Effect of a period of combined exercise training on tumor markers, blood glucose homeostasis, blood lipid, upper limb range of motion and quality of life among patients with diabetes type II after breast cancer surgery
Effect of a period of combined exercise training on tumor markers, blood glucose homeostasis and quality of life in patients with diabetes type 2 after breast cancer surgery among
Design
Randomized clinical trial with control group, non blinded, with parallel groups
Settings and conduct
Among type 2 diabetic patients after breast cancer surgery, thirty volunteer women will be selected as the study population and will randomly be divided into two experimental and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women with type 2 diabetes after breast cancer surgery, Performing Chemotherapy and Radiation Therapy
Exclusion criteria: Have any particular diet, and physical and mental problems that limit their participation in the training for example cardiovascular disease and cognitive disorders
Intervention groups
Experimental group: Combined exercises including aerobic training (at 50 to 75% of maximum heart rate) and resistance exercise (using elastic Bands) in each session, three sessions per week for 8 weeks.
Control group: Without intervention
Main outcome variables
Cancer markers, blood glucose homeostasis, blood lipids, upper limb range of motion, shoulder pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150531022498N29
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
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
2018-04-09, 1397/01/20
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a period of combined exercise training on tumor markers, blood glucose homeostasis, blood lipid, upper limb range of motion and quality of life among patients with diabetes type II after breast cancer surgery
Public title
Effect of a period of combined exercise training in patients with diabetes type II after breast cancer surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Women with type 2 diabetes after breast cancer surgery
Performing Chemotherapy and Radiation Therapy
Not having exercise training
Exclusion criteria:
Having any particular diet
Patients with psychiatric and nervous disorders who are being treated with sedative medicines
Patients with orthopedic, verbal and auditory problems
Age
From 46 years old to 67 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
Subjects were divided into 2 groups (one control group and 1 experimental groups) using the random numbers table
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 Rasht Azad University
Street address
Rasht Branchو Islamic Azad University, Taleshan Bridge
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.IAU.RASHT.REC.1396.157
2
Ethics committee
Name of ethics committee
Ethics committee of Rasht Azad University
Street address
Rasht Branch, Islamic Azad University, Taleshan Bridge
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.IAU.RASHT.REC.1396.156
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
CEA Plasma level
Timepoint
Before and after the end of 8weeks of training
Method of measurement
ELISA Kit
2
Description
CA15-3 Plasma level
Timepoint
Before and after the end of 8weeks of training
Method of measurement
ELISA Kit
3
Description
Fasting blood glucose
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
ELISA Kit
4
Description
Insulin resistance
Timepoint
Before and after the end of 8weeks of training
Method of measurement
ELISA Kit and HOMA-IR index
5
Description
Insulin
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
ELISA Kit
6
Description
shoulder pain
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using the MPQ Pain Questionnaire
7
Description
Range of motion of upper limb
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
goniometer
8
Description
Blood glucose
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
ELISA Kit
9
Description
Total Cholesterol
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
ELISA Kit
10
Description
Triglycerides
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
ELISA Kit
11
Description
High density lipoprotein
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
ELISA Kit
12
Description
low density lipoprotein
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
ELISA Kit
13
Description
HbA1c
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
ELISA Kit
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using the WHOQOL questionnaire
2
Description
Anxiety
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using the anxiety questionnaire
3
Description
physical fitness
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using aerobic power measurement
4
Description
Body composition
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Measure waist circumference , height , weight, body fat percentage, body mass index using the In body device.
Intervention groups
1
Description
Intervention group: Eight weeks of concurrent resistance and aerobic exercises with 3 sessions per week will be done. Aerobic exercise including Ergometer, treadmills and aerobic with an intensity of 50 to 75% of maximum heart rate will be conducted. Resistance exercises are done using elastic Bands.
Category
Rehabilitation
2
Description
Control group: Without any intervention, subjects in this group will continue their normal routines during the 8-week study period.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Gilan Radiotion oncology clinic
Full name of responsible person
Dr Hamid Saeidi Saedi
Street address
Shahid Ansari َAvenu, Namaz Blvd, Golsar
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Phone
+98 13 3375 9662
Email
maryamkoulaei@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht Branch, Islamic Azad University
Full name of responsible person
Ali Delpasand
Street address
Rasht Branch, Islamic Azad University, Taleshan Bridge
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?
Yes
Title of funding source
Rasht Branch, 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
Rasht Branch, Islamic Azad University
Full name of responsible person
Maryam kolaei, Pouran Akbari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Rasht Branch, Islamic Azad University, Taleshan Bridge
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
Pouranakb@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Azad University of Rasht Branch
Full name of responsible person
Dr. Ramin Shabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
ی 4147654919
Phone
+98 13 3342 2153
Email
shabani_msn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Azad University of Rasht Branch
Full name of responsible person
Marzieh Nazari
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Rasht Branch, Islamic Azad University, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
marzieh.nazari.v@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