Effect of a 12-week combined exercise training program on lipid peroxidation, total antioxidant capacity, high-sensitivity C-reactive protein, body composition, physical function, and lipid profile in women with subclinical hypothyroidism
Investigating the effect of combined exercises on lipid peroxidation, total antioxidant capacity, high-sensitivity C-reactive protein, body composition, physical performance, and lipid profile.
Design
The clinical trial has a control group and an exercise group, each group has a sample of 22 people. After completing all the initial evaluations, the subjects will be divided into the training group and the control group using two block randomization in order to balance the number of samples allocated.
Also, due to the importance of concealing the random allocation, a sealed envelope is used. It is intended to perform random blocking based on age and one of the body composition indicators such as body mass index or fat percentage.
Settings and conduct
- Location of the project: Isfahan city
- Intervention: combined exercise training (resistance and aerobic exercises)
Participants/Inclusion and exclusion criteria
• TSH between 5 and 10 mu/l
• No special disease and no medication
• Same body mass index
• No pregnant
• No regular exercise training for at least six months
• No smoking
• No alcohol consumption
• Not using food supplements containing zinc, magnesium and vitamin A during the last 3 months
Intervention groups
The control group does not receive any exercise
The intervention group receives two types of resistance training with elastic bands and aerobic training. which is resistance training with 60 to 75% of a maximum repetition in the range of 12 to 14 repetitions and aerobic exercise with an intensity of 40 to 60% of Vo2max is performed on a bicycle or treadmill ergometer
Main outcome variables
Malondialdehyde
High-sensitivity C-reactive protein
TC
TG
LDL-C
HDL-C
Total antioxidant capacity
Body fat percentage
Waist to hip ratio (WHR)
Body mass index (BMI)
"The result of the 30-second test of getting up from the chair"
"The result of the 30-second arm curl test"
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220809055643N1
Registration date:2022-08-16, 1401/05/25
Registration timing:prospective
Last update:2022-08-16, 1401/05/25
Update count:0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
Javad Najafi
Name of organization / entity
The university of Shahrekord
Country
Iran (Islamic Republic of)
Phone
+98 31 3260 5668
Email address
javad.najafi1526@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-06, 1401/06/15
Expected recruitment end date
2022-10-07, 1401/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of a 12-week combined exercise training program on lipid peroxidation, total antioxidant capacity, high-sensitivity C-reactive protein, body composition, physical function, and lipid profile in women with subclinical hypothyroidism
Public title
Effect of combined exercise training on subclinical hypothyroidism variables
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
TSH between 5 and 10 mu/l
No special disease and no medication
Same body mass index
No pregnant
no regular exercise training for at least six months before participating in this study
No smoking
No alcohol consumption
Not using food supplements containing zinc, magnesium and vitamin A during the last 3 months
Exclusion criteria:
Diagnosis of the attending physician regarding the need to withdraw from the study
Personal desire to withdraw from the study
Getting other diseases
Age
From 35 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
After completing all the initial evaluations, the subjects will be divided into the training group and the control group using two block randomization in order to balance the number of samples allocated. Also, due to the importance of concealing the random allocation, a sealed envelope is used. It is intended to perform random blocking based on age and one of the body composition indicators such as body mass index or fat percentage.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A new and safe training system, as well as exploring variables that have been less explored.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee in Shahrekord University
Street address
Shahrekord University, Blvd Rahbar, Shahrekord
City
Shahre kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818634141
Approval date
2022-07-26, 1401/05/04
Ethics committee reference number
IR.SKU.REC.1401.26
Health conditions studied
1
Description of health condition studied
Subclinical hypothyroidism
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Lipid peroxidation
Timepoint
24 hours before the beginning of the interventions - 48 hours after the end of the interventions
Method of measurement
Measurement of malondialdehyde through blood sample taken by valid laboratory kits
2
Description
Total antioxidant capacity
Timepoint
24 hours before the beginning of the interventions - 48 hours after the end of the interventions
Method of measurement
Measurement of antioxidant capacity through blood samples taken by valid laboratory kits
3
Description
C-reactive protein with high sensitivity
Timepoint
24 hours before the beginning of the interventions - 48 hours after the end of the interventions
Method of measurement
Measurement of C-reactive protein level in blood sample by valid laboratory kits
4
Description
Blood lipid profile
Timepoint
24 hours before the beginning of the interventions - 48 hours after the end of the interventions
Method of measurement
Measuring the level of lipid profile in the blood sample by valid laboratory kits
5
Description
Body fat percentage
Timepoint
24 hours before the beginning of the interventions - 48 hours after the end of the interventions
Method of measurement
Measurement of the thickness of subcutaneous fat (triceps brachialis, Supraspinatus and thigh) using calipers and formula calculations.
6
Description
Waist to hip ratio
Timepoint
24 hours before the beginning of the interventions - 48 hours after the end of the interventions
Method of measurement
Measure waist circumference at the narrowest point divided by hip circumference at the widest point
7
Description
Body mass index
Timepoint
24 hours before the beginning of the interventions - 48 hours after the end of the interventions
Method of measurement
Measure weight in kilograms by height in meters to the power of two
Secondary outcomes
1
Description
Lipid peroxidation
Timepoint
48 hours after the last training session
Method of measurement
Malondialdehyde measurement through a blood sample taken by a valid laboratory kit
2
Description
Total antioxidant capacity
Timepoint
48 hours after the last training session
Method of measurement
Measuring the antioxidant capacity of blood by valid laboratory kits
3
Description
C-reactive protein with high sensitivity
Timepoint
48 hours after the last training session
Method of measurement
Measurement of C-reactive protein level in blood by valid laboratory kits
4
Description
Lipid profile
Timepoint
48 hours after the last training session
Method of measurement
Measurement of lipid profile components in blood by valid laboratory kits
5
Description
Body fat percentage
Timepoint
48 hours after the last training session
Method of measurement
Measurement of the thickness of subcutaneous fat (triceps brachialis, Supraspinatus and thigh) using calipers and formula calculations.
6
Description
Waist to hip ratio
Timepoint
48 hours after the last training session
Method of measurement
Waist circumference at the lowest point divided by hip circumference at the widest part
7
Description
Body mass index
Timepoint
48 hours after the last training session
Method of measurement
Weight in kilograms divided by height in meters to the power of two
Intervention groups
1
Description
Intervention group: receiving a resistance exercise program with an elastic band and performing an aerobic program on a treadmill or an exercise bike.
Category
N/A
2
Description
Intervention group: Subjects in the intervention group receive two types of exercises for 12 weeks. At the beginning of each session, 10 minutes of warm-up exercises, then 5 minutes of stretching exercises - after that, 20 minutes of resistance exercises using an elastic band with an intensity of 60 to 75%, a maximum repetition in the range of 12 to 14 repetitions, and then aerobic exercises on a ergometer or Treadmill will be done with 40 to 60% Vo2max for 30 minutes, and at the end stretching movements will be done to cool down the body.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Endocrine and Metabolism Research Center
Full name of responsible person
Mr. Dr. Sasan Haghigi
Street address
Khoram Ave, Republic Square
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9933
Fax
Email
emrc@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University
Full name of responsible person
Mr. Dr. Ahmed Kiwani
Street address
Shahrekord University, Rahbar Blvd
City
Shaherkord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۸۶۳۴۱۴۱
Phone
+98 38 3232 4407
Email
Intl_ofic@cha.sku.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?