The effect of concurrent aerobic-resistance training on T4 , TSH, blood lipids, leptin, cortisol, blood glucose homeostasis, and physical fitness in girls with hypothyroidism
The effect of concurrent aerobic-resistance training on T4 , TSH, blood lipids, leptin, cortisol, blood glucose homeostasis, and physical fitness in girls with hypothyroidism
Design
Randomized clinical trial with control group, non blinded, with parallel groups
Settings and conduct
The present research is a semi-experimental study on patients with with hypothyroid in 17 shahrivar Hospital in Rasht , after the introduction of Endocrinologist will participate in exercise training three days a week for 8 weeks. Aerobic training is at 60 to 70% of maximum heart rate) and resistance exercise using Bodybuilding machine with an intensity of 40 to 65% of 1RM. Blood sampling is performed before and after eight weeks of training.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Girls with hypothyroid Having age range 60 to 75 years Not having exercise training
Intervention groups
Experimental group: Combined exercises including aerobic training (at 60 to 70% of maximum heart rate) and resistance exercise (using Bodybuilding machine with an intensity of 40 to 65% of 1RM)
Control group: Without intervention
Main outcome variables
T4, FSH, blood glucose homeostasis, blood lipids
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150531022498N26
Registration date:2018-10-25, 1397/08/03
Registration timing:retrospective
Last update:2018-10-25, 1397/08/03
Update count:0
Registration date
2018-10-25, 1397/08/03
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
2016-04-19, 1395/01/31
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
2016-04-19, 1395/01/31
Actual recruitment end date
2016-06-20, 1395/03/31
Trial completion date
2016-06-20, 1395/03/31
Scientific title
The effect of concurrent aerobic-resistance training on T4 , TSH, blood lipids, leptin, cortisol, blood glucose homeostasis, and physical fitness in girls with hypothyroidism
Public title
The effect of concurrent aerobic-resistance training in girls with hypothyroidism
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Girls with hypothyroid
Having age range 60 to 75 years
Not having exercise training
Exclusion criteria:
Patients with psychiatric and nervous disorders who are being treated with sedative medicines
Patients with orthopedic, verbal and auditory problems
Age
From 8 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were divided into 2 groups (one control group and one experimental groups) using the simple random method. This sampling will be done based on the red and blue balls inside the box that are randomly taken by the subjects (Red Orb and the Blue Orb of the experimental group).
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
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2017-01-17, 1395/10/28
Ethics committee reference number
IR.IAU.RASHT.REC.1395.59
2
Ethics committee
Name of ethics committee
Ethics committee of Rasht Azad University
Street address
Islamic Azad University Rasht Branch, Taleshan Bridge, Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Approval date
2016-08-18, 1395/05/28
Ethics committee reference number
IR.IAU.RASHT.REC.1395.23
Health conditions studied
1
Description of health condition studied
Hypothyroidism
ICD-10 code
E03
ICD-10 code description
Other hypothyroidism
Primary outcomes
1
Description
TSH
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
2
Description
T4
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
3
Description
Leptin
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
4
Description
Cortisol
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
5
Description
Fasting Blood glucose
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
6
Description
Insulin
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
7
Description
low density lipoprotein
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
8
Description
High density lipoprotein
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
9
Description
Cholstrol
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
10
Description
Triglyceride
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using ELISA Kit
11
Description
HOMA
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using Insulin Resistance Formula
Secondary outcomes
1
Description
Rest Metabolism Rate
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using Mifflin formula
2
Description
Anaerobic power
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
using RAST test
3
Description
Aerobic power
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using shuttle run
4
Description
Power
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using Force Gauges
5
Description
Body composition
Timepoint
Before and after the end of 8 weeks of training
Method of measurement
Using by measurement of weight, body mass index (BMI), fat percent, fat free mass and waist circumference
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 aerobic running with an intensity of 60 to 70% of maximum heart rate will be conducted. Resistance exercises are done using Bodybuilding machine with an intensity of 40 to 65% of 1RM
Category
Prevention
2
Description
Control group: Without intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Children's Hospital
Full name of responsible person
Dr Setila Dalili
Street address
Opposite the City Park, Siadati Av., Namjo Ave., Rasht
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3336 9026
Email
shabani_msn@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
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?
No
Title of funding source
Rasht 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
Islamic Azad University
Full name of responsible person
Masomeh Amani
Position
Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
Rasht Branch, Islamic Azad University, Taleshan Bridge
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Email
amanisetare@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ramin shabani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
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
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marzieh Nazari
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Exercise physiology
Street address
Rasht Branch, Islamic Azad University, Taleshan Bridge
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