The effect of ultrasound on delayed onset muscle soreness of middle-aged diabetic women after 8 weeks of aerobic exercise
Design
The clinical trial includes a sample size of 30 middle-aged women (15 in the experimental group and 15 in the control group), parallel and random groups.
Settings and conduct
Imam Ali (AS) Health Center, which is the place where diabetics are referred in Zabol city, was selected and after issuing the necessary introduction letters and permits, sampling was done during the completion period of 30 volunteers according to the study protocol. Meanwhile, the participants of the project (patients and medical staff of the center) have become blind to the study.
Participants/Inclusion and exclusion criteria
Middle-aged women (41-49 years old) with diabetes and without history of delayed onset quadriceps muscle soreness. Provide medical license to participate in sports
Intervention groups
Both study groups have the same exercise program (aerobic exercise for 8 weeks and 3 sessions of 45 minutes each week with an ergonomic bike with an intensity of 60 to 70% Vo2max) in which the Borg scale is used to vary their fatigue. In the experimental group, after training by a specialist, the ultrasound lever treats the quadriceps muscle for 7 minutes at a frequency of 3 MHz.
Main outcome variables
Delayed Onset Muscle Soreness (DOMS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211201053244N1
Registration date:2022-06-21, 1401/03/31
Registration timing:retrospective
Last update:2022-06-21, 1401/03/31
Update count:0
Registration date
2022-06-21, 1401/03/31
Registrant information
Name
Mohammadreza Rezaeipour
Name of organization / entity
University of Sistan and Baluchestan
Country
Iran (Islamic Republic of)
Phone
+98 54 3113 2241
Email address
rezaeipour@ped.usb.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Ultrasound on Delayed Onset Soreness After Aerobic Exercise in Middle Aged Diabetic Women’s
Public title
Delayed Onset Muscle Soreness (DOMS)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
diabet
middle-age
women
No movement restrictions
Exclusion criteria:
Failure to provide a permission participation in sports activities.
Age
From 41 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization model with confidential registration of the intervention and control group on paper and drawing it by the participants will be used. In this method, the type of treatment assigned to the two groups is completely unpredictable.
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 Committees of University of Sistan and Balouchestan
Street address
University of sistan and baluchestan, University Blv.
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745639
Approval date
2022-03-13, 1400/12/22
Ethics committee reference number
IR.USB.REC.1400.110
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Delayed Onset Muscle Soreness
Timepoint
The experimental group will complete the pain questionnaire one hour after the implementation of the training protocol and the use of ultrasound and 24 hours after that. The control group will complete the pain questionnaire one hour after the exercises and 24 hours later.
Method of measurement
Pain Questionnaire (based on Van Korf)
Secondary outcomes
empty
Intervention groups
1
Description
Experimental group Intervention: Aerobic training at 8 weeks and 3 sessions of 45 minutes per week on a 60-70% Vo2max ergometer bike plus ultrasound for 7 minutes at a frequency of 3 MHz on the quadriceps muscle in each session.
Category
Rehabilitation
2
Description
Control group: Aerobic training at 8 weeks and 3 sessions of 45 minutes per week on a 60-70% Vo2max ergometer bike.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Health Center
Full name of responsible person
Tahere bameri
Street address
Imam Hossein Square, 3rd Modares Blv.
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861633885
Phone
+98 54 3223 3602
Email
tahere_bameri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Sistan and Baluchestan
Full name of responsible person
ِDr. kourd (Research director)
Street address
University Blvd., University of Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816745639
Phone
+98 54 3113 6229
Email
info@usb.ac.ir
Web page address
https://www.usb.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?