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The effects of Acute High Intensity Interval and Isometric Handgrip training on Some of hemodynamic Factors in Women With hypertention

Protocol summary

Study aim
The effects of Acute High Intensity Interval and Isometric Handgrip training on Some of hemodynamic Factors in Women With hypertention
Design
A randomized clinical trial study, single-blind, Parallel, 45 participants randomized to 2 intervention groups and a control group through web-based randomization.
Settings and conduct
Participants were equally divided into three groups of aerobic, isometric handgrip and control. This is a blind study that evaluators are about blind intervention. This study is performed in Al-Zahra Cardiovascular Hospital in Shiraz. Individuals in each group perform their desired exercise session and respond to hemodynamic factors (systolic blood pressure, diastolic blood pressure, moderate blood pressure, heart rate, myocardial oxygen cost) Women with high blood pressure in 8 times (before exercise, immediately . At the end of the exercise, 60,45,30,15,10,5 minutes of recovery period) were measured.
Participants/Inclusion and exclusion criteria
1-women with 35-55 years 2-premenopausal 3-regularly menstruating 4-free of any chronic, cardiovascular, metabolic, renal or respiratory disease 5-No physical and functional limitations 6-non-smokers 7-the Patient with high blood pressre (pre to stage 1 hypertension)
Intervention groups
3 groups: 1-high intensity interval training group: four intervals 4-minute with 85-95% of HR peak with 3 minutes of active rest between intervals of approximately 70% HR peak in one session 2-isometric handgrip exercise group: four isometric handgrip contractions 2minute with non-dominant hand in 30% intensity of maximum voluntary contraction with a 2-minute break between contractions in one session 3-control group: did not perform any specific exercise.
Main outcome variables
Systolic blood pressure, diastolic blood pressure,Mean arterial pressure, heart rate,Rate Pressure Product

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191123045478N2
Registration date: 2020-12-30, 1399/10/10
Registration timing: retrospective

Last update: 2020-12-30, 1399/10/10
Update count: 0
Registration date
2020-12-30, 1399/10/10
Registrant information
Name
Elham Shakoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3613 4630
Email address
eli_shakoor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-08-11, 1398/05/20
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-09-16, 1398/06/25
Trial completion date
2019-11-14, 1398/08/23
Scientific title
The effects of Acute High Intensity Interval and Isometric Handgrip training on Some of hemodynamic Factors in Women With hypertention
Public title
The effects of Acute High Intensity Interval and Isometric Handgrip training on high blood pressure
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
the Patient with high blood pressre (pre to stage 1 hypertension) premenopausal regularly menstruating free of any chronic, cardiovascular, metabolic, renal or respiratory disease No physical and functional limitations non-smokers
Exclusion criteria:
use of any medications that may affect blood pressure and cardiovascular responses regular exercise within the last six months history of myocardial infarction and angioplasty pregnancy abnormalities of ECG, echo, and stress test
Age
From 33 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 45
Actual sample size reached: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized into one of three groups (Two intervention and one control) using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Shiraz University of Medical Science
Street address
5th Floor, Central building of Shiraz University of Medical Sciences, Zand St., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.SUMS.REHAB.REC.1398.001

Health conditions studied

1

Description of health condition studied
blood-pressure
ICD-10 code
R03
ICD-10 code description
Abnormal blood-pressure reading, without diagnosis

2

Description of health condition studied
aerobic exercise
ICD-10 code
Y93.A3
ICD-10 code description
Activity, aerobic and step exercise

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
In eight times : before training, 0 (immediately after training), 5, 10, 15, 30, 45, 60 minutes after recovery period
Method of measurement
Digital sphygmomanometer

2

Description
diastolic blood pressure
Timepoint
In eight times : before training, 0 (immediately after training), 5, 10, 15, 30, 45, 60 minutes after recovery period
Method of measurement
Digital sphygmomanometer

3

Description
Mean arterial pressure
Timepoint
In eight times : before training, 0 (immediately after training), 5, 10, 15, 30, 45, 60 minutes after recovery period
Method of measurement
Digital sphygmomanometer

Secondary outcomes

1

Description
Heart rate
Timepoint
In eight times : before training, 0 (immediately after training), 5, 10, 15, 30, 45, 60 minutes after recovery period
Method of measurement
sphygmomanometer

Intervention groups

1

Description
Control group without exercise or Intervention: Participants in this group will have no exercise during the study
Category
N/A

2

Description
Intervention group1 high intensity interval Aerobic training: Participants do aerobic exercise for one session . The duration of each session is 40 minutes, including pre-workout warm-up, aerobic exercise program, and post-workout cooling.
Category
Treatment - Other

3

Description
Intervention group 2 isometric handgrip training: Participants do isometric handgrip exercise for one session . The duration of each session is 40 minutes, including pre-workout warm-up, aerobic exercise program, and post-workout cooling.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Heart Hospital, Shiraz
Full name of responsible person
Dr. Payman Izadpanah
Street address
Sibooye Blvd
City
Shiraz
Province
Fars
Postal code
71649-54937
Phone
+98 71 3739 8811
Email
hfcmanager@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University
Full name of responsible person
Dr seyed mojtaba zebarjad
Street address
Shiraz University, Eram Square
City
Shiraz
Province
Fars
Postal code
71946-84334
Phone
+98 71 3628 6426
Fax
Email
mojtabazebarjad@shirazu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University
Full name of responsible person
Mohsen Salesi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport science
Street address
Shiraz University, Eram Square
City
Shiraz
Province
Fars
Postal code
71964-84334
Phone
+98 71 3613 4630
Email
mhsnsls@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Elham Shakoor
Position
PhD student
Latest degree
Ph.D.
Other areas of specialty/work
Sports science
Street address
Shiraz University ,Eram Square
City
Shiraz
Province
Fars
Postal code
71964-84334
Phone
+98 71 3613 4630
Email
eli_shakoor@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University
Full name of responsible person
Elham Shakoor
Position
PhD. Student
Latest degree
Master
Other areas of specialty/work
Sports science
Street address
Shiraz University ,Eram Square
City
Shiraz
Province
Fars
Postal code
71964-84334
Phone
+98 71 3613 4630
Email
eli_shakoor@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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