Protocol summary

Study aim
Comparison of the effect of aerobic interval training, resistance training and combined training on glucose homeostasis, serum levels of preptin, osteocalcin and adiponectin in obese sedentary men
Design
Of the eligible population, 44 people voluntarily selected as samples and randomly divided into four groups of 11 (aerobic interval training; resistance training; aerobic interval training + resistance training; and Control).
Settings and conduct
The study was conducted as a public-call and announcement in the city of Mashhad for all individuals, and individuals contacted and have gotten information by the telephone number provided in the announcement for initial coordination (meeting time and get more information).
Participants/Inclusion and exclusion criteria
Obese men 1- Subjects are in the age range of 50-38 years. 2- The BMI of the subjects is between 35-30 kg / m2. 3. The percentage of body fat in the subjects is equal to and above 25%. 4- Subjects do not have regular exercise during the last 6 months.
Intervention groups
aerobic interval training; resistance training; aerobic interval training + resistance training; and Control
Main outcome variables
Fasting insulin, fasting glucose, insulin resistance, glycosylated hemoglobin, perpitin, osteocalcin, adiponectin, maximum oxygen intake, body mass index, body fat percentage, waist to hip ratio

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170102031720N3
Registration date: 2018-12-02, 1397/09/11
Registration timing: retrospective

Last update: 2018-12-02, 1397/09/11
Update count: 0
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3880 3000
Email address
rmohammadrahimi@mail.um.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
2018-10-07, 1397/07/15
Actual recruitment end date
2018-11-11, 1397/08/20
Trial completion date
2018-11-16, 1397/08/25
Scientific title
Comparison of the effect of aerobic interval training, resistance training and combined training on glucose homeostasis, preptin, osteocalcin and adiponectin in obese inactive men
Public title
Investigation of the effect of different exercises on glucose homeostasis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects do not have regular exercise during the past 6 months Body mass index is between 30-35 kg / m2
Exclusion criteria:
Having orthopedic problems People with heart failure
Age
From 38 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data and Safety Monitoring Board
Sample size
Target sample size: 44
Actual sample size reached: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, block
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, Outcome Assessment and DSMB are unaware of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ferdowsi University of Mashhad
Street address
Mashhad, Azadi Square, Paradise Daneshgah, Faculty of Sport Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Approval date
2018-09-22, 1397/06/31
Ethics committee reference number
IR.MUMS.REC.1397.203

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
Preptin, sample blood
Timepoint
Before and after intervention
Method of measurement
laboratory kit

2

Description
Osteocalcin, Blood sampling
Timepoint
Before and after intervention
Method of measurement
Laboratory kit

3

Description
Adiponectin, blood sampling
Timepoint
Before and after intervention
Method of measurement
laboratory kit

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: aerobic interval training; 3 session per week for 12 weeks(36 sessions) with intensity of 30-80% heart rate reserve
Category
Rehabilitation

2

Description
Intervention group 2: resistance training; 3 session per week for 12 weeks with 40-80% 1RM.
Category
Prevention

3

Description
Intervention group 3: aerobic interval training + resistance training; the training of two groups in the form of a meeting among
Category
Rehabilitation

4

Description
Control group: had no activity during the course of the study and were inactive (inactive lifestyle).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical Diagnostic Center
Full name of responsible person
Dr. Majid Sezavar
Street address
No 15, Aref 5, Aref St, Ahmadabad
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Phone
+98 51 3843 6558
Email
drsezavarlab@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Dr. Nahid Bizhe
Street address
Paradis Daneshgah, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Phone
+98 51 3880 5403
Email
bigeh@um.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ferdowsi University of Mashhad
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
Ferdowsi University of Mashhad
Full name of responsible person
Gholam Rasul Mohammad Rahimi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Paradis Daneshgah, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Phone
+98 51 3880 5403
Email
rmohammadrahimi@mail.um.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Gholam Rasul Mohammad Rahimi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Azadi Squer
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Phone
+98 51 3880 5403
Email
rmohammadrahimi@mail.um.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ferdowsi University of Mashhad
Full name of responsible person
Gholam Rasul Mohammad Rahimi
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Azadi Squre
City
Mashhad
Province
Razavi Khorasan
Postal code
9596116856
Phone
+98 51 3880 5403
Email
rmohammadrahimi@mail.um.ac.ir

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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
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
Not applicable
Data Dictionary
Not applicable
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