Protocol summary

Summary
The purpose of this study will be investigation of the effect of high-intensity interval training on mechanism of reduce blood pressure induced apelin in treated hypertension elderly people. The study design will be based on non blinding. Forty five patients will be equally divided and randomized into three groups including high intensity interval training 1 and 2 and control. Inclusion criteria: will be treated hypertension elderly men; no any participant to regular exercise training for 1 year and exclusion criteria: body mass index >28; cardiovascular disease; liver and kidney disease; mental disease; functional limitation( such as osteoarthritis) and cessation of drug use during the study. Protocol of high-intensity interval training number one: including 6 intervals that each interval will be 1.5 minutes at 85-90 % HR reserve and 2 minutes active interval at 50-55%. Other high-intensity interval training including 3 intervals that each interval will be 3.5 minutes at 85-90 % HR reserve and 3.5 minutes active interval at 50-55% that undertaken for 6 weeks. Indicators of nitrate/nitrite, apelin, systolic and diastolic blood pressure will be measured before and after 6 week exercise training.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016092823002N3
Registration date: 2016-10-24, 1395/08/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-24, 1395/08/03
Registrant information
Name
Alireza Ghardashi Afousi
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 21 8201 5031
Email address
ghardashi.a@ut.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research of Tehran University (Faculty of Physical Education and Sport Science)
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high-intensity interval training on apelin-dependent mechanism in treated hypertension elderly man
Public title
Interval exercise training and the mechanism of reduced blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Including criteria: treated hypertension elderly men; no any participant to regular exercise training for 1 year and exclusion criteria will be: body mass index >28; cardiovascular disease; liver and kidney disease; mental disease; functional limitation( such as osteoarthritis) and cessation of drug use during the study.
Age
From 50 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Tehran university (Faculty of Physical Education and Sport Science)
Street address
Faculty of Physical Education and Sport Science, Above the Intersection Jalal Al-e Ahmad, North Karegar Avenue, Islamic Revolution Square
City
Tehran
Postal code
Approval date
2016-05-30, 1395/03/10
Ethics committee reference number
IR.UT.1395.198

Health conditions studied

1

Description of health condition studied
Hypertension
ICD-10 code
I10, I11,
ICD-10 code description
Hypertensive diseases

Primary outcomes

1

Description
Apelin
Timepoint
Before and after 6 week of intervention
Method of measurement
ELISA

2

Description
Nitrate/nitrite
Timepoint
Before and after 6 week of intervention
Method of measurement
ELISA

3

Description
VO2 peak
Timepoint
Before and after 6 week of intervention
Method of measurement
Gas analyser

4

Description
Resting heart rate
Timepoint
Before and after 6 week of intervention
Method of measurement
Polar beat heart rate

5

Description
Systolic and diastolic blood pressure
Timepoint
Before and after 6 week of intervention (rest, exercise, recovery)
Method of measurement
sphygmomanometer

6

Description
Fat percent
Timepoint
Before and after 6 week of intervention
Method of measurement
Caliper- Jackson and Pollock’s Equation

7

Description
Endothelin-1
Timepoint
Before and after 6 week of intervention
Method of measurement
ELISA

8

Description
Maximal heart rate
Timepoint
Before and after 6 week of intervention
Method of measurement
Polar beat heart rate

9

Description
Recovery heart rate
Timepoint
Before and after 6 week of intervention (1,2,3 minutes recovery)
Method of measurement
Polar beat heart rate

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: 6 interval (1.5 minutes at 85-90 % HR reserve with 2 minutes active interval at 50-55 % HR reserve)
Category
Rehabilitation

2

Description
Intervention group 2: 3 interval (3.5 minutes at 85-90% HR reserve with 3.5 minutes at 50-55% HR reserve)
Category
Rehabilitation

3

Description
Control group: normal condition without any exercise
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatalah Ashrafi isfahani hospital
Full name of responsible person
Narges Alsadat Zahed
Street address
Ayatalah Ashrafi Isfahani hospital, Molavi Crossroads, Molavi Square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President of Research ( Faculty of Physical Education and Sport Science)
Full name of responsible person
Alireza Ghardashi
Street address
Faculty of Physical Education and Sport Science, Above the Intersection Jalal Al-e Ahmad, North Karegar Avenue, Islamic Revolution Square.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research ( Faculty of Physical Education and Sport Science)
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi
Position
PhD
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Science, Above the Intersection Jalal Al-e Ahmad, North Karegar Avenue, Islamic Revolution Square.
City
Tehran
Postal code
Phone
+98 21 8201 5031
Fax
Email
ghardashi.a@ut.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi
Position
PhD
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Science, Above the Intersection Jalal Al-e Ahmad, North Karegar Avenue, Islamic Revolution Square.
City
Tehran
Postal code
Phone
+98 21 8201 5031
Fax
Email
ghardashi.a@ut.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Alireza Ghardashi
Position
PhD
Other areas of specialty/work
Street address
Faculty of Physical Education and Sport Science, Above the Intersection Jalal Al-e Ahmad, North Karegar Avenue, Islamic Revolution Square.
City
Tehran
Postal code
Phone
00
Fax
Email
ghardashi.a@ut.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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