Comparison the effectiveness of a 6 months home-based aerobic High-intensity interval training (HIIT) and resistance exercises on glycemic and metabolic control of adolescents with type 1 diabetes mellitus and identification of disease related microRNAs
-To evaluate glycemic and metabolic control after 6 months home-based aerobic High-intensity interval training(HIIT) and resistance exercises in diabetic adolescents with Type 1Diabetes Mellitus in Isfahan
Design
Double-blind randomized controlled trial,with two arm parallel groups,phase 3 of 90 patients .Simple randomization with computer software
Settings and conduct
This study will be a double-blind randomized controlled trial, where equal numbers of participants will be assigned to either (i) High-intensity interval training (HIIT) group , (ii) Resistance exercise and (iii) control (CON) group. Participants in exercise intervention groups will complete two home-based resistance and high intensity aerobic exercise program for 26 weeks. The control group will be asked to maintain their current activity and dietary behaviors. Physiological and clinical measurements of cardiorespiratory fitness, body composition and cardiometabolic health will be done at baseline and on completion of the intervention at the 26th week.
Participants/Inclusion and exclusion criteria
Inclusion criteria; adolescents aged 14-18 years old with type 1 diabetes
Non inclusion criteria;Having movement restriction or movement disorder
Having limb or body injuries
Chronic cardiac or respiratory diseases, blood pressure
Any chronic disease that causes the child's inability to perform physical activity
Family history of sudden death, uncontrolled hypertension, type II diabetes and cardiovascular disease
Intervention groups
Control group
Intervention group1;High-intensity interval training
Intervention group 2; Resistance exercises
Comparison the effectiveness of a 6 months home-based aerobic High-intensity interval training (HIIT) and resistance exercises on glycemic and metabolic control of adolescents with type 1 diabetes mellitus and identification of disease related microRNAs
Public title
Comparisonthe effectiveness of a 6 months home-based aerobic High-intensity interval training and resistance exercises on glycemic of adolescents with type 1 diabetes mellitus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adolescents with Type 1 diabetes
14-18 years old
Exclusion criteria:
Having movement restriction or movement disorder
Having limb or body injuries
Chronic cardiac or respiratory diseases, blood pressure
Any chronic disease that causes the child's inability to perform physical activity
Family history of sudden death, uncontrolled hypertension, type II diabetes and cardiovascular disease
Age
From 14 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization,table of random number
In this study, first the subjects (90 people) are selected and a two-digit code is assigned to each of them, and the researcher randomly starts from a point of the table in the direction of the row or column to select the sample people from the table considering the last two digits of the numbers in the table as follows;the first 30 as the control group, the second 30 as the intervention group 1, and the third 30 as the intervention group 2.
Blinding (investigator's opinion)
Double blinded
Blinding description
The adolescents with Type 1 diabetes and the investigator who collect the data and assess the outcomes will be blinded
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-07-22, 1401/04/31
Ethics committee reference number
IR.MUI.MED.REC.1401.168
Health conditions studied
1
Description of health condition studied
Type1 diabetes mellitus
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Glycemic control
Timepoint
Measurement of Hemoglobin A1c at baseline and 6 months after exercises
Method of measurement
blood test
Secondary outcomes
1
Description
Metabolic control (lipid profile,fasting blood sugar)
Timepoint
At baseline and 6 month after intervention
Method of measurement
Blood test
Intervention groups
1
Description
Control group: High-intensity interval training(High intensity interval training (HIIT) is a mode of aerobic exercise training that consists of an activity phase and a rest phase. The activity phase includes some exercises that are performed with high intensity and speed, but the period of rest time is short, such as pedaling on a bicycle or any other exercise activity, and then a rest period is considered). The exercises of each session last for 60-90 minutes, for a period of 12 weeks and 3 sessions per week with direct or indirect supervision of researchers or exercise training specialists.
Category
Lifestyle
2
Description
Intervention group: Resistance exercises(The method of selected resistance exercises will include exercises using body weight or other simple equipment such as exercises with elastic bands). The exercises of each session last for 60-90 minutes, for a period of 12 weeks and 3 sessions per week with direct or indirect supervision of researchers or exercise training specialists.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossien Childrens Hospital
Full name of responsible person
Mahin Hashemipou
Street address
Imam Khomeini
City
Isfahan
Province
Isfehan
Postal code
81951-63381
Phone
+98 31 3386 1005
Email
hashemipour@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3061
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
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
100
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
Esfahan University of Medical Sciences
Full name of responsible person
Silva Hovsepian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Type 1 diabetes
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5257
Email
s.hovsepian@res.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Silva Hovsepian
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Type 1 diabetes
Street address
Hezar jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5257
Email
s.hovsepian@res.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Silva Hovsepian
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Type 1 diabetes
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5257
Email
s.hovsepian@res.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Not applicable
Title and more details about the data/document
Non-identifiable data of the participants and information about the investigated outcomes
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
Researchers from academic institutions working in the field of type 1 diabetes mellitus or physical activity
Under which criteria data/document could be used
deidentifiable data
Using data to design similar researches
Using by health system officials and workers to implement effective interventions at community level and for larger population
From where data/document is obtainable
The applicant can get their requested documents by contacting with the Principle Investigator
Silva Hovsepian
s.hovsepian@res.mui.ac.ir
What processes are involved for a request to access data/document
After receiving the email with the request to receive the documents, the PI will consult with the project colleagues and if possible, the data will be emailed within 2 weeks.