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Response and Adaptation of the Cardiac Autonomic System to Functional High-Intensity Interval Training with Respiratory Face Masks: Impacts of Training Period and Face Mask Modality During Covid-19 Pandemic in Healthy Men

Protocol summary

Study aim
Increasing health and prevention
Design
Exercise program: including high-intensity interval training for 2 and 4 weeks with an intensity of 80 to 90% of maximum heart rate, three sessions per week, three times in each session in three groups, interval training (6 subjects), interval training + surgical mask (6 subjects) , exercise Interval + N95 mask (6 subjects) was done. Heart rate variability indices were evaluated before and after the training period.
Settings and conduct
The project in the sports clinic of the University of Mazandaran used a treadmill with a 12-lead electrocardiogram, a body composition device, a pulse oximeter and scales, exercises and sports tests with and without masks performed from 8 am to 2 pm.
Participants/Inclusion and exclusion criteria
Inclusion criteria:20-40 years old, with no history of chronic illness, including; arthritis, diabetes, high blood pressure, cancer, heart attack, chronic cough and bronchitis, no orthopedic injury, and no smoking history. Exit criteria: have Spo2 less than 95%, have at least one sign/symptom of fever or acute respiratory illness, history of travel to another country/state within 14 days before experience and close contact with confirmed COVID-19 patient by RT-PCR test.
Intervention groups
surgical and N95 mask, high-intensity interval training
Main outcome variables
Increase cardiac autonomic function by decreasing sympathetic activity and increasing parasympathetic heart rate variability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100205003281N2
Registration date: 2022-07-17, 1401/04/26
Registration timing: retrospective

Last update: 2022-07-17, 1401/04/26
Update count: 0
Registration date
2022-07-17, 1401/04/26
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
01125263818
Email address
v.dabidi@umz.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-08-20, 1399/05/30
Actual recruitment start date
2020-08-22, 1399/06/01
Actual recruitment end date
2020-09-20, 1399/06/30
Trial completion date
2020-11-15, 1399/08/25
Scientific title
Response and Adaptation of the Cardiac Autonomic System to Functional High-Intensity Interval Training with Respiratory Face Masks: Impacts of Training Period and Face Mask Modality During Covid-19 Pandemic in Healthy Men
Public title
"Effect of Exercise Training and Face Mask on the Cardiac Autonomic System"
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Those who do not have a History of Arthritis Those who do not have a History of Diabetes Those who do not have a History of High Blood Pressure Those who do not have a History of Cancer Those who do not have a History of Heart Attack Those who do not have a History of Chronic Cough and Bronchitis Those who do not have Orthopedic Injuries Those who have no History of Smoking
Exclusion criteria:
Have SpO2 Less than 95% Have at Least one Sign/Symptom of Fever or Acute Respiratory Disease Presence of Clinical Signs that any other Disease cannot explain Including; Systolic Blood Pressure Less than 90 mm Hg; Diastolic Blood Pressure greater than 95 mm Hg History of Travel to another Country/State within 14 Days before Experience and Close Contact with Confirmed COVID-19 Patient by RT-PCR Test
Age
From 20 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Actual sample size reached: 18
Randomization (investigator's opinion)
Randomized
Randomization description
First, a number was assigned to each of the participants. Then, the numbers were placed inside the era sphere, and each name removed was placed in the following groups: Interval training, N95 mask interval training, and Surgical mask interval training
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
Ethics Committee of University of Mazandaran
Street address
Pasdaran Ave, University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
4741613534
Approval date
2021-02-13, 1399/11/25
Ethics committee reference number
IR.UMZ.REC.1399.011

Health conditions studied

1

Description of health condition studied
Cardiac Autonomic System of Healthy Men
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
heart rate variability time-domain changing
Timepoint
Before the intervention, 14 and 28 days after high-intensity interval training with a mask and without a mask
Method of measurement
Cubius software

2

Description
heart rate variability frequency-domain changing
Timepoint
Before the intervention, 14 and 28 days after high-intensity interval training with a mask and without a mask
Method of measurement
Cubius software

3

Description
heart rate variability nonlinear-domain changing
Timepoint
Before the intervention, 14 and 28 days after high-intensity interval training with a mask and without a mask
Method of measurement
Cubius software

4

Description
Body composition changing
Timepoint
Before the intervention, 14 and 28 days after high-intensity interval training with a mask and without a mask
Method of measurement
body composition device

5

Description
SPO2 changing
Timepoint
Before the intervention, 14 and 28 days after high-intensity interval training with a mask and without a mask
Method of measurement
pulse oximeter

6

Description
Body weight changing
Timepoint
Before the intervention, 14 and 28 days after high-intensity interval training with a mask and without a mask
Method of measurement
scales

7

Description
Blood pressure changing
Timepoint
Before the intervention, 14 and 28 days after high-intensity interval training with a mask and without a mask
Method of measurement
Blood pressure monitor

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: high-intensity interval training group including air squats, push-ups, lunges, high knee, jumping lunges, butterfly, jump squats, seated leg circles, and back extension exercises with a surgical mask, for 2 to 4 weeks, three times a week, Three times per session
Category
Lifestyle

2

Description
Intervention group: high-intensity interval training group including air squats, push-ups, lunges, high knee, jumping lunges, butterfly, jump squats, seated leg circles, and back extension exercises with an N95 mask, for 2 to 4 weeks, three times a week, Three times per session
Category
Lifestyle

3

Description
Control group: high-intensity interval training group including air squats, push-ups, lunges, high knee, jumping lunges, butterfly, jump squats, seated leg circles, and back extension exercises with out mask, for 2 to 4 weeks, three times a week, Three times per session
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
University of Mazandaran Sports Clinic
Full name of responsible person
Valiollah, Dabidi Roshan
Street address
Pasdaran Street- University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
4741613534
Phone
+98 911 315 1509
Email
v.dabidi@umz.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Mazandaran
Full name of responsible person
Valiollah, Dabidi Roshan
Street address
Pasdaran Street- University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
4741613534
Phone
+98 911 315 1509
Email
v.dabidi@umz.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Mazandaran
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
University of Mazandaran
Full name of responsible person
Masomeh Fallah
Position
Ph.D degree Student
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
Pasdaran Street- University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
4741613534
Phone
+98 911 662 5054
Email
mfallah8365@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Mazandaran
Full name of responsible person
Valiollah Dabidi Roshan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Pasdaran Street- University of Mazandaran
City
babolsar
Province
Mazandaran
Postal code
4741613534
Phone
+98 911 315 1509
Email
v.dabidi@umz.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Mazandaran
Full name of responsible person
Masoumeh Fallah
Position
Ph.D degree Student
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
Pasdaran Street- University of Mazandaran
City
Babolsar
Province
Mazandaran
Postal code
4741613534
Phone
+98 911 662 5054
Email
mfallah8365@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Subjects' information is confidential.
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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The consent form is available
When the data will become available and for how long
Access period starts 8 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
After printing the results, the use of documents is allowed.
From where data/document is obtainable
Corresponding Author:Valiollah, Dabidi Roshan
What processes are involved for a request to access data/document
Two weeks after the request and pledge not to use the data
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