The main purpose of this study is to investigate the effect of core stability exercises on the balance in patients with type II diabetes who are residents of Semnan city.
This study is randomized, non placebo drug control, single centric and single RCT.
Participants in this study are the people who have been suffering from diabetics type II for at least five years. Their diabetics has been under control through out theses years. From other side, people with problems such as epilepsy, migraine, vertigo, cardio-vascular, renal system and liver disorders were exclusively rolled out of the study.
Firstly participants's balance was measured by Force Plate device, then they were randomly divided into intervention and control groups. Participants in intervention group went through a six weeks core stability exercise for three times per week supervised by a physical therapist. At the end, all participants in two groups remeasured balance-wise.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014080818727N1
Registration date:2014-12-18, 1393/09/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-18, 1393/09/27
Registrant information
Name
Alaleh Fardipour
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 3344 0225
Email address
alalefardipour@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
vice chancellor for research, Semnan University of Medical Science
Expected recruitment start date
2014-11-16, 1393/08/25
Expected recruitment end date
2014-12-27, 1393/10/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigashion of the effect of core stability exercises on balance parameters in type 2 diabetic patients
Public title
Investigashion of the effect of core stability exercises on balance parameters in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from diagnosed insulin independent diabetics type II by a specialized medical doctor for at least 5 years; The participant's diabetics should have been under control; Being in range of 40 to 60 years old.
Exclusive criteria:
Dependency to a type of axillary device and also other person for standing and mobility; suffering from one or each of Orthopedic disorders, Rheumatoid diseases, Foot ulcer, Neuropathy (regardless of being dependent or independent to diabetics), Neuro-muscular disorders, retinopathy; involved by renal dysfunction and liver diseases; Affected by cardio-vascular disorders; Positive vital signs instability; Taking any medications which affect postural control; Having the history of vertigo; Having problems such as epilepsy and migraine; Professional athletics and even people with regular sport program.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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
Semnan University of Medical Science
Street address
Research Deputy, Semnan University of Medical Science, Basij Blvd.
City
Semnan
Postal code
0000
Approval date
2010-07-09, 1389/04/18
Ethics committee reference number
93/470218
2
Ethics committee
Name of ethics committee
Semnan University of Medical Science
Street address
Research Deputy, Semnan University of Medical Science, Basij Blvd.
City
Semnan
Postal code
Approval date
2014-07-09, 1393/04/18
Ethics committee reference number
93/470218
Health conditions studied
1
Description of health condition studied
diabetes mellitus
ICD-10 code
E10, E11,
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Balance
Timepoint
Prior of intervention and 6 weeks after of intervention
Method of measurement
Force plate devise
Secondary outcomes
empty
Intervention groups
1
Description
interventional group: intervention is core stability exercise that included exercise increases stability of abdominal muscles and balance. pateints takes 3 sessions per week for 6 weeks.
Category
Treatment - Other
2
Description
control group: pateints don't take any exercise for 6 weeks.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center, Semnan University of Medical Science
Full name of responsible person
Alaleh Fardipour
Street address
Unit 12, NO.38, middle of 11 avenue and 13 avenue, Khosro Parviz avenue, Tehransar
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Dr Abdolhamid Hajihasani
Street address
Semnan University of Medical Science
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Science
Full name of responsible person
Alaleh Fardipour
Position
MS Student in Physical Therapy
Other areas of specialty/work
Street address
Unit 12, No.38, middle of 11 avenue and 13 avenue, Khosro Parviz avenue, Tehransar, Tehran
City
Tehran
Postal code
1388739513
Phone
+98 21 4451 6779
Fax
+98 21 8808 6400
Email
kimia1981@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Dr Abdolhamid Hajihasani
Position
PHD in Physical Therapy
Other areas of specialty/work
Street address
Research Deputy, Semnan University of Medical Science, Basij Blvd.
City
Semnan
Postal code
Phone
+98 234440225
Fax
Email
hajihasani41@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Science
Full name of responsible person
Alaleh Fardipour
Position
MS Student in Physical Therapy
Other areas of specialty/work
Street address
Unit 12, No.38, middle of 11 avenue and 13 avenue, Khosro Parviz avenue, Tehransar, Tehran
City
Tehran
Postal code
1388739513
Phone
+98 21 4451 6779
Fax
+98 21 8808 6400
Email
kimia1981@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)