1. Home
  2. Approved trials
  3. » فارسی

Comparison of Continuous Moderate-Intensity Training and High-Intensity Interval Training on Vasodilators And Cardiac Function in Type 2 Diabetes

Protocol summary

Study aim
Comparison of continuous moderate-intensity training and high-intensity interval training on vasodilators and cardiac function in type 2 diabetes.
Design
In this study, 47 participants divided into 3 groups high- intensity interval training, continuous intensity moderate training and control. Randomization was performed by block randomization with a block size of 15. Randomised clinical trial with single-blind and parallel groups.
Settings and conduct
This Study Was Performed in Physical Education of University of Tehran and Metabolism and Diabetes Center of Shariati hospital. Participants, outcome assessor and statistic specialist was blinded. They did not know which group they were in because they were assigned in groups based on randomization and the codes they provided. The specialists of assessment and statistical analysis were unaware of the study because the groups were sent to him based on coding.
Participants/Inclusion and exclusion criteria
Entrance Criteria: Type 2 Diabetes According to Defined by American Diabetes Association fasting blood sugar (FBS) more than 7 mmol/L. Haemoglobin Glycosylated (HbA1c) above 6%. Pre- or stage I hypertension, or treated hypertension (systolic blood pressure 120–159 mmHg. Diastolic blood pressure 80–99 mmHg. No exercise training in the previous 6 months. Non-Entry Criteria: Patients with FBS more than 22 mmol/L. HbA1c above 10%. Functional limitations (such as osteoarthritis), liver or kidney Disease, and Smoking.
Intervention groups
Intervention Group 1: Continuous Moderate-Intensity Training on Stationary Bike Intervention Group 2: High-Intensity Interval Training on Stationary Bike Control Group: No Training
Main outcome variables
Adropin; Nitric Oxide; Resistance insulin; Fasting Glucose; VO2peak; Exercise Time; Resting and maximal heart rate; Resting diastolic blood pressure; Resting systolic blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181219042056N1
Registration date: 2019-05-13, 1398/02/23
Registration timing: retrospective

Last update: 2019-05-13, 1398/02/23
Update count: 0
Registration date
2019-05-13, 1398/02/23
Registrant information
Name
Ramin Salehi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 51 3621 1916
Email address
salehi.1371@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-02-24, 1396/12/05
Actual recruitment start date
2017-12-16, 1396/09/25
Actual recruitment end date
2018-06-26, 1397/04/05
Trial completion date
2018-12-16, 1397/09/25
Scientific title
Comparison of Continuous Moderate-Intensity Training and High-Intensity Interval Training on Vasodilators And Cardiac Function in Type 2 Diabetes
Public title
Comparison of Continuous Moderate-Intensity Training and High-Intensity Interval Training on Vasodilators And Cardiac Function in Type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45 to 60 years. According to Defined by American Diabetes Association 2015, fasting blood sugar (FBS) more than 7 mmol/L. Glycosylated Haemoglobin (HbA1c) above 6%. Type 2 Diabetes. Pre- or stage I hypertension, or treated hypertension (systolic blood pressure 120–159 mmHg, diastolic blood pressure 80–99 mmHg). Patients with history of Type 2 Diabetes for at least 2 years. No exercise training in the previous 6 months.
Exclusion criteria:
Patients with FBS more than 22 mmol/L. HbA1c above 10%. Myocardial infarction, coronary artery bypass surgery or angioplasty, chronic heart failure, cardiac arrhythmia, functional limitations (such as osteoarthritis), liver or kidney disease, and smoking. Hypertension, or treated hypertension (systolic blood pressure 170 mmHg, diastolic blood pressure 100 mmHg).
Age
From 45 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 47
Actual sample size reached: 47
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized to Intervention And Control Groups. Block randomization work by randomizing participants within blocks such that an equal number are assigned to each intervention groups. Given a block size in this study was 15 assign participants to a block.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were aware of the study. However, they did not know assigned to which groups, because they were assigned in groups based on randomization and the codes. The evaluators are specialists who were unaware of the grouping and the purpose of the study. Statistical analysis was performed by statisticians who were unaware of the study because the groups were sent to him based on coding.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Faculty of Physical Education and Sport Sciences - University of Tehran
Street address
Tehran Province, Tehran, North Kargar
City
Tehran
Province
Tehran
Postal code
14398-13117
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.UT.SPORT.REC.1397.010

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Adropin Factor
Timepoint
Before and After from 12 week exercise
Method of measurement
Using the Laboratory Elisa Kit

2

Description
Nitrite/Nitrate plasma
Timepoint
Before and After from 12 week exercise
Method of measurement
Using the Laboratory Elisa Kit

3

Description
HOMA-IR
Timepoint
Before and After from 12 week exercise
Method of measurement
HOMA-IR

4

Description
Glucose
Timepoint
Before and After from 12 week exercise
Method of measurement
Enzymatic

5

Description
peak consumption oxygen
Timepoint
Before and After from 12 week exercise
Method of measurement
Gas analyser system

6

Description
Diastolic and systolic blood pressure
Timepoint
Before and After from 12 week exercise
Method of measurement
oscillometric device

7

Description
Heart rate rest
Timepoint
Before and After from 12 week exercise
Method of measurement
Cornometer/ numbere

8

Description
Insulin
Timepoint
Before and After from 12 week exercise
Method of measurement
ELISA kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Doing 12 weeks continuous moderate-intensity training (70 % Heart Rate max) on cycle , every week 3 times and every time 1 hour pedal
Category
Rehabilitation

2

Description
Intervention group 2: Doing 12 weeks High-Intensity Interval Training (85-90% Heart Rate max) on cycle , every week 3 times and every time 1 hour pedal
Category
Rehabilitation

3

Description
Control group: normal condition without any exercise
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes and Metabolic Disease Institute of Shariati haspital
Full name of responsible person
Maryam pour abbas
Street address
Metabolism and Diabetes Center of Shariati hospital, North Kargar Street, Enghelab Square,Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1021
Email
shariatihosp@tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice president of of Research of Tehran University
Full name of responsible person
Dr Foad Seidi
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
14398-13117
Phone
+98 21 8835 1730
Email
infosport@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice president of of Research of Tehran University
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
Vice president of of Research of Tehran University
Full name of responsible person
Ramin Salehi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
14398-13117
Phone
+98 21 8835 1730
Email
salehi.1371@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Vice president of of Research of Tehran University
Full name of responsible person
Ramin Salehi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
14398-13117
Phone
+98 21 8835 1730
Email
salehi.1371@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Vice president of of Research of Tehran University
Full name of responsible person
Ramin Salehi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
North Kargar
City
Tehran
Province
Tehran
Postal code
14398-13117
Phone
+98 21 8835 1730
Email
salehi.1371@ut.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
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some of data
When the data will become available and for how long
1 year after publish
To whom data/document is available
All of people
Under which criteria data/document could be used
For scientific study
From where data/document is obtainable
Salehi.1371@ut.ac.ir
What processes are involved for a request to access data/document
In First Time After observetion in Email Adress
Comments
Loading...