Explain the effect of 12 weeks of aerobic exercise on a selection of symptoms of heart failure in female patients with hypertension.
Design
A clinical trial with control and practice group, one-way, random and available was used on 35 patients
Settings and conduct
First, the researcher refers to Rasool Akram clinic and explains the purpose of the research to the officials. Then, with the consent of the officials, the eligible people are selected and a briefing session is held for them. The type of exercise, exercise program, steps of measuring blood pressure and heart rate in each session, the method and time of blood sampling and the results of the research are explained. Then the subjects are homogeneously divided in terms of age, weight and in 2 groups (1 control group and 1 experimental group) and the experimental group for 12 consecutive weeks in a sports training program in the gym of the Department of Physical Education located on Imam Street Khomeini Abdanan participates. In aerobic exercise, each exercise session consists of three parts: warming up, the main stage and cooling down.
Participants/Inclusion and exclusion criteria
1- Their age was between 50 and 70 years.
2- They had high blood pressure.
3- They had no history of heart and balloon surgery.
4- They were not diabetic.
5. They were non-athletes.
Intervention groups
The aerobic exercise program consisted of 12 weeks of aerobic exercise, 3 sessions per week and each session lasted 45 minutes, and the control group engaged in their normal daily activities during this time and did not engage in any exercise.
Main outcome variables
CT-1 variables; TGF-B1; NT-proBNP and systolic and diastolic blood pressure; Aerobic activity week
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200815048410N1
Registration date:2020-08-18, 1399/05/28
Registration timing:retrospective
Last update:2020-08-18, 1399/05/28
Update count:0
Registration date
2020-08-18, 1399/05/28
Registrant information
Name
somayeh abedzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3362 4252
Email address
s.abedzade89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2018-12-22, 1397/10/01
Trial completion date
2018-12-22, 1397/10/01
Scientific title
The effect of 12 weeks of aerobic exercise on a selection of symptoms of heart failure in women patients with hypertension
Public title
Evaluation of the effect of aerobic exercise in patients with hypertension
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
They were between 50 and 70 years old.
They had high blood pressure
They had no history of heart or balloon surgery
Not diabetic
Non-athletes
All subjects are in menopause
Exclusion criteria:
Exercise 6 months before the research
Cardiovascular diseases
Use of non-hypertensive drugs
Unseen 3 more sessions during the investigation
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
35
Actual sample size reached:
35
Randomization (investigator's opinion)
Randomized
Randomization description
According to a call, people with high blood pressure who live in Abdanan will be invited to participate in the study. Then, from among the volunteers, 35 people will be purposefully selected based on the inclusion criteria. Then the names of all the subjects were written on the cards and placed in a bag. Then, the cards were taken out by lottery and the person in question was placed in the intervention and control groups, respectively. After reading the card, the card was returned to the bag.
Women with hypertension with an age range of 50 to 70 years, according to the seventh report of the Joint National Committee for the Prevention, Diagnosis, Measurement and Treatment of Hypertension, in stage 1 hypertension (systolic pressure 159-140 and diastolic pressure 99-90 mm Mercury)
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
NT-proBNP concentration
Timepoint
24 hours before the start of aerobic exercise and 24 hours after 12 weeks of exercise
Method of measurement
ELISA kit made by the Chinese company Casabio to measure the amount of N-terminal pro – B-type natriuretic peptide (NT-proBNP)
2
Description
CT-1 concentration
Timepoint
24 hours before the start of aerobic exercise and 24 hours after 12 weeks of exercise
Method of measurement
ELISA kit made by the Chinese company Casabio to measure the amount Cardiotropin-1 ( CT-1)
3
Description
TGF-β1 concentration
Timepoint
24 hours before the start of aerobic exercise and 24 hours after 12 weeks of exercise
Method of measurement
ELISA kit made by the Chinese company Casabio to measure the amount Transforming growth factor beta 1(TGF-β1)
Secondary outcomes
1
Description
Systolic blood pressure
Timepoint
Before and after each workout
Method of measurement
Digital sphygmomanometer in millimeters of mercury
2
Description
Diastolic blood pressure
Timepoint
Before and after each workout
Method of measurement
Digital sphygmomanometer in millimeters of mercury
Intervention groups
1
Description
The training program consisted of 12 weeks of aerobic exercise with an intensity of 30 to 60% of the maximum heart rate, 45 minutes per session and 3 sessions per week..
Category
Other
2
Description
Control group: The control group did not participate in any training program
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Clinic
Full name of responsible person
Somayeh Abedzadeh
Street address
No.10, Shahid Darabi Alley, 15 Khordad North
City
Abdanan
Province
Ilam
Postal code
6971753469
Phone
+98 84 3362 4252
Email
s.abedzade89@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzad Movahedi Sobhani
Street address
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
f-movahedi@srbiau.ac.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
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
Islamic Azad University
Full name of responsible person
Somayeh Aabedzadeh
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No. 10, Shahid Darabi Alley, 15 Khordad North St
City
Abdanan
Province
Ilam
Postal code
6971753469
Phone
+98 84 3362 4252
Email
s.abedzade89@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Abedzadeh
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No. 10, Shahid Darabi Alley, 15 Khordad North St
City
Abdanan
Province
Ilam
Postal code
6971753469
Phone
+98 84 3362 4252
Email
s.abedzade89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Somayeh Abedzadeh
Position
PHD Student
Latest degree
Master
Other areas of specialty/work
Others
Street address
No. 10, Shahid Darabi Alley, 15 Khordad North St
City
Abdanan
Province
Ilam
Postal code
6971753469
Phone
+98 84 3362 4252
Email
s.abedzade89@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 data studied can be shared after unidentified individuals.
When the data will become available and for how long
Access information after printing results
To whom data/document is available
Available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The conditions for sending documents to the applicant will be explained.
From where data/document is obtainable
Email to the following address
s.abedzadeh89@gmail.com
What processes are involved for a request to access data/document
The applicant's request will be answered by the research team after review.