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Protocol summary
Inclusion criteria: Improved women from COVID-19; Women between the ages of 20 and 45; Non-consumption of alcohol and tobacco; No other medical problems. Exclusion criteria: pregnancy, exercise during the past year and taking medication
Inclusion criteria: recovered individuals from COVID-19; Women between the ages of 20 and 45; Non-consumption of alcohol and tobacco; No other medical problems. Exclusion criteria: pregnancy, exercise during the past year and taking medication
Inclusion criteria: Improved womenrecovered individuals from COVID-19; Women between the ages of 20 and 45; Non-consumption of alcohol and tobacco; No other medical problems. Exclusion criteria: pregnancy, exercise during the past year and taking medication
شرایط ورود به مطالعه: زنان بهبود یافته از COVID-19؛ زنان با دامنه سنی 20 تا 45 سال ؛ عدم مصرف الکل و دخانیات؛ عدم ابتلا به مشکلات طبی دیگر. شرایط عدم ورود به مطالعه: بارداری، داشتن فعالیت ورزشی در طول یک سال گذشته و مصرف دارو
شرایط ورود به مطالعه: افراد بهبود یافته از COVID-19؛ زنان با دامنه سنی 20 تا 45 سال ؛ عدم مصرف الکل و دخانیات؛ عدم ابتلا به مشکلات طبی دیگر. شرایط عدم ورود به مطالعه: بارداری، داشتن فعالیت ورزشی در طول یک سال گذشته و مصرف دارو
شرایط ورود به مطالعه: زنانافراد بهبود یافته از COVID-19؛ زنان با دامنه سنی 20 تا 45 سال ؛ عدم مصرف الکل و دخانیات؛ عدم ابتلا به مشکلات طبی دیگر. شرایط عدم ورود به مطالعه: بارداری، داشتن فعالیت ورزشی در طول یک سال گذشته و مصرف دارو
General information
Improved women from COVID-19
Women in the age range of 20 to 45 years
No other medical problems including cardiovascular disease, chronic liver, kidney, gastrointestinal disease, immune deficiency, chronic inflammatory disease and metabolic diseases
Lack of muscle, joint and orthopedic problems that prevent exercise
People recovering from COVID-19
Women in the age range of 20 to 45 years
No other medical problems including cardiovascular disease, chronic liver, kidney, gastrointestinal disease, immune deficiency, chronic inflammatory disease and metabolic diseases
Lack of muscle, joint and orthopedic problems that prevent exercise
Improved womenPeople recovering from COVID-19 Women in the age range of 20 to 45 years No other medical problems including cardiovascular disease, chronic liver, kidney, gastrointestinal disease, immune deficiency, chronic inflammatory disease and metabolic diseases Lack of muscle, joint and orthopedic problems that prevent exercise
زنان بهبود یافته از COVID-19
زنان با دامنه سنی 20 تا 45 سال
عدم ابتلا به مشکلات طبی دیگر از جمله بیماریهای قلبی عروقی، بیماری مزمن کبدی، کلیوی، گوارشی، نقص سیستم ایمنی، بیماری التهابی مزمن و بیماریهای متابولیکی
عدم وجود مشکلات عضلانی، مفصلی و ارتوپدی که مانع از انجام فعالیت ورزشی شود
افراد بهبود یافته از COVID-19
زنان با دامنه سنی 20 تا 45 سال
عدم ابتلا به مشکلات طبی دیگر از جمله بیماریهای قلبی عروقی، بیماری مزمن کبدی، کلیوی، گوارشی، نقص سیستم ایمنی، بیماری التهابی مزمن و بیماریهای متابولیکی
عدم وجود مشکلات عضلانی، مفصلی و ارتوپدی که مانع از انجام فعالیت ورزشی شود
زنانافراد بهبود یافته از COVID-19 زنان با دامنه سنی 20 تا 45 سال عدم ابتلا به مشکلات طبی دیگر از جمله بیماریهای قلبی عروقی، بیماری مزمن کبدی، کلیوی، گوارشی، نقص سیستم ایمنی، بیماری التهابی مزمن و بیماریهای متابولیکی عدم وجود مشکلات عضلانی، مفصلی و ارتوپدی که مانع از انجام فعالیت ورزشی شود
Secondary outcomes
#1
Measure height and weight
By calculating height and weight
MeasureBy calculating height and weight
اندازه گیری قد و وزن
از طریق محاسبه قد و وزن
اندازه گیریاز طریق محاسبه قد و وزن
Recruitment centers
#1
Name of recruitment center - English: Improved patients from Kovid 19 of Abadan and Khorramshahr counties who announce their readiness by
Name of recruitment center - Persian: بیماران بهبود یافته از کووید 19 شهرستانهای آبادان و خرمشهر که از طریق فراخوان اعلام آمادگی می کنند.
