- Evaluation of the effect of six weeks of endurance training on the parameters of RMS derived from EMG in patients type 2 diabetes
- The effect of six weeks of endurance training on frequency parameters of EMG in type 2 diabetic patients
- Comparison of frequency parameters derived from EMG in type 2 diabetic patients with healthy subjects matched before exercise
- Comparison of frequency parameters of EMG in type 2 diabetic patients with healthy individuals matched after 18 sessions of endurance training
Design
In this study, a patient group was received interventions and a group of healthy individuals matched with the patient group was compared.
Settings and conduct
The location of the project Was in Karaj
Participants/Inclusion and exclusion criteria
1. Men and women aged 40 to 60 years with non-insulin dependent type 2 diabetes that past 5 to 10 years from the disease.
2. Controlled diabetes.
3. Ability to do sports movements
4. Lack of any central and peripheral neurological disease, orthopedic lesions, retinopathies, foot ulcers, renal, hepatic, respiratory, cardiac and thyroid disorders.
5. Exercise has not been carried out professionally or regularly during the past two years.
6. FBS before testing 150-110.
7. 7% <HbA1c <9%
8. Blood pressure below 90/140
9. Non-drug and alcohol addiction
10. Not having major surgery affecting the lower extremity or history of knee and ankle instability
11. The ability to maintain the state in all three basic balance tests for more than 30 seconds.
12 Neuropathy.
13- 18.5 <BMI <30
Intervention groups
In this plan, endurance training for knee muscles of patients were done that exercise intensity was between 12-15 according to the Borg Scale.
There was a healthy group for comparison with diabetics who were matched with the group of patients.
Main outcome variables
Change in frequency and time domain of EMG
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190417043299N1
Registration date:2019-06-21, 1398/03/31
Registration timing:registered_while_recruiting
Last update:2019-06-21, 1398/03/31
Update count:0
Registration date
2019-06-21, 1398/03/31
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
2019-04-27, 1398/02/07
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of 6 weeks endurance training of knee muscles on EMG parameters in patients with type 2 diabetes mellitus
Public title
Investigating the effect of endurance training on muscles in type 2 diabetes mellitus patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetic patients with 5 to 10 years disease duration
Ability to do sports movements
Not to exercise professionally or regularly during the 2 last ears
FBS before testing is 110-150
Blood pressure below 140/90
The BMI between 18.5-30
Exclusion criteria:
Neurological diseases, orthopedic lesions, retinopathy, foot ulcer, renal failure, liver failure, respiratory failure, cardiac failure, and thyroid failure
Drug and Alcohol Addiction
Problem in functional balance
Neuropathy
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:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
2019-01-27, 1397/11/07
Ethics committee reference number
IR.MODARES.REC.1397.248
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Changes in the mean frequency, median frequency and RMS of muscles before and after exercises
Timepoint
At the beginning of the study, six weeks after the initial assessment and beginning of the training, 24 hours after the end of the 18 training sessions
Method of measurement
Using the EMG device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient received 18 sessions of endurance training in 6 weeks with a weight. First, the patient's heart rate and blood glucose was recorded. The exercise program was warm-up, exercise with 60% 1RM with repetition of 25-30-35 and exercise intensity with the Borg Scale was controlled and the number of the questionnaire was 12-15, and finally the body cool-down.
Category
Treatment - Other
2
Description
Control group: Among healthy non-athlete volunteers, a group was selected which matched the age, BMI and other factors with the diabetic group. The knee muscles of this group were also recorded by EMG, which was used as a benchmark for comparison with the diabetic group before and after the 18 exercises. The healthy group did not receive any intervention.
Category
N/A
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
Bachelor
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Seyed Ahmad Bagherian
Position
Student
Latest degree
Bachelor
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 updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Seyed Ahmad Bagherian
Position
Student
Latest degree
Bachelor
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
Yes - There is 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.