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Comparison of Whole Body Vibration alone and with dynamic exercise on body composition in healthy adults

Protocol summary

Summary
The aim of this study was to evaluate the effect of Whole Body Vibration on body composition parameters in healthy adults. The study was performed on 40 obese or overweight healthy volunteers (35-18 years). Main inclusion criteria are obesity or overweight and main exclusion criteria include factors that affect body weight and cases of contraindications of Whole Body Vibration. Volunteers informed about the experimental procedure and purpose of this study. Subsequently, their written informed consent is obtained. After the registration of demographic data including age, weight, body mass index. volunteers will be randomly assigned in one of three groups: control, whole body vibration and whole body vibration with exercise. Intervention: The control group do not receive any intervention and only participate in measurements. Whole body vibration (WBV) at 30-50 HZ frequency and high amplitude is conducted for 20 minutes in the two groups. In WBV with exercise group the samples perform five dynamic exercises (biceps curl, leg abduction, lunge, calf raise, squatting) during WBV. Interventions are done 3 times per week for 8 weeks. Before and after the intervention subcutaneous fat is measured using Sahan caliper and Sonography. Measurements were performed in women in five region (Tricep,Abdominal,Thigh ,Supra iliac,Subscapular) . Measurements were performed in men in 4 region (Tricep,Abdominal, Thigh ,Supra iliac) . The fat percentage is calculated based on the formula Jackson & pollock. Waist and hip circumference are measured with a tape. Weight scales with a precision of 0.1 kg and height tape with a precision of 0.1 cm is measured and recorded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405044549N7
Registration date: 2014-06-23, 1393/04/02
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-06-23, 1393/04/02
Registrant information
Name
Elham Fatemy
Name of organization / entity
Semnan University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
fatemy@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2014-06-22, 1393/04/01
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Whole Body Vibration alone and with dynamic exercise on body composition in healthy adults
Public title
The effect of whole body vibration on obesity in healthy adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: obesity or overweight, non athlete healthy adults. Exclusion criteria: weight loss program, Irregularities in menstruation, gynecological disease,pregnancy,History of participation in strength training during the last 6 months, Medical conditions that may prohibit the patient to exercise(neck and low back pain...) , Uncontrolled hypertension, Use of drugs and other medications that effect on body composition, Neuromuscular disorders, Musculoskeletal disorder, Lower limb and spinal fracture and surgery, epilepsy, Migraine, Diabetes, Presence of renal failure, Replacement of the hip and knee, pacemaker, (Intra uterine device) IUD, internal fixator, tumors.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Sampling is convenience and the volunteers randomly are allocated to three groups by lottery.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Kilometer 5, Damghan Road
City
Semnan
Postal code
Approval date
2014-04-28, 1393/02/08
Ethics committee reference number
93/435928

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E65-E68
ICD-10 code description
Obesity and other hyperalimentation

Primary outcomes

1

Description
local fat thickness
Timepoint
Before and a day after intervention completion
Method of measurement
caliper-sonography

Secondary outcomes

1

Description
Waist circumference
Timepoint
Before and a day after intervention completion
Method of measurement
Meter

2

Description
Thigh circumference
Timepoint
Before and a day after intervention Completion
Method of measurement
Meter

Intervention groups

1

Description
Whole body vibration at 30-50 HZ frequency is used in the Whole body vibration group. The intervention is done 3 times per week for 12 weeks.
Category
Treatment - Other

2

Description
In WBV with exercise group the samples perform five dynamic exercises (biceps curl leg abduction, lunge, calf raise, squatting ) during WBV.
Category
Other

3

Description
In control group no intervention will be done.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Sciences.Semnan,Iran
Full name of responsible person
Elham Fatemy
Street address
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Semnan University of Medical Sciences
Full name of responsible person
Ali Rashidipour
Street address
Kilometer 5, Damghan Road
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham fatemy
Position
MS.c-Instructor
Other areas of specialty/work
Street address
Kilometer 5, Damghan Road ,Rehabilitation faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3332 8502
Fax
+98 23 3365 4180
Email
fatemyelham@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham fatemy
Position
MS.c-Instructor
Other areas of specialty/work
Street address
Kilometer 5, Damghan Road ,Rehabilitation faculty, Semnan University of Medical Science
City
Semnan
Postal code
Phone
+98 23 3332 8502
Fax
+98 23 3365 4180
Email
fatemyelham@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Elham fatemy
Position
MS.c-Instructor
Other areas of specialty/work
Street address
Kilometer 5, Damghan Road ,Rehabilitation faculty, Semnan University of Medical Sciences
City
Semnan
Postal code
Phone
+98 23 3332 8502
Fax
+98 23 3365 4180
Email
fatemyelham@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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