Full name of responsible person - English: Parisa Amiri Farsani
Full name of responsible person - Persian: پریسا امیری فارسانی
Street address - English: Khorramshahr University of Marine Sciences and Technology
Street address - Persian: دانشگاه علوم و فنون دریایی خرمشهر
City - English: Abadan and Khorramshahr
City - Persian: آبادان و خرمشهر
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6316953111
Phone: +98 61 5353 1938
Fax:
Email: parisaamirif@yahoo.com
Web page address:
Name of recruitment center - English: Improved patients from Kovid 19 of Abadan and Khorramshahr counties who announce their readiness by
Name of recruitment center - Persian: بیماران بهبود یافته از کووید 19 شهرستانهای آبادان و خرمشهر که از طریق فراخوان اعلام آمادگی می کنند.
Full name of responsible person - English: Parisa Amiri Farsani
Full name of responsible person - Persian: پریسا امیری فارسانی
Street address - English: Khorramshahr University of Marine Sciences and Technology
Street address - Persian: دانشگاه علوم و فنون دریایی خرمشهر
City - English: Abadan and Khorramshahr
City - Persian: آبادان و خرمشهر
Province: Khouzestan
Country: Iran (Islamic Republic of)
Postal code: 6316953111
Phone: +98 61 5353 1938
Fax:
Email: parisaamirif@yahoo.com
Web page address:
Name of recruitment center - English: Improved patients from Kovid 19 of Abadan and Khorramshahr counties who announce their readiness by Name of recruitment center - Persian: بیماران بهبود یافته از کووید 19 شهرستانهای آبادان و خرمشهر که از طریق فراخوان اعلام آمادگی می کنند. Full name of responsible person - English: Parisa Amiri Farsani Full name of responsible person - Persian: پریسا امیری فارسانی Street address - English: Khorramshahr University of Marine Sciences and Technology Street address - Persian: دانشگاه علوم و فنون دریایی خرمشهر City - English: Abadan and Khorramshahr City - Persian: آبادان و خرمشهر Province: Khouzestan Country: Iran (Islamic Republic of) Postal code: 6316953111 Phone: +98 61 5353 1938 Fax: Email: parisaamirif@yahoo.com Web page address:
Protocol summary
Study aim
Examining the impact of eight weeks of selected aerobic and resistance training on myokin profile of patients improved from COVID-19
Design
Clinical trial has three groups of selected aerobic exercises, selected resistance exercises and control group
Settings and conduct
Among the improved female patients from Covid 19 who declare their readiness by recall, 33 people were selected based on inclusion criteria and voluntarily and in a simple random method in three groups of selected aerobic exercises, selected resistance training groups. And will be in the control group. The aerobic training group performed exercises with an intensity of 50 to 70% of the maximum oxygen consumption and the resistance training group performed exercises with an intensity of 40 to 75% of a maximum repetition, for 8 weeks and three sessions per week located in the gym of Islamic Azad University, Abadan Branch will run. In order to determine the levels of research variables, all subjects will be present in the laboratory between 8 am and 10 am the day before the start of the exercise program to take a blood sample. The training groups will then participate in the training protocol. 48 hours After the last training session, all subjects will participate in blood sampling in the same pre-test conditions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: recovered individuals from COVID-19; Women between the ages of 20 and 45; Non-consumption of alcohol and tobacco; No other medical problems. Exclusion criteria: pregnancy, exercise during the past year and taking medication
Intervention groups
Aerobic exercise group: Exercise with an intensity of 50 to 70% of maximum heart rate, Resistance exercise group: Exercise with an intensity of 40 to 75% of a maximum repetition and control group: None of these interventions receives exercise.
