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Investigating the effect of acute exercise on cardiac autonomic nervous system indicators (HR and HRV) and correlation with the efficiency of the cardiopulmonary system in boys with type 1 diabetes at rest, during the GXT test, and during the exercise recovery period.

Protocol summary

Study aim
This clinical study aims to investigate the effect of an acute exercise session on cardiac autonomic performance indicators (HR, HRV parameters). Also, the relationship between cardiac autonomic performance indicators and cardiac and respiratory efficiency of boys with type 1 diabetes at rest, during the implementation of the standard increasing exercise program on the treadmill (GXT) and recovery is investigated.
Design
In this clinical study, 60 adolescent boys with T1D were grouped with metabolic markers of fasting blood sugar (FBS > 126 mg/dL) and HbA1c > 6.5%. the control group of 12 people healthy
Settings and conduct
All participants (diabetic and healthy) performed a standard acute exercise test to measure cardiac and respiratory functional capacity. The general results of VO2peak were compared with the parameters of HRV and HR 5 minutes, in resting conditions, GXT exercise test. Measurements were taken twice with an interval of two weeks.
Participants/Inclusion and exclusion criteria
Adolescents with T1D with metabolic markers FBG (> 126 mg/dL) and HBa1c (> 6.5%), average insulin injection 57 + 69, with a minimum history of 5 years, sedentary (> 5000). steps per day), the average daily calorie intake is 2432 ± 368.78 kcal per day, the average age is 15.32 ± 1.49 years (range 12-18) and the body mass index (19.68 ± 2), which is in tanner stages 3 to 5 were. Subjects were excluded from the study if they had any metabolic, mental, cardio-pulmonary, neurological and muscular disorders and if they used drugs that affected physical performance.
Intervention groups
60 adolescent boys with type 1 diabetes. Acute exercise sessions on a treadmill to investigate autonomic performance indicators.
Main outcome variables
HRV and HR during acute exercise HRV and HR at rest HRV and HR in recovery conditions Measuring the practical capacity of the cardiorespiratory system

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211031052926N2
Registration date: 2024-04-17, 1403/01/29
Registration timing: prospective

Last update: 2024-04-17, 1403/01/29
Update count: 0
Registration date
2024-04-17, 1403/01/29
Registrant information
Name
hossein saki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3349 3468
Email address
hossein.saki1990@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-20, 1403/02/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acute exercise on cardiac autonomic nervous system indicators (HR and HRV) and correlation with the efficiency of the cardiopulmonary system in boys with type 1 diabetes at rest, during the GXT test, and during the exercise recovery period.
Public title
The effect of acute exercise on cardiac autonomic nervous system (HR and HRV) of people with diabetes and presentation of regression model
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Boys with type 1 diabetes Absence of disease and use of special medicine
Exclusion criteria:
Symptoms of diabetic neuropathy, cerebrovascular or eye diseases and respiratory failure Taking certain medications other than insulin Taking drugs that affect resting heart rate Have regular exercise during the week
Age
From 12 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee of Hamedan University of Medical Sciences
Street address
Hamedan, Shahid Ahmadi Roshan Blvd., Faculty of Physical Education and Sports Sciences, Bo Ali Sina University.
City
Hamedan
Province
Hamadan
Postal code
6517493659
Approval date
2024-01-27, 1402/11/07
Ethics committee reference number
IR.UMSHA.REC.1402.670

Health conditions studied

1

Description of health condition studied
Boys with type 1 diabetes in Hamadan province
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus

Primary outcomes

1

Description
HR: heart rate
Timepoint
Rest, during increased exercise and post-exercise recovery period
Method of measurement
R-R and HR intervals of each subject's electrocardiogram using a heart rate monitor (18630, Medset GmbH, Hamburg, Germany) with a sampling frequency of 1000 Hz from the ECG signal with an accuracy of 1 millisecond for each interval, for 5 minutes in a quiet and comfortable room between It was recorded from 9 to 12 in the morning in a supine position.After recording R-R intervals, HR and resting blood pressure measurements, HRVexe and HRexe, and cardiorespiratory capacity (VO2peak ml/kg/min) using Bruce modified incremental exercise test (GXT) and gas analyzer in the test room. Exercise was performed at the Farshchian Cardiology Hospital under the supervision of a cardiologist.

