Protocol summary

Study aim
Comparison of the Effect of High and Low Intensity Resistance Training on Bone Mineral Density and Bone Mineral Content and Bone Youth Index and Adaptation of Bone age and Bone area in Women with Osteopenia
Design
The Clinical Trial had a Control Group with Parallel Groups on one Side of the Blind Randomly Assigned to 45 Patients with Osteopenia A lottery was Used for Randomization
Settings and conduct
The Subjects were Selected From the Endocrine and Metabolism Research Center of the Red Crescent Sub-Specialized and Physical Rehabilitation Center. The Bone was Handed over to the Researcher and According to the Random Allocation of the Experimental Groups in the Red Crescent Rehabilitation Center they Started Training.
Participants/Inclusion and exclusion criteria
Age Range 50 to 60 Years Women With Osteopenia Menopausal Women Body Mass Index Between 18 and 25 No History of Hormone Therapy Do not Take any Hormonal Drugs During Treatment No Joint Disease No History of any Fractures or Surgery
Intervention groups
In Experimental Group 1 High-Intensity Resistance Training Due to Individual Differences in Training Intensity of 70 to 85% 1RM the Number of Repetitions from the First to the Fourth Month Changed from 6 Repetitions to 10 Repetitions Experimental Group 2 Low-Intensity Resistance Training Increased from 50% 1RM to 65% 1RM and the Number of Repetitions Varied from 10 to 16 Repetitions Each ExerciseTook a 20-Second Break The Researcher Monitored the Exercise Throughout the Allotted Time Group 3 as a Control Group that did not Experience any Intervention During these 4 Months and Continued their Daily Life
Main outcome variables
This Research can go to the Doctor Educators and Patients Information on Identifying the Most Effective Resistance Training Program to Prevent Osteoporosis and Restore It to Optimal Bone Density Levels in Postmenopausal Women with Osteopenia

General information

Reason for update
Acronym
BMD
IRCT registration information
IRCT registration number: IRCT20200829048554N1
Registration date: 2020-10-04, 1399/07/13
Registration timing: prospective

Last update: 2020-10-04, 1399/07/13
Update count: 0
Registration date
2020-10-04, 1399/07/13
Registrant information
Name
Fatemeh Eslamipor
Name of organization / entity
The University of Shahid Beheshti
Country
Iran (Islamic Republic of)
Phone
+98 25 3663 3665
Email address
f.eslamipor@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-22, 1399/08/01
Expected recruitment end date
2021-01-20, 1399/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of High Intensity and Low Intensity Resistance Traning on Bone Indexes in Wowen with steopenia
Public title
The Effect of Resistance Training to Improve Bone Mineral Density
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age Range 50 to 60 Years Women with Postmenopausal Osteopenia to be Approved by a Specialist Weight in the Normal Range and With a Body Mass Index Between 18 and 25 According to the Criteria of the World Health Organization
Exclusion criteria:
History of Any Fractures or Surgery on the Lower Limbs and Spine Taking any Hormonal Medication During Treatment that Affects Bone Tissue Metabolism History of Hormone Therapy and Regular Exercise During the Last 6 Months and During the Study Period People With Joint Diseases Such as Osteoarthritis and Osteoarthritis of the Lower Extremities
Age
From 50 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
The Sample Size of this Study is 45 People Available who Should be Divided into three Groups of 15 People In this Study Before Starting and Before Seeing the Subjects the Researcher Determines by Drawing LotsWhich Group Each Person Should be in In Fact The Researcher Makes a Random Allocation
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that The Subjects are Divided into Three Groups but all Subjects Think that There is One Group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Tehran
Street address
Shahid Beheshti University, Daneshejo blvd, Shahid Shahriari Sq, Yaman Ave, Shahid Chamran Hwy
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2020-06-20, 1399/03/31
Ethics committee reference number
IR.SBU.REC.1399.037

Health conditions studied

1

Description of health condition studied
Decreased Bone Density in Postmenopausal Women
ICD-10 code
M81.0
ICD-10 code description
Post menopausal osteoporosis without fracture

Primary outcomes

1

Description
In this Study, the Effect of Exercise on People with Osteopenia that Improves their Bone Density
Timepoint
After the Bone Density Test they are Trained for 4 Months and do the Test Again
Method of measurement
Dual Energy X-ray Absorptiometry

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: Due to Individual Differences and a Maximum Repetition, ie the Maximum Weight that a Person can Move for one Time, Resistance Training with High Intensity Dumbbells 70 to 85% A Maximum Repetition and 6 to 10 Repetitions are Performed on the Extensor Muscles of the Trunk and the Muscles of the front and Back of the Leg for 4 Months. It Should be Noted that the Exercises Lasted for 20 Minutes in the First Month and 60 Minutes
Category
Treatment - Other

2

Description
Intervention Group2: Due to Individual Differences, Resistance Exercises with Low Intensity of 50 to 65 in bad one Maximal Repetition and 10 to 16 Repetitions on Extensor Trunk and Front and Back Muscles bad Exercises are Performed for 4 Months
Category
Treatment - Other

3

Description
Control Group: In all Three Groups Medication Including Calcium and Vitamin D is Started Participants in all three Groups Follow their Previous Diet, and in the Control Group Only Medication Without Exercise Will be Applied
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Center Helaal Ahmar
Full name of responsible person
Fatemeh Eslamipour
Street address
Rehabilitation Center Helaal Ahmar, Yasmei Ste, Mirdamad Ave, ValIasr Ave
City
Tehran
Province
Tehran
Postal code
1996835611
Phone
+98 21 8820 1241
Email
info@rcs.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Fatemeh Eslamipour
Street address
Daneshjoo Blvd, Shahid Shahriari Sq, Yemen St.,Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2233
Email
pr.office@mail.sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Shahid Beheshti
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 Shahid Beheshti
Full name of responsible person
Fatemeh Eslamipour
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
NO.17, Alliy 4, Madani Ave
City
Qom
Province
Ghoum
Postal code
3719787413
Phone
+98 25 3663 3665
Email
f.eslamipor76@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Fatemeh Eslamipour
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
NO.17, Alliy 4, Madani Ave
City
Qom
Province
Ghoum
Postal code
3719787413
Phone
+98 25 3663 3665
Email
f.eslamipor76@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Shahid Beheshti
Full name of responsible person
Fatemeh Eslamipour
Position
Graduate Student
Latest degree
Bachelor
Other areas of specialty/work
Sport Medicine
Street address
NO.17, Alliy 4, Madani Ave
City
Qom
Province
Ghoum
Postal code
3719787413
Phone
+98 25 3663 3665
Email
f.eslamipor76@gmail.com

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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