The purpose of this research is evaluating the influence of pilates exercises on physical fitness and cardiovascular indices in breast cancer patients.
Participants of the study will include 30 female breast cancer patients who will participate in the study voluntarily and will be divided to two groups of exercise(n=15) and control(n=15) randomly. Exercise group will perform pilatese exercise for 8 weeks, 3 days a week for duration of 60 min in every session and control group will not participate in any regular physical activity. Exercise and control groups participate in study tests before and after experiment period which included Wells, alternate hand wall toss, one leg –stance, back and hand-grip dynamo-meter , sit up test (for measuring flexibility, coordination, back and hand strength and muscular strength respectively) . Resting heart rate and blood pressure will be measured using blood pressure monitor device and rate pressure product will be calculated using resting heart rate multiply by systolic blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016110113107N3
Registration date:2017-01-08, 1395/10/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-08, 1395/10/19
Registrant information
Name
Maryam Koushkie Jahrimi
Name of organization / entity
Shiraz University
Country
Iran (Islamic Republic of)
Phone
+98 71 1613 4666
Email address
mkoushki@rose.shirazu.ac.ir
Recruitment status
Recruitment complete
Funding source
self - Funded
Expected recruitment start date
2015-12-31, 1394/10/10
Expected recruitment end date
2016-12-31, 1395/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of 8 weeks pilates training on physical fitness and cardiorespiratory indices in breast cancer patients
Public title
Influence of exercise on breast cancer outcomes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:Having a period of chemotherapy and surgery, but at least one year before the study; being able to do exercise activity; Not having cardiovascular disease; not having any problem which limit exercise participation . Exclusion criteria: not regular participation in exercise activity; every physical problem which may interfere exercise activity
Age
From 30 years old to 44 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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study is performed on two groups of control and exercise
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shiraz University of Medical Sciences
Street address
Namazi Sq., Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.SUMS.REC.1395.114
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50.9
ICD-10 code description
Breast, unspecified
Primary outcomes
1
Description
Flexibility
Timepoint
Before and after exercise training
Method of measurement
Wells test
2
Description
Blood pressure and heart rate
Timepoint
Before and after exercise training
Method of measurement
Manometer
3
Description
Coordination
Timepoint
Before and after exercise training
Method of measurement
Tennis ball repeated throwing
4
Description
Balance
Timepoint
Before and after exercise training
Method of measurement
One leg stance
5
Description
Back extensor strength
Timepoint
Before and after exercise training
Method of measurement
Dynamometer
Secondary outcomes
1
Description
Muscle endurance
Timepoint
Befor and after exercise
Method of measurement
Sit and rich test
2
Description
Hand strength
Timepoint
Befor and after exercise
Method of measurement
Handgrip dynamometer
Intervention groups
1
Description
Control group will not take part in any kind of exercise activity and have their usual daily activity
Category
Placebo
2
Description
Intervention group: will perform Pilates exercise for 8 weeks, 3 days a week for duration of 60 min in every session. Pilates is performed with average intensity so that heart rate increase is very small and include flexibility and resistance exercises.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahhary clinical center
Full name of responsible person
Street address
namazi sq., zandst.
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
research deputy of Shiraz University
Full name of responsible person
Dr Ahmad Oryan
Street address
Shiraz University
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
research deputy of Shiraz University
Proportion provided by this source
100
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
Shiraz University
Full name of responsible person
Maryam Koushkie Jahromi
Position
PhD/Faculty
Other areas of specialty/work
Street address
Eram Sq., School of Education and Psychology
City
Shiraz
Postal code
Phone
+98 71 3613 4666
Fax
+98 917 702 3979
Email
koushkie53@yahoo.com
Web page address
www.shirazu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University
Full name of responsible person
maryam Koushkie Jahromi
Position
PhD
Other areas of specialty/work
Street address
Eram Sq., School of Education and Psychology
City
Shiraz
Postal code
Phone
+98 71 3613 4666
Fax
Email
koushkie53@yahoo.com
Web page address
www.shirazu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University
Full name of responsible person
maryam koushkie jahromi
Position
PhD
Other areas of specialty/work
Street address
Eram Sq., School of Education and Psychology
City
Shiraz
Postal code
Phone
00
Fax
Email
koushkie53@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)