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The Effect of Concurrent Aerobic-ResistanceTraining Period as Well as with Tribulus supplementation on cellular enzymes, inflammatory and metabolic markers,Brain-derived neurotrophic factor, memory and sexual function of overweight postmenopausal women

Protocol summary

Study aim
The Effect of Concurrent Aerobic-Resistance Training Period with Tribulus supplementation on cellular enzymes, inflammatory and metabolic markers, Brain-derived neurotrophic factor, memory and sexual function of overweight postmenopausal women
Design
A clinical trial with a control group, an exercise group, a supplement group, a simultaneous exercise and supplement group, not blinded and non-randomized, available based on the goal, the first phase of implementing the protocol on 60 participants for 10 weeks, the second phase of follow-up on the same 60 The participant is for 3 months.
Settings and conduct
Strength training with an elastic band was 30 minutes three times a week and its intensity increased from 40% to 70% of maximum heart rate. The exercises are 9 movements to work on large and small muscle groups. 20 minutes of aerobic training program, including 5 minutes of walking with 50% of the target heart rate and 15 minutes of treadmill running at 60% to 70% target heart rate, which increased incrementally until the end of the workout.
Participants/Inclusion and exclusion criteria
All people were overweight and menopausal and complained of menopausal complications. The exclusion conditions were smoking, chronic diseases and musculoskeletal injuries.
Intervention groups
Intervention group 1, simultaneous high-intensity combined exercise, intervention group 2, tribulus supplement consumption, intervention group 3, high-intensity simultaneous combined exercise with tribulus supplement consumption, the control group, did not have any other resistance or regular training.
Main outcome variables
Brain-derived Neurotrophic Factor; Memory; Estradiol; Follicle Stimulant; Testosterone; Plasma Inflammation Index; Cell Damage Index; Cortisol; Sexual Autonomy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220821055765N1
Registration date: 2022-09-23, 1401/07/01
Registration timing: registered_while_recruiting

Last update: 2022-09-23, 1401/07/01
Update count: 0
Registration date
2022-09-23, 1401/07/01
Registrant information
Name
Roya Seighali
Name of organization / entity
Islamic Azad University Rasht Branch
Country
Iran (Islamic Republic of)
Phone
+98 13 3376 2536
Email address
r.seighaly@phd.iaurasht.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-15, 1401/06/24
Expected recruitment end date
2022-09-30, 1401/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Concurrent Aerobic-ResistanceTraining Period as Well as with Tribulus supplementation on cellular enzymes, inflammatory and metabolic markers,Brain-derived neurotrophic factor, memory and sexual function of overweight postmenopausal women
Public title
The Effect of Concurrent Aerobic-ResistanceTraining Period as Well as with Tribulus supplementation on cellular enzymes, inflammatory and metabolic markers, Brain-derived neurotrophic factor, memory and sexual function of overweight postmenopausal women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All participants have overweight. For all participants, one year passed from their last menstrual period (they are all menopause). Non of participants had hormone treatment. All participants reported difficulties from menopause. All participants had less than 1 hour exercise per week for the last year.
Exclusion criteria:
Participants who are smokers (they smoked for 6 months before starting the research). Participants with uncontrolled cardiovascular, renal, pulmonary, thyroid, and blood pressure diseases. Participants with limited mobility and musculoskeletal injury.
Age
From 55 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method, simple, lottery: In this method, 60 menopausal women with menopausal complications will be selected by available sampling method. through lottery (names of the participants are written on paper and will be divided into 4 groups (3 intervention groups and 1 control group) through random lottery).
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 Islamic Azad University, Rasht Branch
Street address
Lakan Blvd.
City
Rasht
Province
Guilan
Postal code
۴۱۴۷۶۵۴۹۱۹
Approval date
2022-08-13, 1401/05/22
Ethics committee reference number
IR.IAU.RASHT.REC.1401.009

Health conditions studied

1

Description of health condition studied
Menopause with excess weight
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states

Primary outcomes

1

Description
The role of brain-derived neurotrophic factor in the flexibility of the central nervous system, memory and its relationship with both strength and aerobic sports activities.
Timepoint
Neurotrophic factor was measured at the beginning of the study, 70 days after the intervention and 3 months after the end of the study.
Method of measurement
Measurement of neurotrophic factor with ELISA laboratory kit.

2

Description
Estradiol hormone changes.
Timepoint
Estradiol measurement was done at the beginning of the study, 70 days after the intervention and 3 months after the end of the study.
Method of measurement
Estradiol measurement by enzyme method with ELISA laboratory kit.

