Protocol summary
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Study aim
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Effect of exercise training in different conditions (aerobic exercise in dry and water conditions) on heart rate variability
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Design
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A clinical trial with a control group based on the training environment with parallel training groups and a randomized, double-blinded design
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Settings and conduct
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The location of the study was conducted at the Sport Physiology Laboratory of Mohaghegh Ardebil University. In order to eliminate the bias caused by the subject's knowledge and evaluater, Heart Monitor Holter system results and the result of the study are conducted in a blind, two-way study. Given that the recorded frequencies of heart rate variability are transferred to the memory card of the Holter monitor card, it is normal that the subject and the assessing person do not know the type of effect of the intervention on the change in heart rate, and the subject is quite naturally just his practice according to the plan, and by recording the information device from his body, and at the stage of analysis, the researcher himself will have access to the recorded information.
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Participants/Inclusion and exclusion criteria
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The entry requirement is having age between 20 and 30 years old and having maximum oxygen intake between 48 and 55 ml per kg of body weight. The condition for leaving the study is injuries during training or symptoms of heart disease.
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Intervention groups
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Performing an aerobic exercise on a treadmill and aerobic exercise in a water environment with a temperature of 26 ° C and water at a temperature of 38 ° C and control group without exercise. Equivalent energy was applied to intervention groups.
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Main outcome variables
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Heart rate variability indexes include low frequency waves, high frequency waves, very low frequency waves, total power, percentage of sympathy system overcrowding and percentage of parasympathetic system overcome.
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:
IRCT20180724040579N1
Registration date:
2018-10-20, 1397/07/28
Registration timing:
retrospective
Last update:
2019-04-08, 1398/01/19
Update count:
1
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Registration date
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2018-10-20, 1397/07/28
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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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Expected recruitment start date
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2018-08-05, 1397/05/14
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Expected recruitment end date
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2018-09-04, 1397/06/13
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Actual recruitment start date
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2018-08-04, 1397/05/13
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Actual recruitment end date
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2018-09-04, 1397/06/13
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Trial completion date
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2018-09-04, 1397/06/13
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Scientific title
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The effect of exercise in different environmental conditions on the heart rate variability of healthy young men
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Public title
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heart rate variability of healthy young men
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Purpose
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Diagnostic
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having the maximum oxygen consumption in the range of 50-48 ml per kg of body weight per min
having no exercise plan outside the plan
not having any skin allergy to exercise in the aquatic environment
having a 20 to 30 year age
Exclusion criteria:
Seeing any cardiac failure in the diagnosis of a physician present in the research team during the test
Exit of the research due to irregular participation in training
any injuries during training
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Age
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From 20 years old to 30 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
165
Actual sample size reached:
165
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In order to randomize, simple randomization method with random number Table method was used . This table contains a bunch of numbers that are randomly drawn in the form of a table without a specific pattern and order. The numbers directions(Left, right, up, down) were first determined by the researcher to read the numbers and then the numbers were considered for different research groups. In the next step, the researcher randomly placed on one of the numbers and moved in the preset direction and recorded the numbers for that direction in the target group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In order to eliminate the bias caused by the subject's knowledge and evaluater, Heart Monitor Holter system results and the result of the study are conducted in a blind, two-way study. Given that the recorded frequencies of heart rate variability are transferred to the memory card of the Holter monitor card, it is normal that the subject and the assessing person do not know the type of effect of the intervention on the change in heart rate, and the subject is quite naturally just his practice according to the plan, and by recording the information device from his body, and at the stage of analysis, the researcher himself will have access to the recorded information.
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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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2018-02-04, 1396/11/15
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Ethics committee reference number
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IR.ARUMS.REC.1396.217
Health conditions studied
1
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Description of health condition studied
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Cardiovascular disease
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ICD-10 code
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I46.1
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ICD-10 code description
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Sudden cardiac death, so described
Primary outcomes
1
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Description
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cardiovascular response
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Timepoint
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After 20 consecutive workouts
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Method of measurement
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Use the My Patch & Vx3 + Monitor Holler
Secondary outcomes
1
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Description
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Sudden cardiac death prevention
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Timepoint
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20 dayes
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Method of measurement
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By Analyzing Heart Rate Variability Data
Intervention groups
1
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Description
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intervention group: exercise in Drought condition(treadmill)
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Category
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N/A
2
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Description
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Intervention group: exercise in warm water condition
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Category
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N/A
3
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Description
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Intervention group: exercise in normal water condition
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Category
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N/A
4
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Description
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Control group: no extra work
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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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Univercity of Mohageg Ardebili
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Proportion provided by this source
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50
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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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Share the results of a person's health
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When the data will become available and for how long
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1 month
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To whom data/document is available
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subjects
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Under which criteria data/document could be used
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In order to be aware of a healthy exercise environment
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From where data/document is obtainable
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University of Mohaghegh Ardabili, Department of Physical Education and Sport Sciences
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What processes are involved for a request to access data/document
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Apply to the Physical Education Department and receive data
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Comments
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