Investigating the response of hematological and hemodynamic factors to two different isometric protocols in men with high blood pressure
Design
The number of 10 subjects, based on their grouping, performed both high-intensity and low-intensity protocols in a counter balance manner.
Settings and conduct
Ten middle-aged men with high blood pressure without any other underlying illnesses with a range of 30-60 years were randomly selected. The training program included two high-intensity and low-intensity isometric handgrip (IHG) protocols. The high intensity protocol includes 8 repetitions of 30 seconds with 60% maximum voluntary contraction (MVC) with 2 minutes of rest between repetitions and the low-intensity protocol consisted of 4 repetitions of 2 minutes at 30% of MVC with 4 minutes of rest between repetitions. Three blood samples were taken before and immediately after exercise and after 20 min of recovery, and were analyzed for lactate, fibrinogen, hemoglobin and hematocrit were measured and Plasma volume changes were calculated by using the hematocrit and hemoglobin. Blood pressure and heart rate were measured at rest, immediately after exercise and at 5,10,15,30,45 and 60 minutes during recovery.
Participants/Inclusion and exclusion criteria
Ten men with primary hypertension without a history of regular sports activity with an age range of 40 to 60 years.
The subjects did not use any drugs affecting cardiovascular function, especially antihypertensive drugs. Also, the subjects did not use cigarettes, alcohol and any substance that affects blood pressure.
Intervention groups
High intensity protocol training group - Low intensity protocol training group
Main outcome variables
Although the isometric exercise induced significant changes in blood pressure, plasma volume changes and hematological variables, these changes are not acutely intensity related.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220728055573N1
Registration date:2022-08-08, 1401/05/17
Registration timing:prospective
Last update:2022-08-08, 1401/05/17
Update count:0
Registration date
2022-08-08, 1401/05/17
Registrant information
Name
Alireza Jowhari
Name of organization / entity
Shahid Beheshti University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 71 5336 3847
Email address
afjf2020@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-12, 1401/05/21
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Responses of plasma volume changes and hematological factors to two different isometric protocols in men with high blood pressure
Public title
Isometric exercises and blood flow indicators in patients with high blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
In the high blood pressure stage, the blood pressure level is 140 or above 140 mm Hg
Age range is between 40 and 60 years old
The gender of all the subjects is male
Exclusion criteria:
Having regular exercise
Age
From 40 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
Samples responding to two training models
Randomization (investigator's opinion)
Randomized
Randomization description
First, by examining the files of patients with high blood pressure referred to Shahid Rajaei Heart Hospital, the subjects who were eligible to enter the research were selected and after a phone call or face-to-face meeting and obtaining their consent, they were selected to participate in the research. After measuring the blood pressure, the subjects were placed in double blocks (five blocks) based on the blood pressure level from the highest to the lowest. Then two subjects of each block were randomly divided into two groups (low intensity protocol and high intensity protocol). In the end, 10 subjects were placed in each group and the subjects with higher blood pressure were divided into both groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Tehran
Street address
Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-08-11, 1397/05/20
Ethics committee reference number
IR.SBU.ICBS.97/1024
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Viscosity of blood and plasma
Timepoint
Before training and immediately after the training session
Method of measurement
EDTA blood sample and using a viscometer
2
Description
Hematocrit, hemoglobin, fibronogen, lactate
Timepoint
Before training and immediately after the training session
Method of measurement
Using a special diagnostic kit for each agent
3
Description
Systolic, diastolic blood pressure
Timepoint
before training, immediately after training and 5, 10, 15, 30, 45 and 60 minutes after training
Method of measurement
Digital blood pressure monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 male subjects with high blood pressure, based on their grouping in the counter balance method, performed each of the two high-intensity or low-intensity protocols with their non-dominant hand. The interval between each exercise was 48 hours.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Heart Hospital
Full name of responsible person
Mohsen Javidi
Street address
The intersection of Waliasr and Niayesh streets
City
Tehran
Province
Tehran
Postal code
1115119969
Phone
+98 21 2990 2931
Email
javidi68@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Babak Shokri
Street address
Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2236
Email
b-shokri@sbu.ac.ir
Grant name
N/A
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University
Full name of responsible person
Sajjad Ahmadizad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology of exercise
Street address
Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2931
Email
s_ahmadizad@sbu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sajjad Ahmadizad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology of exercise
Street address
Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2931
Email
s_ahmadizad@sbu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sajjad Ahmadizad
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology of exercise
Street address
Shahid Shahriari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 2931
Email
s_ahmadizad@sbu.ac.ir
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
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
N/A
When the data will become available and for how long
N/A
To whom data/document is available
N/A
Under which criteria data/document could be used
N/A
From where data/document is obtainable
N/A
What processes are involved for a request to access data/document