3

Description
Testosterone hormone changes in menopausal women.
Timepoint
Testosterone was measured at the beginning of the study and 70 days after the intervention.
Method of measurement
Testosterone measurement by enzyme method with ELISA laboratory kit.

Secondary outcomes

1

Description
Prospective and retrospective memory scores by Crawford et al based on a five-point Likert scale.
Timepoint
Memory measurement was done at the beginning of the study, 70 days after the intervention and 3 months after the end of the study.
Method of measurement
Measuring memory with Crawford et al.'s questionnaire based on a five-point Likert scale.

2

Description
Cortisol assessment after menopause.
Timepoint
Cortisol was measured at the beginning of the study and 70 days after the intervention (at 8 am).
Method of measurement
Cortisol measurement with ELISA laboratory kit.

3

Description
Anthropometric index in postmenopausal women.
Timepoint
Anthropometric measurement was done at the beginning of the study, 70 days after the intervention and 3 months after the end of the study.
Method of measurement
Anthropometric measurement by caliper with Jackson-Pollack three point method and using body density formula and Satiety equation.

4

Description
Changes in sexual self-efficacy in menopause.
Timepoint
Sexual self-efficacy was measured at the beginning of the study, 70 days after the intervention and 3 months after the end of the study.
Method of measurement
Measuring sexual efficiency with the Schwartz sexual questionnaire.

5

Description
Plasma inflammatory index in postmenopausal women.
Timepoint
The inflammatory index was measured at the beginning of the study and 70 days after the intervention.
Method of measurement
Measurement of plasma inflammatory index by immunoturbidometric method.

6

Description
Selected indicators of cell damage in postmenopausal women.
Timepoint
Variables were measured at the beginning of the study and 70 days after the intervention.
Method of measurement
Measurement of the selected index of cell damage with the German standardized enzymatic method and autoanalyzer.

Intervention groups

1

Description
Intervention group: First, high-intensity combined exercise for 10 weeks, 3 days a week and for 60 minutes each day, which included 5 minutes of warm-up, 20 minutes of aerobic exercise program, 30 minutes of resistance exercises with resistance bands. Bodybuilding and 5 minutes of cooling were done. During this period, all participants were urged to maintain their usual activities and refrain from other physical exercises.
Category
Lifestyle

2

Description
Intervention group: Second, consumption of Tribulus supplement: Tribulus supplement with Iranian name Kharkhasek and brand name Tribulus 500 mg, manufactured by Dayan Hat Company, made in Iran. Also, this supplement has phytopharmacology approval from India and China. Participants took 500 mg capsules twice a day (after breakfast and dinner) for 70 days.
Category
Lifestyle

3

Description
Intervention group: 3rd, simultaneous high-intensity combined exercise with Tribulus supplement: simultaneous high-intensity combined exercise for 10 weeks, 3 days a week and for 60 minutes every day, where bodybuilding resistance band was performed and 500 capsules Tribulus supplements were taken twice a day.
Category
Lifestyle

4

Description
Control group: The inactive control group, although they were physically active, did not participate in any resistance training or other regular training for a year before the start of the study. The passive control group continued their normal life without any changes and at the end of the study, they were compared with three other experimental groups.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Banovan Park of Rasht
Full name of responsible person
Roya Seighali
Street address
Manzariye Ave.
City
Rasht
Province
Guilan
Postal code
4168675995
Phone
+98 911 330 9968
Email
roya.seighaly@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University Rasht Branch
Full name of responsible person
Ali Delpasand
Street address
Lakan Blvd.
City
Rasht
Province
Guilan
Postal code
4147654919
Phone
+98 13 3342 2153
Fax
Email
roya.seighaly@gmail.com
Web page address
https://rasht.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Rasht Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University Rasht Branch
Full name of responsible person
Roya Seighali
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 110, Emdad Alley, Namaz Blvd., Golsar Ave.
City
Rasht
Province
Guilan
Postal code
4168675995
Phone
+98 13 3376 2536
Email
roya.seighaly@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University Rasht Branch
Full name of responsible person
Roya Seighali
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 110, Emdad Alley, Namaz Blvd., Golsar Ave.
City
Rasht
Province
Guilan
Postal code
4168675995
Phone
+98 13 3376 2536
Email
roya.seighaly@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University Rasht Branch
Full name of responsible person
Roya Seighali
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 110, Emdad Alley, Namaz Blvd., Golsar Ave.
City
Rasht
Province
Guilan
Postal code
4168675995
Phone
+98 13 3376 2536
Email
roya.seighaly@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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