Comparison of the effect of resistance training on bone mineral density and bone mineral content and bone youth index and bone age and bone area adaptation of postmenopausal and non-menopausal women with osteopenia
Design
A clinical trial with a control group with parallel blind groups is randomly assigned to 40 people with osteopenia. A lottery was used for randomization.
Settings and conduct
Subjects were selected from the Endocrine and Metabolism Research Center of the Red Crescent Subspecialty and Physical Rehabilitation Center And after examination by an endocrinologist and referral to the researcher has completed the consent and personal information And they start training at the Red Crescent Rehabilitation Center.
Participants/Inclusion and exclusion criteria
Age range 40 to 60 years Menopausal and non-menopausal women with osteopenia with body mass index between 18 to 25 No history of hormone therapy No use of any hormonal drugs during treatment No history of joint disease No history of any fractures or surgery
Intervention groups
In the experimental groups (menopause and non-menopause), resistance training due to individual differences, the intensity of training was 70 to 85% 1RM. The number of repetitions also changed from 8 repetitions to 12 repetitions from the first to the fourth month. It is 60 minutes, the researcher monitored the exercises throughout the duration, the control group did not intervene during these 4 months and continued their daily life.
Main outcome variables
Independent variable: resistance training
Dependent variables: bone mineral density, bone mineral content, T score, Z score,Bone area
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211017052792N1
Registration date:2021-11-13, 1400/08/22
Registration timing:registered_while_recruiting
Last update:2021-11-13, 1400/08/22
Update count:0
Registration date
2021-11-13, 1400/08/22
Registrant information
Name
Fatemeh Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3340 5980
Email address
lotfi@bondagroup.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of resistance training on women's bone parameters, before and after menopause
Public title
The effect of resistance training on improving bone mineral density
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Postmenopausal and non-menopausal women in the age range of 40 to 60 years with osteopenia approved by an endocrinologist
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:
Any fractures or surgery on the lower limbs and spine
hormone intake that affects bone tissue metabolism
pre-hormone therapy and exercise in the past 6 months and during the study period
people with joint diseases such as osteoarthritis and osteoarthritis In the lower limbs
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The present study consists of 4 postmenopausal groups (intervention and control) and non-menopausal group (intervention and control).
We use the classification randomization method to randomize the sample selection. In this method, participants are placed in two classes A and B based on menopausal status factor (menopause and non-menopause) and then in each class, simple randomization (lottery) is used to select samples for the intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, blindness is one-sided and due to the fact that the researcher interviews individuals personally and after the study description and obtaining written consent, puts them under medical intervention or control group, the researcher assigns individuals and groups.
It is aware and only patients do not know which group they belong to.
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
Decreased bone density in postmenopausal and non-menopausal women
ICD-10 code
M81.0
ICD-10 code description
Age-related osteoporosis without current pathological fracture
Primary outcomes
1
Description
The effect of exercise on bone mineral density
Timepoint
Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention.
Method of measurement
Bone Density Tester
2
Description
The effect of exercise on bone mineral content
Timepoint
Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention.
Method of measurement
Bone Density Tester
3
Description
The effect of exercise on bone Z- score
Timepoint
Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention.
Method of measurement
Bone Density Tester
4
Description
The effect of exercise on bone T-score
Timepoint
Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention.
Method of measurement
Bone Density Tester
5
Description
The effect of exercise on bone area
Timepoint
Measurement of bone mineral density at the beginning of the study (before the intervention) and 4 months after the intervention.
Method of measurement
Bone Density Tester
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Due to individual differences and a maximum repetition, ie the maximum weight that a person can move for one time, resistance exercises with dumbbells with an intensity of 70 to 85% of a maximum repetition and 8 to 12 repetitions on the extensor muscles of the trunk and front muscles.And the back of the foot is done for 4 months. It should be noted that the duration of the exercises, taking into account warm-up and cooling, is 60 minutes.
Category
Treatment - Other
2
Description
Intervention group 2 (non-menopausal group): Non-menopausal group such as menopausal group due to individual differences and a maximum repetition means the maximum weight that a person can move for one time. And 8 to 12 repetitions are done 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 duration of the exercises is 60 minutes, taking into account warm-up and cooling.
Category
Treatment - Other
3
Description
Control group: The postmenopausal control group and the non-menopausal control group resume their normal daily activities for 4 months and avoid taking bone density medication.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Red Crescent Rehabilitation Center
Full name of responsible person
Fatemeh Ghorbani
Street address
Red Crescent Comprehensive Rehabilitation Center,next to Khatam Al-Anbia Hospital,Rashid Yasemi St.,above Mirdamad,Valiasr St.,Tehran,