To investigate the effects of two high intensity interval training on blood rheological variables in hypertensive patients
Design
parallel group randomized clinical trial
Settings and conduct
This study was carried out at Shahid Rajaei Hospital.
Thirty hypertensive (stage 1, systolic BP >140 and diastolic BP>90 mmHg) patients (age, 47.96±3.20 yrs), were randomly allocated to short duration HIIT (SDHIIT, n=10), long duration HIIT (LDHIIT, n=10), and control (n=10) groups. After two weeks of continuous mild training, patients in SDHIIT group performed 8 weeks of HIIT included 27 min HIIT that encompassed 27 repetitions of 30s activity at 80%-100% of VO2peak interspersed by 30s passive/active (10%-20% of VO2peak) recovery, while, patients in LDHIIT group performed 8 weeks of HIIT (32min per session) included 4 repetitions of 4min activity at 75%-90% of VO2peak interspersed by 4min passive/active (15%-30% of VO2peak) recovery. Two blood samples were taken before and after training and were analyzed for hemorheological variables.
Participants/Inclusion and exclusion criteria
Prehypertension
Blood pressure 130-150 mmHg
Intervention groups
1) Control, 2) Short duration high intensity interval training (30s/30s), and 3) Long duration high intensity interval training (4min/4min).
Main outcome variables
HIIT training reduced the blood and plasma viscosity, and RBC aggregation and increased RBC deformability
General information
Reason for update
Acronym
HIIT
IRCT registration information
IRCT registration number:IRCT20160606028290N1
Registration date:2018-11-05, 1397/08/14
Registration timing:retrospective
Last update:2018-11-05, 1397/08/14
Update count:0
Registration date
2018-11-05, 1397/08/14
Registrant information
Name
Sajad Ahmadizad
Name of organization / entity
Shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 2931
Email address
s_ahmadizad@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-01, 1396/01/12
Expected recruitment end date
2017-06-01, 1396/03/11
Actual recruitment start date
2017-04-01, 1396/01/12
Actual recruitment end date
2017-06-01, 1396/03/11
Trial completion date
2018-02-20, 1396/12/01
Scientific title
Comparisons of two high intensity interval training protocols on markers of blood fluidity in hypertensive patients
Public title
High intensity interval training and markers of blood fluidity in hypertensive patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
prehypertension
Blood pressure 130-150 mmHg
Age range between 40-60 years
Exclusion criteria:
Having a regular exercise training
Age
From 40 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Pre and post training samples
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referred to Shahid Rajayee Hospital who had the inclusion criteria were initially chosen and after the telephone contact and explanation of research agreed to participate. After measuring the blood pressure all subjects were ordered from highest to lowest blood pressure were ordered and were allocated to the blocks of 3 (10 blocks). Thereafter, the 3 subjects in each block were randomly allocated to three groups (control, and 2 training groups), so that at the end there were 10 subjects in each group and the subjects with higher blood pressure were divided in 3 groups.
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
Shahid Rajaie cardiovascular center
Street address
Cross section for Vali-asr st & Hashemi Rafsanjani Hwy,
City
Tehran
Province
Tehran
Postal code
19969 11151
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
RHC.AC.IR.REC.1395.14
Health conditions studied
1
Description of health condition studied
Pre-hypertension and hemorheological variables
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
Blood and plasma viscosity
Timepoint
Before training and 48 hours after the last training session
Method of measurement
EDTA Blood and using cone plate viscometer
2
Description
RBC Aggregation
Timepoint
Before training and 48 hours after the last training session
Method of measurement
EDTA Blood and using Rheometer aggregometer
3
Description
RBC deformability
Timepoint
Before training and 48 hours after the last training session
Method of measurement
EDTA Blood and using Rheometer aggregometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: No intervention received, only two blood samples were taken before and after training and were analyzed for hemorheological variables.
Category
N/A
2
Description
Intervention group: Short duration HIIT training After two weeks of continuous mild training, patients in SDHIIT group performed 8 weeks of HIIT included 27 min HIIT that encompassed 27 repetitions of 30s activity at 80%-100% of VO2peak interspersed by 30s passive/active (10%-20% of VO2peak) recovery. Two blood samples were taken before and after training and were analyzed for hemorheological variables.
Category
Treatment - Other
3
Description
Intervention group: Long duration HIIT training Patients in LDHIIT group performed 8 weeks of HIIT (32min per session) included 4 repetitions of 4min activity at 75%-90% of VO2peak interspersed by 4min passive/active (15%-30% of VO2peak) recovery. Two blood samples were taken before and after training and were analyzed for hemorheological variables.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Heart Hospital
Full name of responsible person
Neda Aghaei
Street address
Cross-section for Vali-asr St & Hashemi Rafsanjani Hwy,
City
Tehran
Province
Tehran
Postal code
19969 11151
Phone
+98 21 2990 2931
Email
nedaghaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti Uni
Full name of responsible person
Dr. Babak Shokri
Street address
University square, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2290 2236
Email
b-shokri@sbu.ac.ir
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Uni
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 Uni
Full name of responsible person
Sajad Ahmadizad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
University square, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
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
Sajad Ahmadizad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
University square, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2931
Fax
+98 21 2243 1953
Email
s_ahmadizad@sbu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sajad Ahmadizad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Physiology
Street address
University square, Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2990 2931
Fax
+98 21 2243 1953
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