Protocol summary

Study aim
Evaluation of endocrine function and bone metabolism of inactive girls after physical activity
Design
A clinical trial with a control group, with parallel, randomized groups on 60 people will be performed for 4 weeks. A simple randomization method was used.
Settings and conduct
Participants will perform plyometric exercises with different intensities (low, medium and high) and low intensity+ blood flow restriction for 4 weeks (3 sessions per week) at Shahid Chamran University of Ahvaz. The training program consisted 10 minutes of warm-up, main training exercises and 10 minutes of cool down. The main training program consisted of four jump movements including deep jump (three sets of six repetitions), step jump (three sets of six repetitions), forward jump (two sets of eight repetitions) and side-to-side jump.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Being between 20 and 30 years old, having physical and mental health, having a low level of activity Exclusion criteria: Consumption of drugs, alcohol, smoking, osteopenia and osteoporosis , arthritis, diseases such as diabetes, thyroid, blood pressure, heart,
Intervention groups
1: High intensity training 2: Medium intensity 3: Low intensity 4: Low intensity + restriction of blood flow 5: Control
Main outcome variables
Undercarboxylated osteocalcin, Insulin, Glucose,

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181211041921N2
Registration date: 2020-11-07, 1399/08/17
Registration timing: retrospective

Last update: 2020-11-07, 1399/08/17
Update count: 0
Registration date
2020-11-07, 1399/08/17
Registrant information
Name
fatemeh fakhri
Name of organization / entity
Shahid Chamran University of Ahwaz
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 0019
Email address
fakhri.fatemeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-10, 1399/07/19
Expected recruitment end date
2020-10-30, 1399/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of traditional plyometric exercises with plyometric exercise with limited blood flow on the pancreatic- bone loop and biochemical markers of bone metabolism in inactive girls
Public title
The effect of plyometric exercises on endocrine function and bone metabolism indices
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being between 20 and 30 years old, having physical and mental health having a low level of activity
Exclusion criteria:
Consumption of drugs, alcohol, smoking, osteopenia and osteoporosis and its resulting bone fractures, arthritis, diseases such as diabetes, thyroid, blood pressure, heart, respiratory diseases and menstrual irregularities
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
...
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan
City
َAhvaz
Province
Khouzestan
Postal code
...
Approval date
2017-11-20, 1396/08/29
Ethics committee reference number
IR.AJUMS.REC.1396.617

Health conditions studied

1

Description of health condition studied
Endocrine function and metabolism
ICD-10 code
.
ICD-10 code description
.

Primary outcomes

1

Description
Under-carboxylated osteocalcin
Timepoint
Before and 48 hours after the 4-week intervention period
Method of measurement
Biochemical kits

2

Description
Insulin
Timepoint
Before and 48 hours after the 4-week intervention period
Method of measurement
Biochemical kits

3

Description
Glucose
Timepoint
Before and 48 hours after the 4-week intervention period
Method of measurement
Biochemical kits

Secondary outcomes

1

Description
Alkaline phosphatase
Timepoint
Before and 48 hours after the intervention
Method of measurement
Biochemical kit

2

Description
lipid profile
Timepoint
Before and 48 hours after the intervention period
Method of measurement
Biochemical kit

Intervention groups

1

Description
Intervention group 1: High intensity training- Participants will perform high intensity plyometric exercises for 4 weeks and 3 sessions per week in the gym of Shahid Chamran University.
Category
Prevention

2

Description
Intervention group 2: Medium intensity training- Participants will perform moderate intensity plyometric exercises for 4 weeks and 3 sessions per week in the gym of Shahid Chamran University.-
Category
Prevention

3

Description
Intervention group 3: Low intensity training.Participants will perform low intensity plyometric exercises for 4 weeks and 3 sessions per week in the gym of Shahid Chamran University.
Category
Prevention

4

Description
Intervention group 4: Low-intensity exercise with limited blood flow. A pneumatic air pressure cuff will be closed on the upper part of both subjects' legs during the exercise and the person will perform his exercises with low intensity.
Category
Prevention

5

Description
Control group: Control. Participants will not have any regular physical activity.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
ُShahid Chamran University of Ahvaz
Full name of responsible person
Dr. Akram Ahangarpour
Street address
Golestan Blvd
City
َAhvaz
Province
Khouzestan
Postal code
...
Phone
+98 61 3311 3820
Email
akramahangarpour@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Hajiye Shahbazyan
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
0000000000
Phone
+98 61 3311 2890
Email
diabets_center@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Prof. Akram Ahngarpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
...
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0613369539
Email
drc@ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Prof. Akram Ahngarpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
0098613369539
Email
drc@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
fatemeh fakhri
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Golestan Blvd.
City
Ahvaz
Province
Khouzestan
Postal code
6135783151
Phone
0-98613333320
Email
fakhri.fatemeh@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
....
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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