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Investigating the effect of eight-week low-intensity endurance training with lower limb blood flow restriction on arterial blood pressure, heart performance, and serum levels of PGC1-a, Klotho, and nitric oxide metabolites in patients with mild hypertension

Protocol summary

Study aim
Determining the effect of eight weeks of low-intensity endurance training with lower limb blood flow restriction on arterial blood pressure, heart function and serum levels of PGC1-a, Klotho and nitric oxide metabolites in patients with mild hypertension.
Design
interventional study with a control group, parallel groups, and double-blinded in non-specific randomness will be used on 60 patients and three groups of 20 people.
Settings and conduct
60 retired people who have Inclusion criteria and refer to the Center for retirees after completing the consent form and performing the Astrand test are divided into 3 groups. Before the train, blood sampling and echocardiography are performed. training is performed thrice a week for 8 weeks, and blood sampling and echocardiography are performed again 24 hours after training. place of study is Kerman University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: systolic blood pressure 130-150 mmHg and diastolic blood pressure> 80 mmHg, not taking blood pressure-lowering drugs, body mass index less than 30, 50-65 years old Exclusion criteria: secondary hypertension، heart, respiratory, kidney, liver, metabolic and other chronic diseases, and smoking, narcotic and alcohol consumption
Intervention groups
1: Control group without exercise and blood flow restriction 2: The group that performs 8 weeks of low-intensity endurance exercise. 3: The group that performs 8 weeks of low-intensity endurance exercise with blood flow restriction.
Main outcome variables
PGC1α; Klotho; serum nitrite; blood pressure ; BMI; respiratory exchange ratio; ventilation ratio; PaCO2; PaO2; Echocardiographic parameters

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230528058311N1
Registration date: 2023-06-12, 1402/03/22
Registration timing: registered_while_recruiting

Last update: 2023-06-12, 1402/03/22
Update count: 0
Registration date
2023-06-12, 1402/03/22
Registrant information
Name
Maryam Doustaki Zaboli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 9462 2767
Email address
doostaki@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of eight-week low-intensity endurance training with lower limb blood flow restriction on arterial blood pressure, heart performance, and serum levels of PGC1-a, Klotho, and nitric oxide metabolites in patients with mild hypertension
Public title
Investigating the effect of eight weeks of low-intensity endurance training with lower limb blood flow restriction on arterial blood pressure and cardiac function in patients with mild hypertension
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
50 - 64 years old Body mass index (BMI) less than 30 Not consumption of blood pressure drugs systolic blood pressure: 130-150mmHg ; diastolic blood pressure>80 mmHg
Exclusion criteria:
Secondary hypertension Smoking Heart, respiratory, kidney, liver, metabolic, and other chronic diseases
Age
From 50 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Colleagues who participate in biochemical tests and data analysis do not inform about the study groups. Samples sent to the laboratory will be numbered؛ additionally, for an individual who performs the data analysis, the study groups will be indistinctive.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
The beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.KMU.AH.REC.1402.029

Health conditions studied

1

Description of health condition studied
Method of treaning to prevent high blood pressure and diminish the need to consume antihypertensive drugs.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Serum PGC1α level
Timepoint
Before starting training and 24 hours after the last training session
Method of measurement
Elisa

2

Description
Serum levels of Klotho
Timepoint
Before starting training and 24 hours after the last training session
Method of measurement
Elisa

3

Description
Serum nitrite levels
Timepoint
Before starting training and 24 hours after the last training session
Method of measurement
Photometry

Secondary outcomes

1

Description
Changes in blood pressure
Timepoint
One week after the intervention
Method of measurement
with a mercury barometer

2

Description
Left ventricular ejection fraction
Timepoint
One week after the intervention
Method of measurement
Echocardiography by a cardiologist

3

Description
Changes in biochemical parameters
Timepoint
One week after the intervention
Method of measurement
Elisa

4

Description
Left ventricular fractional shortening
Timepoint
One week after the intervention
Method of measurement
Echocardiography

5

Description
Left ventricular mass
Timepoint
One week after the intervention
Method of measurement
Echocardiography

6

Description
Posterior wall thickness
Timepoint
One week after the intervention
Method of measurement
Echocardiography

7

Description
Relative wall thickness
Timepoint
One week after the intervention
Method of measurement
Echocardiography

8

Description
Isovolumic relaxation time
Timepoint
One week after the intervention
Method of measurement
Echocardiography

9

Description
Mean left atrial pressure
Timepoint
One week after the intervention
Method of measurement
Echocardiography

10

Description
Left ventricular end-systolic diameter
Timepoint
One week after the intervention
Method of measurement
Echocardiography

11

Description
Left ventricular end-diastolic diameter
Timepoint
One week after the intervention
Method of measurement
Echocardiography

Intervention groups

1

Description
Intervention group: a group that rides a stationary bicycle at 50% VO2paek for 3 sessions a week, every other day, and each session is a maximum of 45 minutes for 8 weeks.
Category
Treatment - Other

2

Description
Intervention group: a group that rides a stationary bicycle 3 times a week, every other day, and each session is 45 minutes maximum for 8 weeks, with 50% of VO2paek, while the upper part of the thigh is closed with a cuff, blood flow restriction through closing The cuff will be applied in the proximal part of the thighs. The complete femoral artery occlusion pressure will be estimated through the following formula. Lower body arterial occlusion (mmHg) = (5.893 × thigh circumference) + (0.912 × systolic blood pressure) + (0.734 × diastolic blood pressure) 220.046 The cuff pressure in the exercises in the first and second weeks will be calculated and applied as 50% of the complete occlusion pressure (AOP).
Category
Treatment - Other

3

Description
Control group: Control group without exercise and blood flow restriction
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Center for retirees of Kerman
Full name of responsible person
Masoud Elahi
Street address
Army Street, Army Alley 12, Retired Cente
City
Kerman
Province
Kerman
Postal code
7617467334
Phone
+98 34 1226 7697
Email
doostaki@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
The beginning of Haft Bagh axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5804
Email
Iranpourabedin89@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
60
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

2

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Hamid Najafi pour
Street address
Tahmasababad intersection
City
Kerman
Province
Kerman
Postal code
7617467334
Phone
+98 34 3226 4071
Email
najfipourh@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
40
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
Kerman University of Medical Sciences
Full name of responsible person
Siavash Jokar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
At the end of 22 Bahman Blvd., Shahid Bahonar University, Afzalipur Faculty of Medicine
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3132 0500
Email
Sjokar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Siavash Jokar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
At the end of 22 Bahman Blvd., Shahid Bahonar University, Afzalipur Faculty of Medicine
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3132 0500
Email
Sjokar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Siavash Jokar
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
At the end of 22 Bahman Blvd., Shahid Bahonar University, Afzalipur Faculty of Medicine
City
Kerman
Province
Kerman
Postal code
7616914115
Phone
+98 34 3132 0500
Email
Sjokar@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The result of the study will be shared with the participants in the Rubika social network. and it will be published with Print the article.
When the data will become available and for how long
The beginning of the access period for participants in Rubika, immediately after obtaining the results and for the public after the publication of the article from 2025
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
With the permission and discretion of the person in charge of the study, the data will be available to researchers working in academic and scientific institutions.
From where data/document is obtainable
Afzalipur Faculty of Medicine, Department of Physiology by Dr. Siavash Jokar Postal code: 7616914115 Email: Sjokar@gmail.com 09132985770
What processes are involved for a request to access data/document
The study documentation can be accessed by Correspondence with the principal investigator
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