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Comparison of the effect of strengthening exercises and Intermittent Pneumatic Compression (IPC) application on nitric oxide serum level and quality of life in people with type 2 diabetes neuropathy

Protocol summary

Study aim
A comparative study of the effect of resistance training and intermittent pneumatic compression on serum nitric oxide levels and quality of life in people with type 2 diabetic neuropathy
Design
A clinical trial with two groups, including strenghtening exercises and applying intermittent air pressure, with parallel groups, randomized, on a total of 20 patients with type 2 diabetic neuropathy. The lottery method was used for randomization by a neutral person outside the study.
Settings and conduct
This study is conducted on patients with type 2 diabetic neuropathy referring to clinics in Rasht city. Patients are randomly divided into two intervention groups: strength training and intermittent air pressure, and both groups are treated for 6 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: a score greater than or equal to 7 in the Michigan Questionnaire, BMI between 18.5 and 29.9, a score less than 13 in the Timed up and Go test, blood pressure 110/70 to 140/90, fasting blood sugar between 100 and 180, HbA1C between 6.5 and 9. Exclusion criteria: diabetic foot ulcer, severe retinopathy, orthopedic and neurological disease, severe cardiovascular disease, acute kidney damage, lower limb movement disorders
Intervention groups
The first group: resistance exercises of the lower limbs; It is done by applying resistance to the movements of both lower limbs using training devices. This intervention is performed for 18 sessions on 10 patients with type 2 diabetes. Second group: Intermittent Pneumatic compression; Using an air pump device, air is transferred to the cuffs of the lower limbs with alternating pressure and causes alternating pressure to be applied to the lower limbs. This intervention is performed for 18 sessions on 10 patients with type 2 diabetes.
Main outcome variables
Increase in blood serum nitric oxide; Improving the quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240611062084N1
Registration date: 2024-08-07, 1403/05/17
Registration timing: registered_while_recruiting

Last update: 2024-08-07, 1403/05/17
Update count: 0
Registration date
2024-08-07, 1403/05/17
Registrant information
Name
Mohammadjafar Zibaeebani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 3590
Email address
zibaee.mj@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-05, 1403/05/15
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of strengthening exercises and Intermittent Pneumatic Compression (IPC) application on nitric oxide serum level and quality of life in people with type 2 diabetes neuropathy
Public title
Comparison of the effect of strengthening exercises and Intermittent Pneumatic Compression (IPC) in diabetes mellitus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Score greater than or equal to 7 in the Michigan questionnaire BMI between 18.5 and 29.9 Score of at least 3 in knee and ankle muscles Getting a score less than 13 in the Timed up and Go walking test Approval of the written consent form to participate in the study Not having a regular exercise program (at least 30 minutes a day and 3 days a week) in the last year Not any physiotherapy interventions apply in the last three months The absence of any lower limb disorders that lead to the inability to perform the treatment process (such as skin problems, acute joint and muscle problems, etc.) Absence of having orthopedic and neurological diseases such as stroke, cerebral palsy, poliomyelitis, rheumatoid arthritis, prosthesis, etc. Absence of severe cardiovascular disease such as arterial and venous ulcers and acute heart disease, cardiac autonomic arrhythmia Absence of diabetic foot ulcer Absence of severe unstable proliferative retinopathy Absence of acute kidney injury requiring hemodialysis People's blood pressure should be in the range of 110/70 to 140/90 The amount of controlled FBS before interventions should be between 100 and 180 Hemoglobin glycolysis (HbA1c) less than 9 and at least 6.5
Exclusion criteria:
The patient's unwillingness to continue cooperation The appearance of symptoms of autonomic instability Occurrence of any unforeseen problems in patients
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
The people of the statistical population are randomly divided into two groups by a simple random method through the lottery of the type of therapeutic intervention by a person neutral to the study. The way of randomization is that for each sample, the name of each intervention is written by an impartial person on two sheets with the same size, shape and color and folded in the same way. Then he shakes it and throws it on the table. A sheet is randomly selected and according to the written intervention, the sample enters that 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
Ethics Committee of Tarbiat Modares University
Street address
Tarbiat modares university, Nasr bridge, Jalal al ahmad highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2024-03-11, 1402/12/21
Ethics committee reference number
IR.MODARES.REC.1402.253

Health conditions studied

1

Description of health condition studied
Diabetes type 2 neuropathy
ICD-10 code
E11.4
ICD-10 code description
Type 2 diabetes mellitus with neurological complications

Primary outcomes

1

Description
Blood serum nitric oxide level
Timepoint
Measurement of blood serum nitric oxide before the intervention and after the intervention course
Method of measurement
Blood serum nitric oxide detection kit

2

Description
Quality of life questionnaire score
Timepoint
Quality of life questionnaire scores before the intervention and after the intervention course
Method of measurement
SF 36 quality of life questionnaire

Secondary outcomes

1

Description
6 minutes walking test
Timepoint
Measuring the length of a person's walking path in six minutes before the intervention and after the end of the intervention period
Method of measurement
Using a standard meter to measure the length of the navigation path

2

Description
Tandem stance test
Timepoint
Measurement of standing time in tandem position before the intervention and after the end of the intervention period
Method of measurement
Using a stopwatch to measure time

3

Description
Timed get up and go test
Timepoint
Measuring the time of getting up and go before the start of the intervention and after the end of the intervention period
Method of measurement
Using a stopwatch to measure time

Intervention groups

1

Description
Intervention group: Strength training group using weights to resist the movements of the lower limbs
Category
Rehabilitation

2

Description
Intervention group: The intermittent pneumatic compression group uses an air pump device that transfers air to the cuffs that surround the lower limbs and causes pressure to the lower limbs.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Ali Asghar Norasteh
Street address
Razi hospital, Modafeane salamat Blvd, Beheshti Blvd, Rasht
City
Rasht
Province
Guilan
Postal code
4144895655
Phone
+98 13 3354 1001
Fax
+98 13 3355 9787
Email
razi.hospital@yahoo.com
Web page address
https://razi.gums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Amir Abdollah zadeh
Street address
Tarbiat modares university, Nasr bridge, Jalal al ahmad highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Email
prtmu@modares.ac.ir
Web page address
https://www.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
Mohammad jafar Zibaee bani
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat modares university, Nasr bridge, Jalal al ahmad highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Email
zibaee.mj@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Farid Bahrpeyma
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat modares university, Nasr bridge, Jalal al ahmad highway, Tehran
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3819
Email
bahrpeyf@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammadjafar Zibaeebani
Position
Master of science student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
No. 7, Nasr bridge, Jalal AleAhmad highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3590
Fax
+98 21 8800 4535
Email
zibaee.mj@modares.ac.ir

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
All potential data is shareable after deidentifying individuals.
When the data will become available and for how long
The access period starts 2 months after the results are published
To whom data/document is available
Access to data only for researchers of scientific and academic institutions
Under which criteria data/document could be used
The use of data and statistical analysis on them is allowed only by mentioning the source. It is allowed to be used for research and therapeutic purposes.
From where data/document is obtainable
Academic responsible for the study: Farid Bahrpeima, e-mail address: bahrpeyf@modares.ac.ir, contact number: 00982182883819 General responsible for the study: Mohammad Jaafar Zibaee Bani, email address: zibaee.mj@modares.ac.ir, contact number: 00989102085351
What processes are involved for a request to access data/document
A request to provide data and the purpose of receiving the data will be sent to the e-mail address of the person responsible for the study. Then the request will be reviewed and if the request is allowed, it will reach the requester within a month.
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