Protocol summary

Summary
Objective: To determine the effect of balance training on clinical indicators of balance in obese patients seeking bariatric surgery Inclusion criteria: Obese patients with a BMI over 35 Kg/m2; surgery to shrink the stomach have been Exclusion criteria: those with a history of musculoskeletal problems, fractures; Study population: obese patients who have undergone surgery to shrink the stomach Sample size: 32 Intervention Study: balance exercises Intervention period: 4 weeks Primary outcome: Balance Sample size: 32 Intervention period: 4 weeks Intervention balance exercises

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201404262391N22
Registration date: 2014-07-04, 1393/04/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-07-04, 1393/04/13
Registrant information
Name
Zahra Rojhani Shirazi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1552
Email address
rojhaniz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
shiraz university of medical science
Expected recruitment start date
2013-12-02, 1392/09/11
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
The effect of balance training on clinical balance performance in obese subjects following bariatric surgery range 20-50 year old
Public title
Effects of balance exercises to improve balance in obese
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Obese patients with a BMI over 35 Kg/m2; surgery to shrink the stomach have been Exclusion criteria: those with a history of musculoskeletal problems, fractures;
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
N/A
Randomization description
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
SHiraz, University of Medical Science
Street address
Shiraz, CHamran, Rehabilitation College
City
Headquarters of Medical Sciences, Zand street/SHiraz
Postal code
1978-71345
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
no

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
balance
Timepoint
One time before surgery to shrink the stomach and once 4 weeks after surgery
Method of measurement
Measuring instruments: observation.lateral reach test ,sit up and go test , Star Excursion Balance Test single leg stance test

Secondary outcomes

empty

Intervention groups

1

Description
Those in the control group is not doing any exercise
Category
N/A

2

Description
Intervention group do balance exercises 45 minutes per session and 4 sessions per week for 4 weeks, do as follows : Standing on one foot , standing in tandem ( one should gradually increase the time between the last exercise ) , standing on one leg when the eye is closed , walk into a tandem ( one foot in front of the other foot ) , walking on the toes and heels, side walk when walking on a raised front legs , jumping around the seat , moving the head from side to side , walk four steps backward , twisting and Akstnd to Srhmrah by standing on one leg or tandem mode and shift weight from one foot to the other foot . Periodic exercises done without rest between workouts so that each session is 45 minutes to devote to the exercises .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
SHiraz Ghadir Hospital
Full name of responsible person
Zahra Rojhani SHirazi
Street address
SHiraz GHadir Hospital; SHiraz
City
SHiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
SHiraz University of Medical Science
Full name of responsible person
Dr Sahmoldini
Street address
SHiraz University of Medical Science, Zand street/SHiraz
City
SHiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
SHiraz University of Medical Science
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
SHiraz University of Medical Science, Rehabilitation College
Full name of responsible person
Zahra Rojhani SHirazi
Position
PHD
Other areas of specialty/work
Street address
Rehabilitation College, CHamran Street, SHiraz
City
SHiraz
Postal code
Phone
+98 77 1627 1552
Fax
Email
rojhaniz@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
SHiraz University of Medical Sciences, Rehabilitation College
Full name of responsible person
Zahra Rojhani SHirazi
Position
PHD PT
Other areas of specialty/work
Street address
Rehabilitation College, hamran, SHiraz
City
SHiraz
Postal code
Phone
+98 71 1627 1552
Fax
Email
rojhaniz@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rehabilitation College
Full name of responsible person
Zahra Rojhani SHirazi
Position
PHD PT
Other areas of specialty/work
Street address
Rehabilitation college; First Abivardi; CHamran street; SHiraz
City
SHiraz
Postal code
Phone
+98 71 1626 5108
Fax
Email
rojhaniz@sums.ac.ir
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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