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Investigating the Effect of Aerobic Walking on Treadmill with Positive and Negative Slope on Serum Nitric Oxide Level of Type 2 Diabetic Patients

Protocol summary

Study aim
Investigating the Effect of Aerobic Training on Serum Nitric Oxide Level of Type 2 Diabetic Patients
Design
In this study, we will have two intervention group and a control group that will be identical. The sample size of each group will be at least 11, and the applicants will be randomly divided into two groups using the dice roll method.
Settings and conduct
At first, type 2 diabetic patients will enter the study according to the inclusion and exclusion criteria, and after primary assessments, they will be divided into first intervention, second intervention and control groups. The intervention groups will receive 12 sessions of intervention and and then they will be evaluated and compared with the primary results and other groups. the location of the project will be in Karaj.
Participants/Inclusion and exclusion criteria
Type 2 diabetic patients with at least 5 years disease duration Age between 40-60 years HbA1C is higher than 7% Do not take NO-releasing drugs Ability to walk without any walking aids Blood pressure is higher than 140/90 mm Hg Patients who smoke, smoke hookah and drink alcohol. Neurological diseases, orthopedic lesions, retinopathy, foot ulcer, renal failure, liver failure, respiratory failure, cardiac failure, and thyroid failure Patients with venous thrombosis.
Intervention groups
The intervention groups will have 12 sessions of 20 minutes of walking on a treadmill with a slope of 5 degrees, and the control group will not receive any intervention.
Main outcome variables
Changes in the plasma nitric oxide level before and after exercises

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190417043299N3
Registration date: 2020-08-25, 1399/06/04
Registration timing: prospective

Last update: 2020-08-25, 1399/06/04
Update count: 0
Registration date
2020-08-25, 1399/06/04
Registrant information
Name
Seyed Ahmad Bagherian
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3207
Email address
a.bagherian@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-31, 1399/06/10
Expected recruitment end date
2020-09-07, 1399/06/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Aerobic Walking on Treadmill with Positive and Negative Slope on Serum Nitric Oxide Level of Type 2 Diabetic Patients
Public title
Investigating the Effect of Aerobic Training on Serum Nitric Oxide Level of Type 2 Diabetic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients with at least 5 years disease duration Age between 40-60 years HbA1C is higher than 7% Do not take NO-releasing drugs Ability to walk without any walking aids
Exclusion criteria:
Blood pressure is higher than 140/90 mm Hg Patients who smoke, smoke hookah and drink alcohol. Neurological diseases, orthopedic lesions, retinopathy, foot ulcer, renal failure, liver failure, respiratory failure, cardiac failure, and thyroid failure Patients with venous thrombosis.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Randomized
Randomization description
The dice roll method will be used to randomize the grouping. So that the numbers 1 and 2 for the first intervention group and the numbers 3 and 4 for the second intervention group and the numbers 5 and 6 will be for the control group.
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
Committee of Ethics in Research at Tarbiat Modares university
Street address
Tarbiat Modares University, Jalal-Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2013-11-30, 1392/09/09
Ethics committee reference number
۵۲/۴۸۳۶د

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus

Primary outcomes

1

Description
Changes in the plasma nitric oxide level before and after exercises
Timepoint
Before and after the first training session and after the end of the twelfth training session
Method of measurement
By blood test

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: Applicants walk on a treadmill with a positive slope of 5 degrees for 12 sessions and 20 minutes each session. The intensity of the exercises is considered to be 65-75% of the maximum heart rate.
Category
Treatment - Other

2

Description
Control group: They will not receive any intervention.
Category
N/A

3

Description
Second intervention group: Applicants walk on a treadmill with a negative slope of 5 degrees for 12 sessions and 20 minutes each session. The intensity of the exercises is considered to be 65-75% of the maximum heart rate.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Mahdi Dehghani specialized clinic
Full name of responsible person
Mahdi Dehghani Mohammad Abadi
Street address
Unit 15, 4th floor, Noor Doctors Building, next to City Book Building, Shahid Beheshti St.
City
Karaj
Province
Alborz
Postal code
3144716458
Phone
+98 26 3421 6009
Email
mehdidehghani52@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Yaaghoub Fath Allahi
Street address
The University of Tarbiat Modares, Jalal-Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3101
Email
Res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares 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
Tarbiat Modares University
Full name of responsible person
Seyed Ahmad Bagherian
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The University of Tarbiat Modares, Jalal-Al-Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3590
Email
a.bagherian@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tarbiat Modares
Full name of responsible person
Farid Bahrpeyma
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
The University of Tarbiat Modares, Jalal-Al-Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3590
Email
bahrpeyf@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Seyed Ahmad Bagherian
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
The University of Tarbiat Modares, Jalal-Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3590
Email
a.bagherian@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All information can be shared after making the subjects unidentifiable.
When the data will become available and for how long
6 months after publication of results
To whom data/document is available
All individuals can use information about the results of the study.
Under which criteria data/document could be used
To treat diabetic patients and to carry out new research in this field, data can be used with unidentifying individuals of the study.
From where data/document is obtainable
They can contact the researcher by email They can meet the Physical Therapy Department of Tarbiat Modares University
What processes are involved for a request to access data/document
The requestor should explain the cause of the need for the data clearly and if the reasons are convincing, the data will be available to him.
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