2

Description
mR-R: Mean time between normal r waves
Timepoint
Rest, during increased exercise and post-exercise recovery period
Method of measurement
R-R and HR intervals of each subject's electrocardiogram using a heart rate monitor (18630, Medset GmbH, Hamburg, Germany) with a sampling frequency of 1000 Hz from the ECG signal with an accuracy of 1 millisecond for each interval, for 5 minutes in a quiet and comfortable room between It was recorded from 9 to 12 in the morning in a supine position.After recording R-R intervals, HR and resting blood pressure measurements, HRVexe and HRexe, and cardiorespiratory capacity (VO2peak ml/kg/min) using Bruce modified incremental exercise test (GXT) and gas analyzer in the test room. Exercise was performed at the Farshchian Cardiology Hospital under the supervision of a cardiologist.

3

Description
SDNN: Standard Deviation of all Normal RR intervals
Timepoint
Rest, during increased exercise and post-exercise recovery period
Method of measurement
R-R and HR intervals of each subject's electrocardiogram using a heart rate monitor (18630, Medset GmbH, Hamburg, Germany) with a sampling frequency of 1000 Hz from the ECG signal with an accuracy of 1 millisecond for each interval, for 5 minutes in a quiet and comfortable room between It was recorded from 9 to 12 in the morning in a supine position.After recording R-R intervals, HR and resting blood pressure measurements, HRVexe and HRexe, and cardiorespiratory capacity (VO2peak ml/kg/min) using Bruce modified incremental exercise test (GXT) and gas analyzer in the test room. Exercise was performed at the Farshchian Cardiology Hospital under the supervision of a cardiologist.

4

Description
rMSSD: root Means Square of Successive Differences in normal RR intervals
Timepoint
Rest, during increased exercise and post-exercise recovery period
Method of measurement
R-R and HR intervals of each subject's electrocardiogram using a heart rate monitor (18630, Medset GmbH, Hamburg, Germany) with a sampling frequency of 1000 Hz from the ECG signal with an accuracy of 1 millisecond for each interval, for 5 minutes in a quiet and comfortable room between It was recorded from 9 to 12 in the morning in a supine position.After recording R-R intervals, HR and resting blood pressure measurements, HRVexe and HRexe, and cardiorespiratory capacity (VO2peak ml/kg/min) using Bruce modified incremental exercise test (GXT) and gas analyzer in the test room. Exercise was performed at the Farshchian Cardiology Hospital under the supervision of a cardiologist.

5

Description
pNN50% : The percentage of the number of consecutive normal R-R intervals with an interval difference greater than 50 milliseconds divided by the number of normal R-R intervals
Timepoint
Rest, during increased exercise and post-exercise recovery period
Method of measurement
R-R and HR intervals of each subject's electrocardiogram using a heart rate monitor (18630, Medset GmbH, Hamburg, Germany) with a sampling frequency of 1000 Hz from the ECG signal with an accuracy of 1 millisecond for each interval, for 5 minutes in a quiet and comfortable room between It was recorded from 9 to 12 in the morning in a supine position.After recording R-R intervals, HR and resting blood pressure measurements, HRVexe and HRexe, and cardiorespiratory capacity (VO2peak ml/kg/min) using Bruce modified incremental exercise test (GXT) and gas analyzer in the test room. Exercise was performed at the Farshchian Cardiology Hospital under the supervision of a cardiologist.

6

Description
VLF: In the very low frequency band (0.0033–0.04 Hz), the intrinsic nervous system of the heart contributes to the VLF rhythm, and the SNS affects the amplitude and frequency of its oscillations.
Timepoint
Rest, during increased exercise and post-exercise recovery period
Method of measurement
R-R and HR intervals of each subject's electrocardiogram using a heart rate monitor (18630, Medset GmbH, Hamburg, Germany) with a sampling frequency of 1000 Hz from the ECG signal with an accuracy of 1 millisecond for each interval, for 5 minutes in a quiet and comfortable room between It was recorded from 9 to 12 in the morning in a supine position.After recording R-R intervals, HR and resting blood pressure measurements, HRVexe and HRexe, and cardiorespiratory capacity (VO2peak ml/kg/min) using Bruce modified incremental exercise test (GXT) and gas analyzer in the test room. Exercise was performed at the Farshchian Cardiology Hospital under the supervision of a cardiologist.

7

Description
LF: Low-Frequency power
Timepoint
Rest, during increased exercise and post-exercise recovery period
Method of measurement
R-R and HR intervals of each subject's electrocardiogram using a heart rate monitor (18630, Medset GmbH, Hamburg, Germany) with a sampling frequency of 1000 Hz from the ECG signal with an accuracy of 1 millisecond for each interval, for 5 minutes in a quiet and comfortable room between It was recorded from 9 to 12 in the morning in a supine position.After recording R-R intervals, HR and resting blood pressure measurements, HRVexe and HRexe, and cardiorespiratory capacity (VO2peak ml/kg/min) using Bruce modified incremental exercise test (GXT) and gas analyzer in the test room. Exercise was performed at the Farshchian Cardiology Hospital under the supervision of a cardiologist.

