Protocol summary
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Study aim
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Investigation of low-volume high- intensity interval training, high- volume high- intensity interval training and continuous intensity moderate training on endothelial function of type 2 diabetes and relation with mechanisms involved in endothelial function.
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Design
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In this study, 70 participants divided into 4 groups low-volume high- intensity interval training, high- volume high- intensity interval training, continuous intensity moderate training and control. Randomization was performed by block randomization with a block size of 4.
Randomised clinical trial with single-blind and parallel groups.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Including criteria: included having a history of type 2 diabetes more than two years, glycosylated hemoglobin <6% (HbA1C <6%), body mass index over 25, hypertension uncontrolled pre or I stage, no history of 6 months of regular exercise (more than one day a week) to do the study.
Exclusion criteria included fasting blood glucose over 400 mg/dl, functional limitations (such as osteoarthritis), liver or kidney failure, history of myocardial infarction or coronary artery bypass surgery or angioplasty, chronic heart failure, cardiac arrhythmias, smoking, insulin therapy and HbA1C > 10%.
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Intervention groups
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1. High- volume high- intensity interval training that program was including 6 intervals 4 minutes at 85-90% HRmax that separated by 3 minutes active period at 45- 50% HRmax.
2. Low- volume high- intensity interval training that program was including 12 intervals 1.5 minutes at 85-90% HRmax that separated by 2 minutes active period at 55- 60% HRmax.
3. Continues moderate intensity training consist of 42 minutes at 70% HRmax.
4. Control group that maintenance daily activities and no have regular exercise.
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Main outcome variables
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Flow-mediated dilation; Diameter at baseline; Diameter at peak; Antegrade shear rate؛ Retrograde shear rate؛ Oscillatory shear index؛ Nitrite/ Nitrate; Endothelin-1; Apelin; Arterial stiffness; Superoxide dismutase; Malondialdehyde; Carotid intima-media thickness; Resistance insulin; Lipid profile; VO2peak; exercise time; Resting and maximal heart rate; Resting diastolic blood pressure; Resting systolic blood pressure
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT2015100423002N2
Registration date:
2016-03-04, 1394/12/14
Registration timing:
registered_while_recruiting
Last update:
2018-02-06, 1396/11/17
Update count:
1
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Registration date
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2016-03-04, 1394/12/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Investigator
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Expected recruitment start date
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2015-03-20, 1393/12/29
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Expected recruitment end date
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2016-03-20, 1395/01/01
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Actual recruitment start date
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2015-05-05, 1394/02/15
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Actual recruitment end date
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2016-04-24, 1395/02/05
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Trial completion date
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empty
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Scientific title
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Effect of differential exercise training on endothelial function of type 2 diabetes and relation with inflammatory cytokines
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Public title
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Effect of exercise training on endothelial function of type 2 diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
History of type 2 diabetes more than 2 years
No history of 6 months of regular exercise
Glycosylated hemoglobin <6%(HbA1C <6%)
Body mass index over 25
Hypertension uncontrolled pre or I stage
Exclusion criteria:
HbA1c over 10%
Fasting blood glucose more than 400 mg/dl
Functional limitations (such as osteoarthritis)
Liver and kidney disease
Myocardial infarction
Coronary artery bypass surgery or angioplasty
Chronic heart failure
Cardiac arrhythmia's
Smoking
Uncontrolled BP (BP < 170/100 mmHg)
Insulin therapy
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Age
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From 40 years old to 70 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
70
Actual sample size reached:
70
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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 4 assign participants to a block.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-07-31, 1395/05/10
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Ethics committee reference number
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IR.UT.Rec.1395002
Health conditions studied
1
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Description of health condition studied
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type 2diabetes
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ICD-10 code
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E 11
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ICD-10 code description
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Non-insulin-dependent diabetes mellitus
Primary outcomes
1
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Description
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Nitrite/Nitrate plasma
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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ELISA kit
2
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Description
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Endothelin-1
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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ELISA kit
3
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Description
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Flow mediated dilation
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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Ultrasound doppler
4
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Description
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Carotid intima-media thickness
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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Ultrasound doppler
5
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Description
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Insulin resistance
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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HOMA-IR
6
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Description
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Glucose
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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Enzymatic
7
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Description
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Applin
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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ELISA kit
8
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Description
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peak consumption oxygen
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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Gas analyser system
9
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Description
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Diastolic and systolic blood pressure
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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oscillometric device
10
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Description
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Heart rate rest
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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Cornometer/ numbere
11
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Description
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Lipid profile
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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Enzymatic
12
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Description
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Malondealdehid
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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ELISA kit
13
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Description
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Glutathion proxidase
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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ELISA kit
14
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Description
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Insulin
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Timepoint
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Before and after 12 week intervention
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Method of measurement
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ELISA kit
Intervention groups
1
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Description
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Intervention group 1: High- volume high- intensity interval training that consists of 6 intervals 4 minutes at 85- 90% HRmax which separated by 3 minutes at 45-50% HRmax.
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Category
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Rehabilitation
2
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Description
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Intervention group 2: High- volume high- intensity interval training that consists of 12 intervals 1.5 minutes at 85- 90% HRmax which separated by 2 minutes at 55-60% HRmax.
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Category
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Rehabilitation
3
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Description
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Intervention group3: continuous moderate intensity training consists of 42 minutes at 70% HRmax.
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Category
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Rehabilitation
4
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Description
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Control group: normal condition without any exercise
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice president of of Research of Tehran University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available