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Effect of 6 Weeks of Low-Repetition and Light-Load Power Training on Serum Levels of b-ALP and CTX in Postmenopausal Women

Protocol summary

Study aim
Present study aims to survey effects of 6 weeks of low-repetition and light-load power training on serum Octeocalcin, Paratormone, Sclerostin, Bone Alkalin Phosphatase and C- terminal telopeptides of type I collagen in postmenopausal women.
Design
Clinical trial with control group, randomized, not blinded on 24 postmenopausal women. The table of random numbers will be used.
Settings and conduct
During menopause, reduced ovarian activity is associated with a drop in the level of hormones and its complications such as cardiovascular disease and osteoporosis. Present study are conducted in Zahedan city. 24 healthy and sedentary postmenopausal women will participate in this semi experimental study. They will be selected on purpose and will be randomly divided into two equal groups; experimental and control. Experimental group will perform 6 weeks low-repetition and light-load power training while control group wouldn't perform any activities.
Participants/Inclusion and exclusion criteria
Inclusion criteria were having no exercise background and no regular sport activity in past one year, at least two years should be passed from their menopause time, having no special problems such as cardiovascular, metabolic, kidney, orthopedic diseases and no smoking. The exclusion criteria include applying any medication, food supplements and diet therapy.
Intervention groups
The Training group which perform Low-Repetition and Light-Load Power Training and Control group don't participate in any physical exercises in intervention period.
Main outcome variables
Measurements of serum levels of Osteocalcin, Paratormone, Sclerostin, Bone Alkalin Phosphatase and C- terminal telopeptides of type I collagen.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043935N1
Registration date: 2020-05-23, 1399/03/03
Registration timing: retrospective

Last update: 2020-05-23, 1399/03/03
Update count: 0
Registration date
2020-05-23, 1399/03/03
Registrant information
Name
Shila Nayebifar
Name of organization / entity
The University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3223 8192
Email address
shila_nayebifar@ped.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2019-10-23, 1398/08/01
Trial completion date
2020-01-21, 1398/11/01
Scientific title
Effect of 6 Weeks of Low-Repetition and Light-Load Power Training on Serum Levels of b-ALP and CTX in Postmenopausal Women
Public title
Effect of Low-Repetition and Light-Load Power Training on Post menopausal Women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having no exercise background At least two years should be passed from their menopause time. Not having any special problems such as cardiovascular, metabolic, kidney, orthopedic diseases. No smoking.
Exclusion criteria:
The exclusion criteria include applying any medication and food supplements, diet therapy. Being in amenorrhea state
Age
From 55 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Actual sample size reached: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple Randomization, Randomization unit: individually, Randomization tool: Table of Random Numbers, How to make Randomization sequence: From the top to the end of list, Allocation Concealment: A third person allocate numbers to the participants then using table of Random Numbers another person select the numbers with closed eyes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sistan and Baluchestan University
Street address
Daneshgah Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816976153
Approval date
2019-10-22, 1398/07/30
Ethics committee reference number
Code number: IR.USB.REC.1398.002

Health conditions studied

1

Description of health condition studied
Menopause
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Osteoporosis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum levels of Osteocalcin.
Timepoint
At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session).
Method of measurement
Measurement of serum Osteocalcin will be assessed using a kit (Zell Bio, Germany) with a sensitivity of 0.026 ng/ml.

2

Description
Serum levels of Paratormone.
Timepoint
At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session).
Method of measurement
Paratormon will be assessed using a kit (Zell Bio, Germany) with a sensitivity of 1.56 ng/ml.

3

Description
Serum levels of Sclerostin.
Timepoint
At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session).
Method of measurement
Sclerostin will be assessed using Hangzhou Stabiopharm kit (China), with a sensitivity of 0.26 ng/ml and ELISA method.

4

Description
Serum levels of Bone Alkalin Phosphatase.
Timepoint
At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session).
Method of measurement
Bone Alkalin Phosphatase will be assessed using Hangzhou Stabiopharm kit (China), with a sensitivity of 0.52 pmol/l and ELISA method.

5

Description
Serum levels of C- terminal telopeptides of type I collagen.
Timepoint
At the beginning of program (before starting intervention) and at the end of program (48 hours after last training session).
Method of measurement
C- terminal telopeptides of type I collagen will be assessed using Hangzhou Stabiopharm kit (China), with a sensitivity of 0.01ng/ml and ELISA method.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Power trainings will be performed for 6 weeks, 5 sessions per week, 8 sets, 3 repetitions and 15 seconds rest between sets, including 5 activities (Scot, forward lounge, side lounge, cuff rise and toe rise) and to produce power in mentioned activities, the concentric phase should be done so fast in correct body straight posture. After 10 minutes of warm up the training starts and finished after 10 minutes of cool down.
Category
Prevention

2

Description
Control group: No intervention has received.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Ali Hospital
Full name of responsible person
Shila Nayebifar
Street address
Daneshgah Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9876578
Phone
+98 54 3113 6813
Email
shila_nayebifar@ped.usb.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The university of Sistan and Baluchestan
Full name of responsible person
Research minister
Street address
Daneshgah Ave.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98169654
Phone
+98 54 3113 6813
Email
shila_nayebifar@ped.usb.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
University of Sistan and Baluchestan
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
The University of Sistan and Baluchestan
Full name of responsible person
Shila Nayebifar
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 18, Danesh Ave., Daneshjo Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9897567
Phone
+98 54 3113 6813
Email
shila_nayebifar@ped.usb.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Sistan and Baluchestan
Full name of responsible person
Shila Nayebifar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
No. 18, Danesh Ave., Daneshjo Blvd.
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98976556
Phone
+98 54 3113 6813
Email
shila_nayebifar@ped.usb.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Sistan and Baluchestan
Full name of responsible person
Shila Nayebifar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 18, Danesh Ave., Daneshjoo Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816976153
Phone
+98 54 3223 8192
Email
shila_nayebifar@ped.usb.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be 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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