Protocol summary

Summary
The primary objective of this study was to evaluate the effect of a 6 week period of interval and continuous exercise on immune factors in breast cancer patients. Subjects consisted of 45 female patients with breast cancer between the ages of 40 to 49 years and are undergoing hormone therapy. Patients were randomly allocated to one of two exercise arm or control arm fall. Exercise training three days a week for 6 weeks is done. The control group do not exercise. At the beginning and end of the period, blood samples were taken to measure safety factors. Factors considered include changes in serum levels of total antioxidative capacity and malondialdehyde. Aerobic capacity is calculated with the formula.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016040327194N1
Registration date: 2016-05-06, 1395/02/17
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-05-06, 1395/02/17
Registrant information
Name
Samira Emadi Andani
Name of organization / entity
University of Shahrekord
Country
Iran (Islamic Republic of)
Phone
+98 913 475 9066
Email address
emadisamera1@gmail.com
Recruitment status
Recruitment complete
Funding source
Researcher and University of Shahrekord
Expected recruitment start date
2015-11-28, 1394/09/07
Expected recruitment end date
2016-01-10, 1394/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectof 6 Weeks of Low-volume High-Intensity Interval Training versus Moderate-Intensity Continuous Aerobic Exercise Training on Serum Malondialdehyde Level, Total Antioxidant Capacity and Aerobic Power in Breast Cancer Survivors
Public title
Cancer and Interval and Continuous Exercise Training
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Gender ( Female ), The participants are currently undergoing drug therapy(Tamoxifen); In the last 6 months have not participated in any regular exercise program; myocardial infarction, arrhythmias uncontrolled and extreme pressure (treated), do not have. Exclusion criteria: Absence of more than 2 sessions of 18 session; Recognition of the need to exclude health; personal desire to withdraw from the study; susceptibility to other diseases; accidents and the factors that cause the participants can participate in training sessions.
Age
From 40 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
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
University of Shahrekord
Street address
University of Shahrekord, Shahrekord
City
Shahrekord
Postal code
Group of Exercise ph
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
140/2735

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50.6
ICD-10 code description
Axillary tail of breast

Primary outcomes

1

Description
Malondialdehyde
Timepoint
Before and after 6 weeks exercise
Method of measurement
Using an ELISA kit

2

Description
Toal antioxidant capacity
Timepoint
Before and after 6 weeks exercise
Method of measurement
Using an ELISA kit

3

Description
Aerobic power
Timepoint
Before and after 6 weeks exercise
Method of measurement
Formula

Secondary outcomes

1

Description
Body fat percentage, Functional capacity
Timepoint
Before and after 6 weeks exercise
Method of measurement
Using calipers-formula Jackson, Test 6MWT

Intervention groups

1

Description
Six weeks interval exercise training for the experimental group
Category
Other

2

Description
Six weeks continuous exercise for the experimental group
Category
Other

3

Description
Use standard treatment control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospital Seyed Al Shohada
Full name of responsible person
Hemmati Simin
Street address
Group of oncology, Motahari street, Seyed Al Shohada Hospital, Esfahan
City
Esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Researcher
Full name of responsible person
Emadi Andani Samira
Street address
Esfahan
City
Esfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Researcher
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
University of Shahrekord
Full name of responsible person
Research deputy of University of Shahrekord
Street address
University of Shahrekord, Shahrekord
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Shahrekord
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Shahrekord
Full name of responsible person
Emadi Samira
Position
Master of Exercise Physiology
Other areas of specialty/work
Street address
University of Shahrekord, Shahrekord
City
Shahrekord
Postal code
003832324435
Phone
003832324435
Fax
Email
emadisamera1@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Shahrekord
Full name of responsible person
Azamian Jazee Akbar
Position
Associate Professor of Exercise Physiology
Other areas of specialty/work
Street address
Shahrekord, University of Shahrekord
City
Shahrekord
Postal code
Phone
+98 38323244017
Fax
Email
azamianakbar@yahoo.comazamian-a@lit.sku.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Shahrekord
Full name of responsible person
Emadi Samira
Position
Master of Exercise Physiology
Other areas of specialty/work
Street address
University of Shahrekord, Shahrekord
City
Shahrekord
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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