Protocol summary

Study aim
Comparison of the acute response of some inflammatory markers to circular resistance training in fasting in the morning and evening in obese men
Design
Clinical trial with cross over plan, Pragmatic, Randomised,
Settings and conduct
This study will be conducted to evaluate the comparison of the acute response of some inflammatory markers to circular resistance training in fasting in the morning and evening in obese men in the University sports complex in Sabzevar. Obese people will receive circular resistance training in the morning and in the evening with cross over plan. The response to treatment is evaluated using Luminescence quantitative and ELISA methods for the study groups.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Obese,age range, no taking the drug and tobacco, Lack of diabetes, heart and respiratory diseases, musculoskeletal, and metabolic disorders limiting exercise, Lack of high blood pressure, Lack of regular exercise activity in the last 6 months. Exclusion Criteria: Inability to perform exercises, Having regular sports activities rather than research exercises.
Intervention groups
Subjects will perform 6 movements: chest press, half squat stretch, front arm, armpit, back thigh and back opening in 4 sets with 12 max repetitions and 60% intensity of one max rep. Between each set of 1 minute and 2 minutes of rest each movement is considered. The Subjects in fasting condition (10 to 12 hours) will perform a resistance training session in the morning (8 AM) and after a 2-week rest, will perform the same resistance training session with the same conditions in the evening (5 PM).  In order to measure the biochemical variables, the blood sampling process is performed before, immediately and 2 hours after circular resistance training.
Main outcome variables
Determine the levels of CRP، TNF-α and IL-6

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191228045918N1
Registration date: 2020-02-15, 1398/11/26
Registration timing: retrospective

Last update: 2020-02-15, 1398/11/26
Update count: 0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Seyed Mehdi Beheshti Nasr
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 1378
Email address
beheshti.m1985@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-08-11, 1394/05/20
Actual recruitment start date
2015-04-21, 1394/02/01
Actual recruitment end date
2015-08-11, 1394/05/20
Trial completion date
2015-08-11, 1394/05/20
Scientific title
Comparison of the acute response of some inflammatory markers to circular resistance training in fasting in the morning and evening in obese men
Public title
Comparison of the acute response of inflammatory markers to circular resistance training in the morning and evening in obese men
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obese men Non-athlete No taking the drug and tobacco Lack of heart and respiratory diseases, Lack of diabetes Lack of musculoskeletal Age range between 20-30 years
Exclusion criteria:
Inability to perform exercises Having regular sports activities rather than research exercises
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Actual sample size reached: 15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Tohid Blvd, Sabzevar city
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Approval date
2014-01-15, 1392/10/25
Ethics committee reference number
MEDSAB.REC.1392.35

Health conditions studied

1

Description of health condition studied
Comparison of the acute response of some inflammatory markers to circular resistance training in the morning and evening
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Determine the levels of CRP
Timepoint
before, immediately and 2 hours after circular resistance training
Method of measurement
Use of Luminescence quantitative and ELISA methods

2

Description
Determine the levels of TNF-α
Timepoint
before, immediately and 2 hours after circular resistance training
Method of measurement
Use of Luminescence quantitative and ELISA methods

3

Description
Determine the levels of IL-6
Timepoint
before, immediately and 2 hours after circular resistance training
Method of measurement
Use of Luminescence quantitative and ELISA methods

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Subjects will perform 6 movements: chest press, half squat stretch, front arm, armpit, back thigh and back opening in 4 sets with 12 max repetitions and 60% intensity of one max rep. Between each set of 1 minute and 2 minutes of rest each movement is considered. The Subjects in fasting condition (10 to 12 hours) will perform a resistance training session in the morning (8 AM). In order to measure the biochemical variables, the blood sampling process is performed before, immediately and 2 hours after resistance exercise.
Category
Treatment - Other

2

Description
Intervention group: After a two-week rest, subjects in fasting condition (10 to 12 hours) will perform a resistance training session in the evening(5 PM), similar to the morning shift conditions. In order to measure the biochemical variables, the blood sampling process is performed before, immediately and 2 hours after resistance exercise.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
sports complex of Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Seyed Mehdi Beheshti Nasr
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
beheshti.m1985@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Dr. Fereshte Ghorat
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Email
Drghorat@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Seyed Mehdi Beheshti Nasr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
beheshti.m1985@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Seyed Mehdi Beheshti Nasr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
Beheshti.m1985@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Seyed Mehdi Beheshti Nasr
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Sabzevar University of Medical Sciences, Tohid Blvd., Sabzevar Town
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 1604
Email
Beheshti.m1985@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
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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