Investigating The effect of foot exercise on the pain of diabetic foot neuropathy in the selected medical center affiliated to Tehran University of Medical Sciences in 2023
This study aims to determine the effect of foot exercise on the pain of diabetic foot neuropathy in patients referred to a selected medical center affiliated to Tehran University of Medical Sciences.
Design
This experimental study has a pre-test-post-test design with a randomized control group in two groups (intervention group and control group).The sampling method in this research is gradual random. The number of samples for the intervention group was 30 people and for the control group was 30 people, which were randomly selected from among the clients. Among the clients of the days in the intervention group and the clients of the even days are included in the control group.
Settings and conduct
This study will be conducted on outpatients referred to the super-specialized endocrinology and diabetes clinic of Tehran University of Medical Sciences.
In the intervention group, for 12 consecutive weeks and three days a week, between 8:00 and 13:00, one exercise set with 8-10 repetitions per hour is performed individually for each person, at the patient's bedside, in the presence of the researcher. At home, these exercises should be performed 2-3 times a day, 10 repetitions each time, and gradually the number of times increases. Patients in the control group will receive routine blood sugar control training.
Participants/Inclusion and exclusion criteria
Entry conditions: people who have HbA1C below 9/ have symptoms of neuropathy pain and have been diagnosed with neuropathy by a treating doctor/ have the ability to do foot exercises. Conditions of non-entry: unwillingness to continue cooperation/unfavorable clinical condition of the patient.
Intervention groups
In addition to following treatment regimens (following diet, taking medications), the intervention group performs leg exercises. The control group only follows the center's routine care.
Main outcome variables
neuropathic pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230429058020N1
Registration date:2023-05-07, 1402/02/17
Registration timing:registered_while_recruiting
Last update:2023-05-07, 1402/02/17
Update count:0
Registration date
2023-05-07, 1402/02/17
Registrant information
Name
Mohsen Agharazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3372 4401
Email address
mohsenagharazzi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-02, 1402/02/12
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating The effect of foot exercise on the pain of diabetic foot neuropathy in the selected medical center affiliated to Tehran University of Medical Sciences in 2023
Public title
The effect of foot exercises on the pain of diabetic foot neuropathy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
People who have HbA1C below 9 (under control of disease complications).
Fasting blood sugar should be above 126 and blood sugar two hours after eating should be above 200.
Symptoms of leg tingling, constant burning pain, and at the same time constant numbness, and the diagnosis of neuropathy has been given by the attending physician.
Have the ability to do foot exercises.
Exclusion criteria:
Unwillingness to continue cooperation.
Unfavorable clinical condition of the patient (such as hypoglycemia during exercise that leads to hospitalization of the patient).
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling of this research is random and gradual, that is, qualified people will enter the research after knowing the steps and objectives of the research and completing the consent form if they have the conditions to enter and if they do not have the conditions to not enter the research. This sampling is gradual, that is, it is done during at least one week. Eligible samples will be divided into two control and test groups by simple random sampling method. Out of the clients on odd days, they are in the intervention group and the clients on even days are in the control group
Blinding (investigator's opinion)
Single blinded
Blinding description
The number of samples for the intervention group was 30 people and for the control group 30 people, which were randomly selected from among the clients. Out of the clients on odd days, they are in the intervention group and the clients on even days are in the control group. And in this way, people do not know that they are in the intervention or control group, and the researcher knows about the condition of the participants.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشکده پزشکی دانشگاه علوم پزشکی آزاد اسلامی تهران
Street address
تهران، خیابان شریعتی، خیابان خاقانی
City
Tehran
Province
Tehran
Postal code
193951495
Approval date
2023-04-26, 1402/02/06
Ethics committee reference number
IR.IAU.TMU.REC.1402.034
Health conditions studied
1
Description of health condition studied
Diabetic neuropathy pain
ICD-10 code
E00–E90
ICD-10 code description
Endocrine, nutritional and metabolic diseases
Primary outcomes
1
Description
Diabetic neuropathy pain
Timepoint
Before and after the intervention of foot exercises
Method of measurement
Brief standardized pain intensity questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, after selecting the qualified samples and explaining about the research stages, the required concepts and the benefits of leg exercises and how to perform them, the patient's consent is obtained, and then after obtaining a written consent, in the same session, the personal information form and the questionnaire A summary of the pain intensity will be provided to the patient and after going through the above steps, for 12 consecutive weeks and three days a week between 8:00 and 13:00, one training set with 8-10 repetitions per hour individually for each person, in the bed. The patient performs leg exercises in the presence of the researcher, which will take 5-10 minutes. At home, these exercises should be performed 2-3 times a day, 10 repetitions each time, and the number of times will gradually increase, and the patients will be monitored and guided by phone calls at least once a week.Before and after performing leg exercises (before the intervention and then 12 weeks later), the patient's diabetes indicators (glycosylated hemoglobin, fasting blood sugar, blood sugar 2 hours after a meal and body mass index) are measured and recorded. Also, before and after the completion of 12 weeks, the patient's pain level is measured by a questionnaire.
Category
Behavior
2
Description
Control group: In the control group, the patient's consent will be obtained after the necessary explanations about the research steps. Then, in the same meeting, the personal information form and the brief pain intensity questionnaire form will be completed by the patient. Patients in the control group will receive routine blood sugar control training. In the twelfth week of the visit, the pain assessment form will be provided to them again for completion. The diabetes indicators of the control group patients will be measured and recorded in the same time intervals and exactly at the same time of the day and night (similar to the intervention group), pain and disease symptoms for 12 weeks as the first appointment (first session) and after 12 weeks. Then the results will be compared in two intervention and control groups.Also, after conducting the research in order to comply with the ethical points and if the patients wish, all the cases done for the intervention group will be provided to the patients of the control group in the form of a CD.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
کلینیک فوق تخصصی غدد و دیابت دانشگاه علوم پزشکی تهران
Full name of responsible person
محسن اقارضی
Street address
تهران - خیابان انقلاب ، خیابان استاد نجات اللهی ، پلاک 4 ، درمانگاه فوق تخصصی دیابت تهران
City
تهران
Province
Tehran
Postal code
1411713119
Phone
+98 21 8863 1298
Fax
+98 21 8822 0052
Email
dmclinic@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of Medicine, Islamic Azad University of Medical Sciences, Tehran
Full name of responsible person
Mehdi Vahid Dastjardi
Street address
Tehran, Khaghani St
City
Tehran
Province
Tehran
Postal code
193951495
Phone
+98 21 2200 4355
Email
tms.tehran@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Faculty of Medicine, Islamic Azad University of Medical Sciences, Tehran
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
Faculty of Nursing and Midwifery, Azad University of Medical Sciences, Tehran
Full name of responsible person
Beheshte Tabarsi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
The end of Shahid Sattari highway, Tehran
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2200 4355
Email
btabarsi@iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Azad University of Medical Sciences, Tehran