To determine The effect of high intensity aerobic training and vitamin C intake on asymmetric myeloperoxidase, asymmetric dimethyl arginine, nitric oxide and catalase in hypertensive men
Design
A randomized clinical trial study with a control group ( pre-test-post-test) included three intervention , and A control group
Settings and conduct
Forty hypertensive men 30-45 from Urmia Medical Centers in a double-blind study (researchers and experimenters are unaware of vitamin C intake) were randomly assigned to three intervention groups and one control group. The aim of this study was to evaluate the effect of moderate to high intensity aerobic exercise on vitamin C in improving blood pressure. Exercises will be 10 weeks; three nonconsecutive days per week with a 75% HRmax, with 20 min.
Participants/Inclusion and exclusion criteria
- no experience in exercise training
- 30-45 yr ranges
- no smoking
- Hypertension syndrome
- Exclusion criteria
- Kidney, respiratory, diabetes and gastrointestinal problems
- Use of antioxidant vitamins during research
- No regular attendance during trainin
Intervention groups
Exercise training
Vitamin C 500 mg/d
Groups:
training+vitamin C
Training+placebo
Vitamin C
Control (without intervention)
Main outcome variables
Catalase and Nitric oxide.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191225045892N1
Registration date:2020-02-01, 1398/11/12
Registration timing:registered_while_recruiting
Last update:2020-02-01, 1398/11/12
Update count:0
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Ailin Alishahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3365 4045
Email address
ailin.alishahi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-30, 1398/11/10
Expected recruitment end date
2020-02-09, 1398/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Consuming vitamin C during High -Intensity Aerobic Training on Catalase and Nitric Oxide activity in Hypertension Men
Public title
Aerobic Training and vitamin C on Hypertension
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hypertention
age 30 - 40 years
not smoker
not exercise
Exclusion criteria:
kidney disease
pulmonary disease
Age
From 30 years old to 45 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is semi quasi-experimental study, performed as double-blind randomized clinical trial and controlled with placebo, at pretest and posttest design with control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The present study is semi quasi-experimental study, performed as double-blind randomized clinical trial and controlled with placebo, at pretest and posttest design with control group.
Placebo
Used
Assignment
Factorial
Other design features
The present study is semi quasi-experimental study, performed as double-blind randomized clinical trial and controlled with placebo, at pretest and posttest design with control group. The statistical population of this research consisted of middle-aged men within the age range of 30-45 yrs. with hypertension who had referred to the healthcare centers in Urmia city in 2017.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
IR.MUK.REC.1397.5018
Street address
adab street
City
sanandej
Province
Kurdistan
Postal code
6618634683
Approval date
2018-04-14, 1397/01/25
Ethics committee reference number
IR.MUK.REC.1397.5018
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Independent variables: aerobic exercise - vitamin C supplementation The dependent variables: Catalase, NO, myeloperoxidase, and asymmetric dimethyl arginine Systolic and diastolic blood pressure
Timepoint
The dependent variable: Once before exercise and supplementation intervention (pretest) The second time after 10 weeks of aerobic exercise and vitamin C supplementation (posttest)
Method of measurement
Systolic and diastolic blood pressure Catalase, NO, myeloperoxidase, and asymmetric dimethyl arginine in the serum
Secondary outcomes
empty
Intervention groups
1
Description
1- Exercise training- Vitamin C 2- Exercise training-placebo 3- Vitamin C and 4- Placebo (no intervention)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Medical centers of Urmia
Full name of responsible person
Kamal Azizbeigi
Street address
Adab street
City
sanandej
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Fax
+98 87 3328 8661
Email
kazizbeigi@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kamal Azizbeigi
Street address
adab street
City
sanandej
Province
Kurdistan
Postal code
618
Phone
+98 87 3328 8661
Email
kazizbeigi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Ailin Alishahi
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kamal Azizbeigi
Position
2. Ph.D in Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Adab street
City
sanandej
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
kazizbeigi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kamal Azizbeigi
Position
2. Ph.D in Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Adab street
City
sanandej
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
kazizbeigi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kamal Azizbeigi
Position
2. Ph.D in Exercise Physiology
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Adab street
City
sanandej
Province
Kurdistan
Postal code
6616935391
Phone
+98 87 3328 8661
Email
kazizbeigi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All information related to the present study is available in movie, photo, and data as an Excel file.
When the data will become available and for how long
2021
To whom data/document is available
Everyone
Under which criteria data/document could be used
Research
From where data/document is obtainable
Islamic Azad University, Sanandaj, Iran.
What processes are involved for a request to access data/document