Main outcome variables
Irisin؛ FGF21 and folistatin
General information
Reason for update
Change in sampling method
Acronym
IRCT registration information
IRCT registration number:IRCT20220209053982N1
Registration date:2022-03-14, 1400/12/23
Registration timing:prospective
Last update:2022-07-02, 1401/04/11
Update count:2
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Parisa Amiri farsani
Name of organization / entity
Islamic Azad University, Abadan Branch
Country
Iran (Islamic Republic of)
Phone
+98 61 5353 1938
Email address
parisaamirif@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-09, 1401/01/20
Expected recruitment end date
2022-04-16, 1401/01/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of selected aerobic and resistance training on myokine profile of patients improved from COVID-19
Public title
"The effect of aerobic and resistance training on patients improved from COVID-19"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People recovering from COVID-19
Women in the age range of 20 to 45 years
No other medical problems including cardiovascular disease, chronic liver, kidney, gastrointestinal disease, immune deficiency, chronic inflammatory disease and metabolic diseases
Lack of muscle, joint and orthopedic problems that prevent exercise
Exclusion criteria:
Pregnancy
Having been active in sports for the past year
taking medication
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
33
Randomization (investigator's opinion)
Randomized
Randomization description
First, in Abadan and Khorramshahr counties, and then among the people who announce their readiness, 33 people are selected voluntarily based on the inclusion criteria and are randomly divided into three groups. In the simple random method, each person is assigned a number, then the folded sheets, which include the number of each person, are placed in a container, and based on the lottery, the above numbers are arranged in three groups of selected aerobic exercises (11 people). ), Selected resistance exercises (11 people) and the control group (11 people).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
First, the sample individuals are selected voluntarily based on the inclusion criteria and then randomly divided into three groups: aerobic training, resistance training and control.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Abadan University of Medical Sciences
Street address
The beginning of 30 meters of Zolfaghari
City
Abadan
Province
Khouzestan
Postal code
6319811154
Approval date
2022-02-06, 1400/11/17
Ethics committee reference number
IR.ABADANUMS.REC.1400.152
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19 disease
Primary outcomes
1
Description
Plasma levels of irisin
Timepoint
One day before the start of training protocols and forty-eight hours after the last training session
Method of measurement
Special irisin measurement kit
2
Description
Plasma levels of FGF21
Timepoint
One day before the start of training protocols and forty-eight hours after the last training session
Method of measurement
Special FGF21 measurement kit
3
Description
Plasma levels of folistatin
Timepoint
One day before the start of training protocols and forty-eight hours after the last training session
Method of measurement
Special follicatin measurement kit
Secondary outcomes
1
Description
Body mass index: It is a suitable measure for estimating the health of a person's weight according to height.
Timepoint
Before and after the intervention
Method of measurement
By calculating height and weight
2
Description
Maximum oxygen consumption: is the maximum amount of oxygen consumed by a person per kilogram of body weight in one minute.
Timepoint
Before and after the intervention
Method of measurement
Rockport Walk Test
Intervention groups
1
Description
Aerobic exercise group: Exercises including running with an intensity of 50 to 70% of maximum heart rate, three sessions per week for eight weeks located in the gym of the Islamic Azad University, Abadan Branch.
Category
Rehabilitation
2
Description
Resistance training group: Exercises including eight movements of chest press, squat, forearm, leg press, back arm, front thigh, boat and back with intensity of 40 to 75% of a maximum repetition, three sessions per week for eight weeks in the gym Islamic Azad University, Abadan Branch will be implemented.
Category
Rehabilitation
3
Description
Control group: does not receive any of these training interventions and their status will be followed up by phone and in person.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Improved patients from Kovid 19 of Abadan and Khorramshahr counties who announce their readiness by
Full name of responsible person
Parisa Amiri Farsani
Street address
Khorramshahr University of Marine Sciences and Technology
City
Abadan and Khorramshahr
Province
Khouzestan
Postal code
6316953111
Phone
+98 61 5353 1938
Email
parisaamirif@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abadan University of Medical Sciences
Full name of responsible person
Massoud Torabpour
Street address
The beginning of 30 meters of Zolfaghari
City
Abadan
Province
Khouzestan
Postal code
6319811154
Phone
+98 61 5238 4004
Email
info@abadanums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abadan 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
Islamic Azad University, Science and Research Branch of Tehran
Full name of responsible person
Parisa Amiri Farsani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
No. 16, Arghavan Alley, Professors' Alley, University of Marine Sciences and Technology, Ali Ibn Abitaleb Boulevard
City
Khorramshahr
Province
Khouzestan
Postal code
64199-34619
Phone
+98 61 5353 1938
Email
parisaamirif@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Science and Research Branch of Tehran
Full name of responsible person
Farshad Ghazalian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport physiology
Street address
Islamic Azad University, Science and Research Branch, Shohada Hesarak Blvd., University Square, End of Shahid Sattari Highway
City
Tehran
Province
Tehran
Postal code
1477893855
Phone
+98 21 44865154-8
Email
phdghazalian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Science and Research Branch of Tehran
Full name of responsible person
Parisa Amiri Farsani
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Sport physiology
Street address
No. 16, Arghavan Alley, Professors' Alley, University of Marine Sciences and Technology, Ali Ibn Abitaleb Boulevard
City
Khorramshahr
Province
Khouzestan
Postal code
64199-34619
Phone
+98 61 5353 1938
Email
parisaamirif@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available