The purpose of this study is to improve the lives of women suffering from physical and mental pain after breast cancer
Design
Thirty female volunteers are randomly divided into two groups of 15 control and experimental.
Settings and conduct
Yoga exercises are applied to women who refer to the Breast Cancer Research Center of Motahhari Clinic in Shiraz by simple randomization and are under special care.
Participants/Inclusion and exclusion criteria
Entry requirements for participants:Women released from breast cancer;
Women over 25 years old;Women under 65 years old; Completion of radiotherapy and chemotherapy; Primary hypertension; No cognitive impairment by AMT tool; No history of depression or anxiety disorder based on patient statement or medical record; Do not use sedatives; No drug addiction.
Conditions for non-entry of participants:Women with acute heart disease;
Women who have chronic depression and are taking medication; Lack of cooperation or death of an elderly person; Do not attend more than 3 sessions.
Intervention groups
Experimental group on which yoga exercises were applied.
Control group on which no training is performed.
Main outcome variables
The most important consequences of this research:
1. Change in the way of looking at life by living happily
1. Reducing stress and anxiety
3. Increasing inner peace
2. Increasing muscle mass and bone density
3. Flexibility of joints and muscles
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200824048501N1
Registration date:2020-09-07, 1399/06/17
Registration timing:registered_while_recruiting
Last update:2020-09-07, 1399/06/17
Update count:0
Registration date
2020-09-07, 1399/06/17
Registrant information
Name
Tahereh Kohan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3624 3179
Email address
tarakohan1395@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-05, 1399/06/15
Expected recruitment end date
2020-11-05, 1399/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Relationship between physical activity, physical and motor function in patients with breast cancer: with interventional approach to yoga exercises
Public title
The effect of physical activity on women released from breast cancer
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Women with breast cancer
Women over 25 years old
Completion of radiotherapy and chemotherapy
Exclusion criteria:
Women with acute heart disease.
Women who have completed chemotherapy in less than two weeks.
Age
From 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Thirty female volunteers are randomly divided into two groups of fifteen control and experimental.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Marvdasht Azad University
Street address
Persepolis Boulevard, 3 km of Marvdasht
City
Marvdasht
Province
Fars
Postal code
73711-13119
Approval date
2020-06-13, 1399/03/24
Ethics committee reference number
IR.IAU.M.REC.1399.018
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
D70.1
ICD-10 code description
Agranulocytosis secondary to cancer chemotherapy
Primary outcomes
1
Description
Motor readiness
Timepoint
One month
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Improve physical condition
Timepoint
Physical condition is measured before the intervention begins. And it is done again two months after the yoga exercises.
Method of measurement
How to measure is done using physical fitness factors such as flexibility-balance.
Intervention groups
1
Description
Intervention group:Yoga exercises
Category
Lifestyle
2
Description
Control group: Inactivity
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahari Clinic, Shiraz
Full name of responsible person
Sadigheh Tahmasebi
Street address
Faghihi Hospital, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846316
Phone
+98 71 3235 1087
Email
tahmasebi.kh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sadigheh Tahmasebi
Street address
Faghihi Hospital, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
7134846316
Phone
+98 71 3235 1089
Email
tahmasebi.kh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The financial source is 100% the responsibility of the researcher.
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Nasibeh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Rolex Building, In front of the neighborhood park, Ali Rezaei, Mahallati, Ghodsi Gharbi, Shiraz
City
shiraz
Province
Fars
Postal code
7184855434
Phone
+98 71 3631 1755
Email
nasibe.kazemi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Nasibeh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Unit ,8 First floor, Opposite Neighborhood Park , Rolex Building, Ali Rezaei, Mahallati, Ghodsi Gharbi St, Shiraz
City
Shiraz
Province
Fars
Postal code
7184855434
Phone
+98 71 3631 1755
Email
nasibe.kazemi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahereh
Position
Sports Instructor (Yoga)
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Unit 1, First Floor, Kohan Building, Bustan Alley, Alley 36, Mirzai Shirazi Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
7196718377
Phone
+98 71 3624 3179
Email
tarakohan1395@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after unidentified individuals.
When the data will become available and for how long
6 months after the publication of the research results, the data can be accessed.
To whom data/document is available
It will be available to researchers at academic and scientific institutions.
Under which criteria data/document could be used
Will be available to assist researchers working in the field.
From where data/document is obtainable
Applicants can refer to Shiraz University of Medical Sciences, Zand St., central building.Email info@sums.ac.ir
What processes are involved for a request to access data/document
Researchers should refer to Shiraz University of Medical Sciences to access the data and request that it be reviewed by the University Council and provided to them at their discretion.