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The effect of a 10-week aerobic exercise on cardiac function among overweight female breast cancer survivors

Protocol summary

Study aim
evaluate the effect of an 10-week aerobic exercise on cardiac function among overweight female breast cancer survivors
Design
In this experimental study, the study population will be consisted of women with breast cancer admitted to Omid Hospital, Isfahan, Iran. Twenty five patients (age range: 30-55 years) wil randomly assign to one of the two groups of exercise (n= 15) and control (n= 10).samples wil be selected using sample size formula .
Settings and conduct
After evaluating body composition,cardiac function of the subjects and then aerobic exercise program will be performed with an intensity of (40-75) of maximal heart rate, and included warming up, main program is the coordination between arm and leg movements and the cooling. then number of block the time and intensity to reach the appropriate time will be added.
Participants/Inclusion and exclusion criteria
lack of regular physical activity,lack of smoking history,lack of other symptomatic diseases such as hypertension, overweight, history of surgery, chemotherapy and diagnosed at the same stage of the disease.
Intervention groups
In this study , the subjects will be divided into two groups of exercise and control. The control group was selected because of study is pre-test and post-test, and the requirement that that the effect of exercise on cardiac function in patients who did excersice and patients didn,t have any activity and we could compare it. The main intervention is a ten-weeks regular exercise program that it,s aime is observing the effect of exercise activity on improving cardiac function on overweight female breast cancer survivors
Main outcome variables
Exerciseimprove the cardiovascular and respiratory systems’ functions, strength, fatigue, depression and quality of life of the patient. with participating of Patients in the regular exercise can improve physiological, psychological and functional parameters.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190218042745N1
Registration date: 2019-04-15, 1398/01/26
Registration timing: retrospective

Last update: 2019-04-15, 1398/01/26
Update count: 0
Registration date
2019-04-15, 1398/01/26
Registrant information
Name
Mahnaz Sourani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4251 4183
Email address
m_sourani68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-05-30, 1396/03/09
Expected recruitment end date
2017-06-19, 1396/03/29
Actual recruitment start date
2017-06-09, 1396/03/19
Actual recruitment end date
2017-06-21, 1396/03/31
Trial completion date
2017-09-22, 1396/06/31
Scientific title
The effect of a 10-week aerobic exercise on cardiac function among overweight female breast cancer survivors
Public title
The effect of a 10-week aerobic exercise on cardiac function among overweight female breast cancer survivors
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
lack of regular physical activity during the past 6 months lack of smoking history, lack of other symptomatic diseases such as hypertension , diabetes, cardiopulmonary disease overweight history of surgery, chemotherapy diagnosed at the same stage of the disease
Exclusion criteria:
Age
From 30 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 25
Randomization (investigator's opinion)
Randomized
Randomization description
simple random
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 Isfahan univercity of medical sciences
Street address
Hezar Jerib Ave, Hsfahan Town
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-05-29, 1396/03/08
Ethics committee reference number
IR.MUI.REC.1396.2.082

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
c50-c50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
cardiac function
Timepoint
Before the intervention and at the end of the study
Method of measurement
Echocardiographic device

Secondary outcomes

empty

Intervention groups

1

Description
is a ten-weeks regular exercise program that it,s aime is observing the effect of exercise activity on improving cardiac function in abandoned breast cancer patients.The aerobic exercise training protocol was performed for 10 weeks with an intensity of 40 to 75% of maximal heart rate.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Seyed shohada hospital
Full name of responsible person
Mohammadreza Khosravi farsani
Street address
No, 10, 4 Alley, Farabi jonoobi Ave, Mardavij
City
اصفهان
Province
Isfehan
Postal code
8168976967
Phone
+98 31 3670 0804
Email
drmohammadkhf@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghaygh Haghjoo
Street address
Hezar Jerib Ave. Isfahan Town
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8032
Fax
+98 31 3668 2006
Email
jazb@mui.ac.ir
Web page address
https://mui.ac.ir
Grant name
specific program
Grant code / Reference number
1602001000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
30
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
Tehran Shahed Univercity
Full name of responsible person
Mahnaz Sourani
Position
Student
Latest degree
Master
Other areas of specialty/work
exercise physiology
Street address
NO,135, Alley Lale, Alley Mehr, Montazeri Shomali Ave, Najaf abad Town
City
Najaf abad
Province
Isfehan
Postal code
8514958369
Phone
+98 31 4251 4183
Email
m_sourani68@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammadreza Khosravi Farsani
Position
Assistant Professor Oncology and Hematology in Adults
Latest degree
Subspecialist
Other areas of specialty/work
Medical Oncology and Hematology in Adults
Street address
No, 10, 4 Alley, Farabi jonoobi Ave, Mardavij
City
Isfahan
Province
Isfehan
Postal code
8168976967
Phone
+98 31 3670 0804
Email
drmohammmadkhf@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
محمدرضا خسروی فارسانی
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
خون و سرطان بالغین
Street address
No, 10, 4 Alley, Farabi jonoobi Ave, Mardavij
City
Isfahan
Province
Isfehan
Postal code
8168976967
Phone
+98 31367000804
Email
drmohammmadkhf@gmail.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
because of this study is teamwork, we didin,t considered a plan for this study yet , and we need to gather the opinion of the group and then work on it.
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
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