guilan Oncology Centre
Full name of responsible person
Dr Hamid Saeidi
Street address
Golsar Street, Namaz Blv.
City
Rasht
Province
Guilan
Postal code
4163934774
Phone
+98 13 3376 3222
Email
hamidsaedi53@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ali Delpasand
Street address
Lakan St., Poltaleshan Blv. , Rasht, Gilan, Iran
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
shabani_msn@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
En Islamic Azad University
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samane Ebrahimpour
Position
PHD candidate
Latest degree
Master
Other areas of specialty/work
exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4153911900
Phone
+98 13 4466 5179
Email
s99.ebrahimpour@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Rasht Branch
Full name of responsible person
Ramin Shabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
Lakan St., Poltaleshan Blv. , Rasht, Gilan, Iran
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
shabani_msn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samane Ebrahimpour
Position
PHD candidate
Latest degree
Master
Other areas of specialty/work
exercise physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4153911900
Phone
+98 13 4466 5179
Email
s99.ebrahimpour@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available