8

Description
HF: High-Frequency power
Timepoint
Rest, during increased exercise and post-exercise recovery period
Method of measurement
R-R and HR intervals of each subject's electrocardiogram using a heart rate monitor (18630, Medset GmbH, Hamburg, Germany) with a sampling frequency of 1000 Hz from the ECG signal with an accuracy of 1 millisecond for each interval, for 5 minutes in a quiet and comfortable room between It was recorded from 9 to 12 in the morning in a supine position.After recording R-R intervals, HR and resting blood pressure measurements, HRVexe and HRexe, and cardiorespiratory capacity (VO2peak ml/kg/min) using Bruce modified incremental exercise test (GXT) and gas analyzer in the test room. Exercise was performed at the Farshchian Cardiology Hospital under the supervision of a cardiologist.

9

Description
LF: HF: Ratio of low to high frequency power
Timepoint
Rest, during increased exercise and post-exercise recovery period
Method of measurement
R-R and HR intervals of each subject's electrocardiogram using a heart rate monitor (18630, Medset GmbH, Hamburg, Germany) with a sampling frequency of 1000 Hz from the ECG signal with an accuracy of 1 millisecond for each interval, for 5 minutes in a quiet and comfortable room between It was recorded from 9 to 12 in the morning in a supine position.After recording R-R intervals, HR and resting blood pressure measurements, HRVexe and HRexe, and cardiorespiratory capacity (VO2peak ml/kg/min) using Bruce modified incremental exercise test (GXT) and gas analyzer in the test room. Exercise was performed at the Farshchian Cardiology Hospital under the supervision of a cardiologist.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1. HRV and resting HR (HRVrest and HRrest): The person is placed in a lying position on the medical bed, and then the average heart rate in the last 5 minutes of ten minutes of rest is recorded.Each subject continues and completes the incremental protocol of Bruce on the treadmill (Graded Exercise Test: GXT) up to the threshold of 85% of his theoretical heart rate.2. HRV and HR of GXT exercise (HRVexe and HRexe): This parameter is determined in the last 5 minutes of Bruce's standard treadmill test with reliable tools.3. HRV and HR recovery (HRVrec and HRrec): In this situation, immediately after the end of standard GXT exercise, the person rests and lies down for 5 minutes, and then this parameter is measured with reliable tools.
Category
Diagnosis

2

Description
Control group: Adolescents with type 1 diabetes who did not have intense or regular sports activity.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Heart and Vascular Hospital, Hamedan
Full name of responsible person
Farnaz Fariba
Street address
Shahid Ahmadi Roshan Blvd, Bu Ali Sina University, Faculty of Physical Education
City
Hamedan
Province
Hamadan
Postal code
6593137396
Phone
+98 81 3827 3236
Email
hossein.saki1990@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farzad Nazem
Street address
Shahid Ahmadi Roshan Blvd, Hamadan University of Medical Sciences, Farshchian Hospital
City
Hamedan
Province
Hamadan
Postal code
6593137396
Phone
+98 81 3827 3236
Email
f.nazem@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Farnaz Fariba
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shahid Ahmadi Roshan Blvd, Hamadan University of Medical Sciences, Farshchian Hospital
City
Hamedan
Province
Hamadan
Postal code
6593137396
Phone
+98 81 3827 3236
Email
hossein.saki1990@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farnaz Fariba
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Shahid Ahmadi Roshan Blvd, Hamadan University of Medical Sciences, Farshchian Hospital
City
Hamedan
Province
Hamadan
Postal code
6593137396
Phone
+98 81 3827 3236
Email
hossein.saki1990@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farnaz Fariba
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Farshchian Hospital, Shahid Ahmadi Roshan Blvd, University of Medical Sciences, Hamedan
City
Hamedan
Province
Hamadan
Postal code
6593137396
Phone
+98 81 3827 3236
Email
hossein.saki1990@yahoo.com

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
Yes - There is a plan to make this available
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
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the data analysis of this research project, study protocol, statistical analysis, informed consent, and study report are presented in the final article. Microdata can be sent upon request.
When the data will become available and for how long
After the end of the research project
To whom data/document is available
It will be sent upon official request
Under which criteria data/document could be used
If diagnosed, help type 1 diabetes patients
From where data/document is obtainable
Corresponding Author
What processes are involved for a request to access data/document
The written request to the Corresponding Author of the project
Comments
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