Protocol summary

Summary
The purpose of this study is to survey pilates exercise effects on anxiety and general health in woman patients with type 2 diabetes. 70 patients with type 2 diabetes will select. They are randomly divide to intervention and control groups. In the beginning,they will complete the Spielberg and public health(GHQ28) questionnaires.Then in the intervention group ,pilates exercise will be carried out for 8 weeks and each week two sessions.Control group during the same time will receive standard treatment.The Spielberg and public health(GHQ28) questionnaires will fill out by the patients, again. Ultimately, Two groups are compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201309018348N6
Registration date: 2013-09-20, 1392/06/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-09-20, 1392/06/29
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Pilates exercise on anxiety and general health in woman patients with type 2 diabetes
Public title
Effects of Pilates exercise on anxiety and general health
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis Blood Sugar,Allow physicians to exercise in intervention group, The lack of structural abnormalities in the spine, Type 2 diabetes is more than one year. Exclusion criteria: Complications of diabetes, Absence of more than two sessions of training sessions
Age
From 30 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Kashan University of Medical Sciences
Street address
Kashan, Ravand Street, Kashan University of Medical Sciences
City
Kashan
Postal code
8715981151
Approval date
2013-08-23, 1392/06/01
Ethics committee reference number
9269

Health conditions studied

1

Description of health condition studied
Pilates exercise
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures

Primary outcomes

1

Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Spielberger questionnaire

Secondary outcomes

1

Description
Public health
Timepoint
Before and after intervention
Method of measurement
Questionnaire (GHQ28)

Intervention groups

1

Description
In intervention group,Pilates exercise will perform two days a week for 8 weeks.
Category
Prevention

2

Description
In the control group,Pilates exercise will not performed at 8 weeks.They are receiving routine treatment at this time.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Kashan diabetes center
Full name of responsible person
Neda Mirbagher
Street address
Ravand,Parastar Street, Kashan University of Medical sciences
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Street address
Ravand,Parastar Street , Kashan University of Medical sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Ravand,Parastar Street, Kashan University of Medical sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
salam_20012003@yahoo.co.ukmirbagher_n@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
MS
Other areas of specialty/work
Street address
Ravand,Parastar Street, Kashan University of Medical sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
salam_20012003@yahoo.co.ukmirbagher_n@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Ravand,Parastar Street, Kashan University of Medical sciences
City
Kashan
Postal code
Phone
+98 36 1555 0021
Fax
Email
salam_20012003@yahoo.co.ukmirbagher_n@kaums.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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