Protocol summary
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Study aim
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Examining the impact of eight weeks of selected aerobic and resistance training on myokin profile of patients improved from COVID-19
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Design
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Clinical trial has three groups of selected aerobic exercises, selected resistance exercises and control group
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Irisin؛ FGF21 and folistatin
General information
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Reason for update
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Change in sampling method
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Acronym
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IRCT registration information
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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
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Registration date
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2022-03-14, 1400/12/23
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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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2022-04-09, 1401/01/20
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Expected recruitment end date
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2022-04-16, 1401/01/27
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of eight weeks of selected aerobic and resistance training on myokine profile of patients improved from COVID-19
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Public title
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"The effect of aerobic and resistance training on patients improved from COVID-19"
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 45 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
33
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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).
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2022-02-06, 1400/11/17
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Ethics committee reference number
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IR.ABADANUMS.REC.1400.152
Health conditions studied
1
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Description of health condition studied
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COVID-19
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ICD-10 code
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U07.1
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ICD-10 code description
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COVID-19 disease
Primary outcomes
1
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Description
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Plasma levels of irisin
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Timepoint
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One day before the start of training protocols and forty-eight hours after the last training session
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Method of measurement
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Special irisin measurement kit
2
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Description
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Plasma levels of FGF21
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Timepoint
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One day before the start of training protocols and forty-eight hours after the last training session
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Method of measurement
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Special FGF21 measurement kit
3
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Description
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Plasma levels of folistatin
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Timepoint
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One day before the start of training protocols and forty-eight hours after the last training session
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Method of measurement
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Special follicatin measurement kit
Secondary outcomes
1
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Description
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Body mass index: It is a suitable measure for estimating the health of a person's weight according to height.
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Timepoint
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Before and after the intervention
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Method of measurement
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By calculating height and weight
2
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Description
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Maximum oxygen consumption: is the maximum amount of oxygen consumed by a person per kilogram of body weight in one minute.
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Timepoint
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Before and after the intervention
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Method of measurement
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Rockport Walk Test
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
2
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Description
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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.
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Category
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Rehabilitation
3
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Description
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Control group: does not receive any of these training interventions and their status will be followed up by phone and in person.
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Category
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Rehabilitation
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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Abadan University of Medical Sciences
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available