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The effect of 12 weeks of aerobic and resistance exercise on hemodynamic, biochemical and functional factors in women with hypertension

Protocol summary

Study aim
The effect of 12 weeks of aerobic and resistance exercise on hemodynamic, biochemical and functional factors in women with hypertension
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: aerobic, isometric, handgrip and control. This is a blind study that evaluators are about blind intervention. This study is performed in Alzahra Cardiovascular Hospital in Shiraz. Individuals in each group perform the exercise in 3 session for 12 weeks. In order to measure the effects of exercise on the hemodynamic, biochemical and function factors of women with hypertension are measured before and after 12 weeks.
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 3 session for 12 weeks 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 3 session for 12 weeks 3-control group: did not perform any specific
Main outcome variables
Cortisol, Nitric Oxide, Endothelin-1, Total Antioxidant Capacity, Reactive oxygen species, Peripheral Vascular Resistance, Endothelial-dependent vasodilation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191123045478N1
Registration date: 2020-12-16, 1399/09/26
Registration timing: prospective

Last update: 2020-12-16, 1399/09/26
Update count: 0
Registration date
2020-12-16, 1399/09/26
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
2020-12-22, 1399/10/02
Expected recruitment end date
2021-02-23, 1399/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 12 weeks of aerobic and resistance exercise on hemodynamic, biochemical and functional factors in women with hypertension
Public title
The effect of 12 weeks of aerobic and resistance exercise on blood pressure
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
the Patient with high blood pressre (pre to stage 1 hypertension) premenopausal free of any chronic, cardiovascular, metabolic, renal or respiratory disease No physical and functional limitations non-smokers Age between 33 to 55 years
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 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
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
2020-06-22, 1399/04/02
Ethics committee reference number
IR.SUMS.MED.REC.1399.178

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
Cortisol
Timepoint
Before and after intervention
Method of measurement
With ElISA kit

2

Description
Nitric Oxide
Timepoint
Before and after intervention
Method of measurement
With ElISA kit

3

Description
Endothelin-1
Timepoint
Before and after intervention
Method of measurement
With ElISA kit

4

Description
Total Antioxidant Capacity
Timepoint
Before and after intervention
Method of measurement
With ElISA kit

5

Description
Reactive oxygen species
Timepoint
Before and after intervention
Method of measurement
With ElISA kit

6

Description
Peripheral Vascular Resistance
Timepoint
Before and after intervention
Method of measurement
with Doppler ultrasonography

7

Description
Endothelial-dependent vasodilation
Timepoint
Before and after intervention
Method of measurement
with Doppler ultrasonography

Secondary outcomes

1

Description
Systolic blood pressure
Timepoint
Before and after intervention
Method of measurement
Digital Aneroid Sphygmomanometer Measure

2

Description
diastolic blood pressure
Timepoint
Before and after intervention
Method of measurement
Digital Aneroid Sphygmomanometer Measure

3

Description
Mean arterial pressure
Timepoint
Before and after intervention
Method of measurement
Digital Aneroid Sphygmomanometer Measure

4

Description
Heart rate
Timepoint
Before and after intervention
Method of measurement
Digital Aneroid Sphygmomanometer Measure

Intervention groups

1

Description
Control group without exercise or Intervention: Participants in this group will have no exercise during the study
Category
Treatment - Other

2

Description
Intervention group 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 and 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, Al-Zahra Heart Hospital,
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 of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
7th floor, Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz,
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir/fa/index.html
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
30
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 of Medical Sciences
Full name of responsible person
Dr Payman Izadpanah
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Cardiology
Street address
Sibooye Blvd, Al-Zahra Heart Hospital,
City
Shiraz
Province
Fars
Postal code
71649-54937
Phone
+98 71 3739 8811
Email
paymanizadpanah@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
Master
Other areas of specialty/work
Sports science
Street address
Eram Square، Shiraz University
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
Eram Square , Shiraz University
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)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is 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
Title and more details about the data/document
The data can publish for publishing paper
When the data will become available and for how long
The study protocol will be available after publishing the paper
To whom data/document is available
everyone
Under which criteria data/document could be used
For future studies
From where data/document is obtainable
Via email
What processes are involved for a request to access data/document
The applicant needs to introduce his/her and need to explain the purpose of request as well. The information will send you as soon as possible.
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