The Effect of 6 Weeks Electro Muscle Stimulation Training and Aerobic Exercise on Body Composition, abdominal circumference, abdominal skin fold of Overweight Women
Design
Clinical trials with a control group, with parallel groups, single-blind, randomized, sample size 40
Settings and conduct
Emam Khomeini hospital and Pain and Weight Control Clinic
Participants/Inclusion and exclusion criteria
Inclusion criteria: women between the ages of 20 and 45; no disease. Exclusion criteria: musculoskeletal problem.
Intervention groups
In the intervention group, under the supervision of a specialist physician, exercise is taught with the EMS device. Then participants warm up on the treadmill for 5 minutes, then exercise with the EMS under supervision for 20 minutes and then cool down with low-intensity exercise on the treadmill for 5 minutes.
Main outcome variables
body composition; weight; body fat percentage; abdominal circumference
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111025007903N12
Registration date:2021-04-28, 1400/02/08
Registration timing:retrospective
Last update:2021-04-28, 1400/02/08
Update count:0
Registration date
2021-04-28, 1400/02/08
Registrant information
Name
Zahra Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
z_alizadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
2019-09-23, 1398/07/01
Actual recruitment end date
2019-12-01, 1398/09/10
Trial completion date
2020-02-19, 1398/11/30
Scientific title
The Effect of 6 Weeks Electro Muscle Stimulation Training and Aerobic Exercise on Body Composition of Overweight Women.
Public title
The Effect of Electro Muscle Stimulation Training on Body Composition of Overweight Women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female sex
Without a history of diseases (seizure, malignancy, uncontrolled diabetes or hypertension, severe cardiovascular diseases, musculoskeletal and neurological disorders that limited physical activity, chronic obstructive lung disease)
No drug use that affect the heart rate,
No diet
physical activity less than 90 minutes per week during recent 6 months
Exclusion criteria:
New musculoskeletal problems that limited physical activity
Signs and symptoms that put a person at high risk group for heart disease
Having a prosthetic, cardiac pacemaker or any metal or electronic device in the body
Pregnancy during the study
Refuse participation in the trial
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were entered into the study using randomized block tables. We prepared 10 blocks, four patients were considered for each block. Patient one entered block 1, patient two/block 2, patient 3/block 3… patient 10/ block 10. Then the rotation repeated again, patient 11/block 1…until patient 40/block 10, respectively. After that, the third person who he did not aware of the patients’ groups, selected 5 blocks as the control group and 5 blocks as EMS group, according to a random sequence. This method not only caused randomization to be equal in both groups but also at each stage of the study, patients were equally assigned to the groups. These small blocks kept the balance between the two groups and made the number of people in each group the same.
Blinding (investigator's opinion)
Single blinded
Blinding description
Subjects are not blind to the intervention because the intervention is an exercise with the EMS device under researcher supervision. However, the person who assessing the variables, including waist circumference, skin fold, etc. is not aware of the grouping of individuals (allocation concealment is done for the assessor).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-10-02, 1398/07/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1398.195
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66
ICD-10 code description
Overweight and obesity
Primary outcomes
1
Description
body composition
Timepoint
baseline and 6 weeks later
Method of measurement
body analysis device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: participants perform full body electrical stimulation exercise with the EMS device two days per week for 20 minutes plus aerobic exercise 3 days per week.
Category
Treatment - Devices
2
Description
Control group: Aerobic exercise is performed 3 days per week for 6 weeks.