Effect of 6 weeks of spinning and stationary bicycle training on serum levels of Asprosin and PBF in overweight and obese women.
Design
Clinical trial with control group (n = 15), with parallel groups [spinning exercise group (n = 15), Bike training group (n = 15)], Single blind, randomised trial
Settings and conduct
This is a clinical trial. This study will be a single blind study. The population of the study is obese and overweight women in the city. 60 members of the sports clubs are selected. They were randomly assigned to the (20 spinning training), (20 bicycle training), and (20 control group) groups.
Participants/Inclusion and exclusion criteria
Participants included obese and overweight women. The study involved 45 eligible people. They will be randomly assigned to the spinning exercise group (n = 15), the bike training group (n = 15) and the control group (n = 15).
Inclusion criteria:
General physical and mental health, Body mass index (BMI) More than 25 kg / m2, Not having regular exercise for 6 months before starting training
Participation in exercise activities, disease during exercise, pregnancy during exercise, and non-participation in each of the test groups
Exclusion criteria:
Participate in regular sports activities, Disease during exercise, Pregnancy during exercise, Refusing to continue cooperation
Intervention groups
spinning exercise group (n = 15), Bike training group (n = 15) and the control group (n = 15).
Main outcome variables
Asprosin, Fat percentage (kg/m 2)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029322N2
Registration date:2020-04-17, 1399/01/29
Registration timing:registered_while_recruiting
Last update:2020-04-17, 1399/01/29
Update count:0
Registration date
2020-04-17, 1399/01/29
Registrant information
Name
Hossein Nakhei
Name of organization / entity
University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 1374
Email address
h.nakhaei@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of 6 weeks of spinning and stationary bicycle trainings on serum levels of َAsprosin and PBF in overweight and obese women.
Public title
The effect of exercise on the Asprosin hormone in overweight and obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 25-40 years
General physical and mental health
Body mass index (BMI) more than 25 kg / m 2
Not having regular exercise for 6 months before starting training
Not having diseases: cardiovascular, diabetes, hormonal disorders, kidney and liver diseases, surgery, tobacco use and any medical intervention
Exclusion criteria:
Participate in regular sports activities
Disease during exercise
Pregnancy during exercise
Refusing to continue cooperation
Age
From 25 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block
Blinding (investigator's opinion)
Single blinded
Blinding description
Blood samples are collected. It is coded on the samples. Samples are taken to the laboratory for hormone measurement.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
university/regional research Ethics committee Zahedan University of medical sciences
Street address
Main campus, Zahedan, Sistan and Baluchestan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2020-02-02, 1398/11/13
Ethics committee reference number
IR.ZAUMS.REC.1398.445
Health conditions studied
1
Description of health condition studied
Obesity and overweight
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
Heart rate
Timepoint
Six weeks, One sessions a week
Method of measurement
Heartbeat watch
2
Description
Maximum oxygen consumption
Timepoint
Six weeks, One sessions a week
Method of measurement
Treadmill
Secondary outcomes
1
Description
Asprosin
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Asprosin Kit (ELISA ng/ml)
2
Description
Fat percentage (kg/m 2)
Timepoint
Before the intervention and two months after the intervention
Method of measurement
Related formula BF% = (0.41563 * X) - (0.00112 * 2) X + (0.03663 * Y) +4.03653
Intervention groups
1
Description
Intervention group: Spinning bicycle training, Training will be done by Spinning bicycle, It will take six weeks (three day a week, one hour each session).
Category
Rehabilitation
2
Description
Intervention group: Stationary bicycle training, Training will be done by Stationary bicycle, It will take six weeks (three day a week, one hour each session).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan University of Medical Sciences
Full name of responsible person
Hossein Nakhaei
Street address
Main campus, Dr. Hesabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
hossiennakhaie@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Seyed Mohammad Hashemi Shahri
Street address
Main campus, Dr. Hessabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Email
hossiennakhaie@yahoo.com
Web page address
http://zaums.ac.ir/default.page
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Hossein Nakhaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Main campus, Dr. Hassabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
hossiennakhaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hossein Nakhaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Main campus, Dr. Hessabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
hossiennakhaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hossein Nakhaei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Main campus, Dr. Hessabi Square
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5765
Email
hossiennakhaie@yahoo.com
Web page address
http://en.zaums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data including: (IPD), study protocol, statistical analysis map, informed consent form, clinical study report and data dictionary will be published upon completion of the study. This data will be published in a valid journal article format.
When the data will become available and for how long
Data will be available immediately upon completion of the project. It will probably be released in 1400.
To whom data/document is available
For researchers of academic and scientific institutions
Under which criteria data/document could be used
For the development of related sciences
From where data/document is obtainable
Refer to Zahedan University of Medical Sciences by letter
What processes are involved for a request to access data/document